Objective: Confirmation by pharmacists of brought-in drugs is not only limited to identification of drugs, but also requires prescription design and proposals based on the background of patients and evaluation of associated information. In this study, we analyzed the content of brought-in drugs related PreAVOID reports in our hospital according to the years of pharmacist experience in order to help educate pharmacist for better brought-in drugs confirmation.Method: Various interventions regarding brought-in drugs were compared between two groups: pharmacists with >6 years of experience (group H) and those with < 5 years of experience (group L). PreAVOID reports, which related to drugs brought in by patients admitted to the Ogaki Municipal Hospital between April 1, 2018 and March 31, 2019 were assessed.Result:The PreAVOID reporting rate for the number of brought-in drugs confirmed was higher in group H (1.56%) than in group L (1.12%) (odds ratio 1.399, p = 0.023). The PreAVOID reporting rate when reporting was based solely on prescription information did not differ between these two groups, but when patient background, including disease-related information, was included with prescription information, the rate was higher in group H (0.80%) than in group L (0.30%) (odds ratio 2.725, p < 0.001). Group H provided more reports related to unnecessary drugs.Conclusion: The involvement of pharmacists in the evaluation of brought-in drugs is important when reviewing subsequent medical treatments. Our findings suggest that to improve the quality of treatment, it is necessary to provide appropriate newcomer education, such as conducting case studies using PreAVOID cases.

STUDY DESIGN: Retrospective and comparative study. PURPOSE: We assessed surgical treatment outcomes in patients with thoracic myelopathy due to ossification of the ligamentum flavum (OLF), and OLF combined with ossification of the posterior longitudinal ligament (OPLL) or vertebral fracture (VF) at the same level. OVERVIEW OF LITERATURE: OLF and OPLL cause severe thoracic myelopathy. Osteoporotic VF commonly occurs at the thoracolumbar junction. There have been no investigations of thoracic myelopathy due to OLF and VF. METHODS: Forty patients were divided among three groups: the OLF group (n=23): myelopathy due to OLF, the OLF+OPLL group (n=12): myelopathy due to OLF and OPLL, and the OLF+VF group (n=5): myelopathy due to OLF and VF. We recorded OLF, OPLL, and VF sites and operative procedures. Each patient’s neurological status, according to the Japanese Orthopaedic Association (JOA) score, and walking ability were evaluated pre- and postoperatively. RESULTS: Patients in the OLF+OPLL group were significantly younger than those in the other two groups. The preoperative JOA score was significantly lower in the OLF+VF than OLF group. The final JOA score was significantly lower in the OLF+VF than OLF and OLF+OPLL groups. The JOA score recovery rate was significantly lower in the OLF+VF than OLF group. Final walking ability was significantly worse in the OLF+OPLL and OLF+VF groups than in the OLF group and significantly worse in the OLF+VF than OLF+OPLL group. CONCLUSIONS: Thoracic myelopathy due to OLF+VF occurs primarily in older females, who also exhibit worse preoperative and postoperative neurological status, and worse walking ability, than patients with thoracic myelopathy due to OLF or OLF+OPLL.

OBJECTIVES: The purpose of this survey was to explore physicians' opinions to identify an adequate time range for clinical information to be provided with a referral that would help minimize wasteful retesting. METHODS: In 2011, we conducted a questionnaire survey of 193 physicians. Examining the degree of utilization of provided medical information, we determined the range of clinical information of referral documents. RESULTS: Less than three months of prescription history and blood sample test results in patient referral was most frequent. Less than one year of image information was most frequent. Most doctors answered there is no need to repeat the same type of blood test in their institute when they had information less than half a month old. Less than half to one month of image information was most frequent. Also, it appeared many doctors think “fundamentally they do not change their mind from their own medical department standpoint.” At the actual site, those who would even review referral clinical notes accounted for about 30% of all participants. CONCLUSIONS: Medical referral eventually takes place after the establishment of mutual communication and should consider the workflow and system environment of the receiver of the information.
Asian Continental Ancestry Group* ; Hematologic Tests ; Hospital Information Systems ; Humans ; Prescriptions ; Referral and Consultation* ; Surveys and Questionnaires

SS-MIX is a product of Ministry of Health's healthcare information exchange promotion project. Its standardized storage stores prescription orders, laboratory test results, diagnosed disease classifications in HL7 v2.5 format. This can be connected to any vendorʼs hospital information system, provided that the system can export these information in HL7 format. The storage software can be downloaded from site of SS-MIX consortium. The stored standardized information can be used in many effective ways. Providing the information of the patient in a referral document form is easy. The server can be set in another place for the purpose of providing backup in case of disaster, natural or man-made, like system down, or network failure. Filling case card, like adverse event report, is also easy, by picking up the prescription, lab results, etc. and filling them into appropriate space, which are formerly filled by human hand, on paper, or through EDC. In Japan, SS-MIX standardized storage is in service at more than 116 hospitals (by March 2012). The coverage of patients by these hospitals are estimated around 1,500,000 people. Hospital information system in Japan must comply safety guideline by the Ministry, so that the electronic medical records can be　used instead of paper records. Audit　trails are mandated, and many human factors are recommended. As most hospital information systems in Japan are complying this Ministry　guideline, gap between complying 21 CFR Part 11 is not a hard task for them. (Jpn J Pharmacoepidemiol 2013;18(1):49-56)

The Standardized Structured Medical record Information eXchange (SS-MIX) was started in 2006 as the project supported by the Ministry of Health, Labour and Welfare (MHLW) for promoting the exchange of the standardized medical information. Free soft wares developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). We encourage the use of the SS-MIX standardized storage for postmarketing surveys and clinical studies. The recommendations consist of the following 7 parts. [1] In surveys and clinical studies, the information of drugs and laboratory test results in the SS-MIX standardized storage can be directly transferred to the electronic questionnaire and the investigators may obtain the information with high accuracy and granularity. [2] The SS-MIX standardized storage works as the backup system for the HIS because it can provide the minimum information essential in patient care even under the disastrous condition like earthquake or unexpected network failure. [3] The SS-MIX standardized storage may be useful to conduct a good pharmacoepidemiology study not only because it provides the information in the storage efficiently but also it can be used to identify “new users” who started the drug after some period of non-use.The “new user” design is often essential to have the unbiased results. [4] When the drug company conducts postmarketing surveys according to the current regulation, the use of the SS-MIX standardized storage will facilitate the fast and efficient collection of data to develop the timely measure to minimize the drug-related risk. With the SS-MIX standardized storage, it is also expected that many types of study design can be employed and the quality of data is improved in the survey. [5] The SS-MIX standardized storage maybe also useful to evaluate the risk minimization action plan by comparing the prescription pattern or incidence of the targeted adverse event between two periods before and after the implementation of the action plan. [6] In planning clinical trials, the SS-MIX standardized storage may be used to estimate the size of eligible patients. The storage may also allow conducting cross-sectional studies to know characteristics of diseases or drug treatment. In addition, cohorts of those who had coronary artery angiography, new users of a drug and those with a rare disease may be readily identified. Using such cohorts, investigators can initiate a case-control study nested within the cohort, pharmacogenomic studies and comparative effectiveness researches. [7] The SS-MIX standardized storage may be used as the formal data source in clinical trials in the future when some conditions are satisfied. For instance, the formal agreement should be reached between industry, government and academia on the use of standards of data structure in Clinical Data Interchange Standards Consortium (CDISC) and on the operation of computerized system validation (CSV) in the clinical trials.

No abstract available.
Anonyms and Pseudonyms ; Search Engine

Objective: Standardized clinical data are invaluable for secondary use of medical information. We constructed a standardized database and a data warehouse called D*D, based on the Standardized Structured Medical Information Exchange(SS-MIX)scheme. D*D enables physicians and researchers to perform complex searches with combined conditions, e.g. time to event. It contains data from 1999 for approximately 400,000 individual patients. The objective of this study was to provide an overview of the features of this database system, especially from the perspective of drug safety research.
Methods: Three models of research questions were identified from established drug-risk combinations:1)gatifloxacin and hypoglycemia;2)statins and rhabdomyolysis;and 3)oral 5-fluorouracil S-1 and hepatotoxicity. D*D was searched using predefined keywords and conditions.
Results: 1)A total of 3,635 patients were treated for diabetes. Among 20 diabetic patients prescribed gatifloxacin, hypoglycemia was recorded in one patient(1/38 prescriptions). 2)Among 5,926 patients who had been prescribed any statin within 10 years in our hospital, 6 patients(0.1%)experienced rhabdomyolysis. The incidence was similar to that for fibrate (1/740, 0.1%). The most confounded diagnosis was stiff shoulder. 3)Among 244 patients prescribed S-1, 19 patients(7.8%) experienced hepatotoxicity higher than CTCAE grade3 within 2 months from the prescription.
Conclusion: With limited data items and search keys in standardized data storage, definitions of exposures and outcomes require careful assessment during protocol development. Considering that the system can be implemented at more than half of the hospitals that have already installed ordering systems, D*D can be one of the Japanese models for distributed research network.

A 45-year-old man was admitted with several histories of cerebral infarction. Transesophageal echocardiography showed a small tumor on the anterior mitral leaflet. Open heart surgery was performed. The tumor was removed including a part of the anterior mitral leaflet and mitral valve plasty was done. The post-operative course was uneventful. Papillary fibroelastoma was diagnosed pathologically. To avoid embolic complication, an early surgical procedure is recommended.

The Immunosuppressive effects of prostaglandin E₁ (PGE₁) used in cardiopulmonary bypass (CPB) operation were studied. We examined 30 patients, with ischemic heart diseases. The patients were divided into 3 groups: 11 patients given PGE₁ in group PG (G-PG), 10 patients given amurinon, a phosphodiesterase inhibiter, in group A (G-A), and 9 patients not given either of those drugs in the control group (G-C). Immunologically, lymphocyte subpopulations, and adhesion molecule expression on cell membrane and phagocytosis of neutrophils were analyzed before, at the time of, and after the operation until POD 7. The prominent effects of PGE₁ were observed on neutrophils. The expression of CD 62L, an adhesion molecule designated as L-selectin, on the cell surface membrane of neutrophils significantly increased during and after CPB in G-A and G-C, but it remained unchanged in G-PG during the observation period. Moreover, CPB caused an enhancement of the phagocytic activity of neutrophils in all groups, but its degree was much less in G-PG than in the other two groups. Among lymphocyte subpopulations, the number of CD 3⁺T-cells in G-PG rather than that of CD 20⁺B-cells reduced more greatly than those values observed in G-A and G-C. The decrease of T-cell number, throughout the observation period, in G-PG seemed to be mainly due to the decrease of the number of CD 4⁺T-cells designated as helper T-cells, although the number of CD 8⁺T-cells esignated as killer/suppressor T-cells slightly decreased on PODs 3 and 7. Amurinon, as a whole, did not exert any significant effect either on lymphocytes or on neutrophils in our experiments. Taken together, these results show that the treatment of patients with PGE₁ during CPB causes suppressive effects on immunorelevant cells. It may mitigate the activity of neutrophils, which are suspected as a possible culprit causing reperfusion injury. However, these suppressive effects, including the lowered numbers of CD 4⁺T-cells, may render the patients more vulnerable to infection. Much more intensive cares is required in these patients after operations.