Objective: When responding to questions regarding drug-drug interaction by the medical staff of our hospital, pharmacists previously collected information using some drug databases from Japan and the United States. The aim of this study was to construct a search system for interaction information using drug databases from both Japan and the United States for streamlining questions and answers regarding drug-drug interaction. Methods: Using the drug databases from Japan and the United States, we collected information on the interaction pertaining to drugs prescribed at Kobe University Hospital. This information was further assessed for consistency. Furthermore, we constructed an original search system for interaction information for streamlining questions and answers regarding drug-drug interaction. Results: The difference between information obtained from the databases from Japan and the United States was apparent. Thus, we concluded that it was necessary to obtain interaction information via a database search that included information from both the countries. Therefore, our original interaction search system was reconstructed with interaction information collected using databases from both the countries. We compared the response to questions regarding the previous and present methods using our original search system for interaction information; the time required to obtain the responses was 5.89 and 3.09 min, respectively, and it took lesser time for providing responses than the previous method. Conclusion: We evaluated the usefulness of the original search system for interaction information. We found that the original system provides a more rapid response to questions compared with the previous method. We are considering a further upgrade and update for the original system by adding information on drugs not prescribed by our hospital.
Objective: Numerous new drugs have been developed in recent years, making the available types of prescription drugs quite diverse, with increasingly more complex drug interactions. From an operations support system perspective, hospitals that cannot incorporate a large-scale custom-order system because of financial or use-efficiency limitations have no choice but to rely on commercial products. However, this leaves many problems unsolved, such as functional restrictions and limited specifications. In this study, we used Microsoft®Visual Basic®for Application (VBA) to develop an economical drug discrimination system suited to our situation and equipped with original function from the perspective of clinical pharmacists. Design: System design and development. Methods: We prototyped the system in VBA and used Microsoft®Excel®to create Query Tables. The utility of the new system was evaluated based on drug discrimination output and time required in each process. Results: The new system is capable of inter-database communication and automated data analysis and uses drop-down lists of pre-defined options for data input in many places. Compared with the conventional method, the new system enabled us to significantly reduce the average time needed to input and confirm data by as much as 61.9%. This indicates that the new system can considerably reduce the time required for completing time-intensive processes and is also useful in preparing highly precise drug discrimination reports. Conclusion: Based on the results obtained so far, the new, original system, developed with zero design or development costs, is more efficient and offers more reliable information in the clinical setting than the conventional system. As a result, we are able to maintain operational quality and reduce the amount of time required for drug discrimination.
Objective: The aim of this study was to analyze the factors influencing the addition of clinically significant adverse reactions (CSDR) section in drug package inserts in Japan. Methods: The summaries of investigation results from August 2011 to July 2014 were evaluated. The revisions were classified into revisions based only on case reports from Japan ([Revision Y]) and revisions based on other information and/or case reports from Japan ([Revision X]). The revisions were classified into MedDRA system organ class (SOC). As index of amount of information from domestic case reports, the number of accumulated cases ([Case A]), cases for which a causal relationship to the product could not be ruled out ([Case B]), and fatal cases ([Case C]) were used. In each SOC, as index of causal relationship to the product, [Index B/A] ([Case B]/[Case A]) was calculated. Relationship of [Index B/A] to [Revision X]/all revisions, or to the number of [Case A] in [Revision Y] were evaluated. Deference of drug lag between [Revision X] and [Revision Y] was evaluated. Results: Three hundreds twenty-three revisions with respect to the addition of CSDR section were identified. [Revision Y] was 203 revisions (63%). The number of [Case A], ([Case B], and ([Case C]) that were required for [Revision X] (120 revisions) were significantly lower than that were required for [Revision Y] (p<0.0001 for all comparisons). [Index B/A] tended to inversely correlate with [Revision X]/all revisions (r=−0.52, p=0.066), and the number of [Case A] in [Revision Y] (r=−0.61, p=0.025). Drug lag of [Revision X] was significantly longer than that of [Revision Y] (p<0.001). Conclusions: In future, it would especially needed to pay attention to adverse reactions with a low [Index B/A] of which revisions relatively depend on other information.
Objective: This study aimed to confirm whether the methods for assessing the reported causal relationship between dietary supplement intake and adverse events are reliable in the clinical setting. Design: The relationships between supplement intake and adverse events were assessed using two algorithms proposed in our previous report, and causal relationships were evaluated. Methods: Twelve raters with a high probability of handling adverse event information examined 200 records of dialogues with supplement users. Each rater independently assessed the causal relationship using the two algorithms. The relationships between supplement intake and adverse events were assessed for all 200 cases. Variability in the evaluation among raters was analyzed for each occupation and the whole group of raters. The distributions of evaluation were analyzed, and inter-rater reliability was evaluated using the intraclass correlation coefficient (ICC) and Fleiss’ kappa coefficient. Results: All events of 200 cases seemed to be slight and within the range of variation in daily life. Almost all cases were classified into two categories as “Possible” and “Lack of Information” by each rater. The ICC values for all raters, pharmacists, dieticians, and health care workers were 0.644, 0.573, 0.678, and 0.694, respectively, and the kappa coefficients using the two algorithms were 0.466, 0.426, 0.468, and 0.519 and 0.481, 0.478, 0.465, and 0.517, respectively. There were moderate levels of agreement based on the kappa coefficients and ICC values. Conclusion: The two algorithms proposed in our previous report may be reliable in the clinical setting. Their reliability could be enhanced by establishing a unified method of accumulation and recording adverse events for supplement intake, which should be evaluated by more raters using more cases of adverse events.
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.
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