Management of Adverse Reactions to Contrast Media and the Involvement of the Pharmaceutical Department in Hospitals: a Questionnaire Survey / 医薬品情報学

Objective: Adverse reactions are sometimes induced by contrast media used for medical imaging and can be life-threatening. Thus, appropriate management is important for patient safety. The purpose of this study was to clarify the actual management of adverse reactions induced by contrast media in hospitals, the opportunities for intervention by hospital pharmacy departments and the attitudes of hospital pharmacists regarding the risk of adverse reactions.Methods: A self-administered questionnaire survey was conducted in the pharmacy departments of 16 hospitals (approximately 200 to 1,000 beds) located in the Tokyo metropolitan area of Japan. The survey asked about the presence or absence of internal rules or manuals regarding contrast media administration at each hospital, the management status of patients with risk factors for adverse reactions, the opportunities for interventions by pharmacists, and the opportunities for discussion regarding contrast media administration among pharmacists and other professionals.Results: Of the 16 hospitals, 10 responded to the questionnaires, and 7 of them had internal rules or manuals. These rules or manuals stipulated actions such as “do not administer contrast media” to patients with risk factor(s) for adverse reactions. For inpatients, there were opportunities for pharmacist interventions, such as drug management and guidance services and initial interviews upon hospital admission. However, for outpatients the opportunities for interventions were limited. At 5 of the 10 hospitals, pharmacists discussed contrast administration with physicians, radiologists, and other healthcare professionals.Conclusion: The present study reveal that many hospitals take great care in deciding on the administration of contrast media to patients at risk of adverse drug reactions. Our results indicate that the limited opportunities for “outpatient intervention" is an issue in the hospital pharmacy department's participation for proper use of contrast media.

The Actual Status of Handling Prescription Refills in Community Pharmacies and Pharmacists' Awareness of the Refill-Prescription System / 医薬品情報学

Objectives: A refill-prescription system startedin April, 2022 in Japan. Refill-prescriptions can be usedrepeatedly, but pharmacists are required to check patients' medication and determine whether refills are appropriate. This study aimed to clarify the actual status of community pharmacies' treatment of prescription refills and pharmacists’ concerns about them.Design: Questionnaire survey.Methods: A self-administered questionnaire survey was conducted for pharmacists at community pharmacies from June to July, 2022, shortly after the refill-prescription system was launched, focusing on handling of prescription refills in community pharmacies, and concerns and challenges about refill-prescriptions.Results: Responses were obtainedfrom 377 pharmacists in 34 prefectures throughout Japan. Among them, 30.8% had received refill-prescriptions. Many pharmacists checked medical histories, changes in patients' symptoms, and medication and medical examination status when determining the appropriateness of refills, but few reviewed past laboratory values or laboratory values measuredby patients themselves at the time of their pharmacy visit. Moreover, 34.8% of the pharmacies had internal rules for dealing with refills, and 39.8% had equipment to measure laboratory values. Many pharmacists were concerned about how to share patients’ information with other pharmacies. Challenges that were identified included “Determining whether the refill is appropriate for the patient” and “Establishment of a pharmacy system to receive refill-prescriptions”.Conclusion: This study clarified the actual status of community pharmacies handling of prescription refills, and pharmacists' concerns or challenges about them. Potential improvements include increasing the number of devices that can measure laboratory values at pharmacies, improving home-use measuring devices, creating guidelines to determine the appropriateness of prescription refills and improving pharmacists' skills.

Organizing Information on “Dangerous Drugs” Published in Weekly Magazines and Evaluating Its Relevance / 医薬品情報学

Objective: Recently, special features on “dangerous” prescription drugs have been frequently published in few mass media platforms, such as weekly magazines. However, to our knowledge, there have been no prior studies, systematically organizing and evaluating the contents of these articles (e.g., drugs and their side effects that are reported). In this study, we aimed to evaluate the relevance of the information on “dangerous drugs” that was published in weekly magazines using the modified “Media Doctor” instrument.Methods: We extracted articles on “dangerous” prescription drugs from 10 weekly magazines for which the table of contents of previous issues are available on their official websites. Information regarding the target drugs and their classifications was compiled and organized. The relevance of the extracted news articles was assessed by two independent evaluators. The evaluation index was based on the modified “Media Doctor” instrument, and 9 evaluation criteria were used to assign the following categories: satisfactory, unsatisfactory, or not applicable.Results: A total of 1,064 articles were screened, and 19 articles were selected for further evaluation. A total of 179 drugs (belonging to 34 drug classes) were listed. The most frequently mentioned class of drugs included hypnotics and sedatives, and the most frequently listed was triazolam. Of the 19 articles, 11 had zero items that were judged satisfactory by both the evaluators. The number of unsatisfactory items was widely distributed, but in 11 of the 19 articles, five and more items were judged unsatisfactory by both the evaluators.Conclusion: We revealed that a wide variety of drugs have been termed as “dangerous” by weekly magazines. Additionally, we found that these articles were inadequate and incomplete with respect to scientific validity, and that there are many aspects that require further improvement.

Analysis of Risk Factors for Ganciclovir-Induced Thrombocytopenia and Construction of Risk-Prediction Models Using a Decision Tree Analysis / 医薬品情報学

Objective: Hematological toxicity, including neutropenia and thrombocytopenia, is a typical side effect of ganciclovir (GCV). We previously developed a risk-prediction model for GCV-induced neutropenia using decision tree (DT) analysis. By employing the DT model, which is a flowchart-like framework, users can predict the combination of factors that may increase neutropenia risk. However, a risk-prediction model for thrombocytopenia has not been established. Here, we aimed to identify the risk factors associated with GCV-induced thrombocytopenia and construct risk-prediction models.Method: We retrospectively evaluated the medical records of 386 patients who received GCV between April 2008 and March 2018 at Hokkaido University Hospital. Thrombocytopenia is defined as a decrease in the platelet count (PLT) to ＜50,000 cells/mm3 and to a ＜75% decrease. Risk factors of thrombocytopenia were extracted from the medical records using a multiple logistic regression analysis. Moreover, we employed chi-squared automatic interaction detection (CHAID) and classification and regression tree (CRT) algorithms to develop the DT models. The accuracies of the established models were evaluated to assess their reliability.Results: Thrombocytopenia occurred in 47 (12.2%) patients. In the multiple logistic regression analysis, data of patients with white blood cells ＜7,000 cells/mm3,PLT＜101,000 cells/mm3 and total bilirubin ≥ 0.8 mg/dL were extracted. Two risk-prediction models were constructed, and patients were divided into six and seven subgroups. In both algorithms, data on hematopoietic stem cell transplantations, PLT ＜101,000 cells/mm3, serum albumin ＜ 2.8 g/dL, total bilirubin ≥ 0.8 mg/dL, and residence in intensive care unit were extracted. The predictive accuracy of both the CHAID algorithm and the logistic regression models was 87.8% and that of the CRT algorithm was 88.3%, indicating they were reliable.Conclusion: We successfully identified the factors associated with GCV-induced thrombocytopenia and constructed useful flowchartlike risk-prediction models.

Evaluation of Predictive Accuracy between Two Types of Vancomycin TDM Analysis Software / 医薬品情報学

<b>Objective: </b>To attain optimal blood concentration rapidly, it is needed to perform initial dose setting appropriately when vancomycin (VCM) used.  In order to design initial dose settings of VCM more currently, we compared the predictive performance of two types of VCM therapeutic drug monitoring (TDM) analysis software retrospectively.<br><b>Method: </b>We utilized two TDM analysis software, SHIONOGI-VCM-TDM ver.2009 (VCM-TDM) and “Vancomycin MEEK TDM analysis software Ver. 2.0” (MEEK), based on patient’s background. 112 patients who received VCM and performed TDM were analyzed during the period from October 2011 through September 2012 and compared the actual trough level with the predictive trough level.  The predictive performance was evaluated by calculating ME (mean prediction error), MAE (mean absolute prediction error), and RMSE (root mean squared error).  Age, gender, and a renal function were evaluated as patient’s background.<br><b>Results: </b>VCM-TDM gave good predictive performance for patients overall.  When classified patient’s background complexly (sex, age, and renal function), as for male patients, VCM-TDM showed good predictive performance except for the group over 65 years old and CCr over 85 mL/min.  For female patients, the difference of predictive performance was not accepted by all groups.<br><b>Conclusion: </b>These results suggest, for male patients, we should use VCM-TDM for initial dose settings except for the group over 65 years old and over CCr 85 mL/min.  For the other patients, we consider that both of software can be used.  These new findings seem to contribute to proper dosage settings of VCM.