Experimental Study about Appropriate Time for Compounding Equal Volume Mixture of Heparinoid Oil-Based Cream and Steroid Cream Using Planetary Centrifugal Mixer / 医薬品情報学

Objective: The measurement of compounded topical medications’ uniformity is an important component of quality assessment. This study was aimed to evaluate appropriate mixing time for external preparations using a planetary centrifugal mixer.Methods: In order to evaluate the product uniformity of mixtures of five different steroid cream (Antebate®, Myser®, Methaderm®, Lidomex®, and Locoid®) with three different heparinoid oil-based cream (Hirudoid®, “Nichi-Iko” cream and “Nipro” cream), steroid cream and heparinoid oil-based cream (5 g each) were added into a 13 mL container and mixed using the mixer (NanKo Rentaro NRE-120®, THINKY) at rotation speed of 800 rpm and revolution speed of 2,000 rpm. We sampled 0.1 g of the mixture from three spots (top, middle, and bottom portions) of the container then, measured the steroid content by HPLC method. The yield value points of each cream and heparinoid oil-based cream were also measured by spread meter.Results: Our results showed that when the coefficient of variation (CV) is less than 15.2 %, a mixing time of at least 120 s was required to achieve proper mixing to obtain the permissible limit of steroid cream and heparinoid oil-based cream. Also the greater difference of the yield value between steroid cream and heparinoid oil-based cream tended to be mixed easier.Conclusions: These results suggest that the spread ability of steroid cream and heparinoid oil-based cream affects the mixing efficiency of a planetary centrifugal mixer.

Task Force Report on the Validation of Diagnosis Codes and Other Outcome Definitions in the Japanese Receipt Data / 薬剤疫学

Although the recent revision of the ministerial ordinance on Good Post-marketing Study Practice (GPSP) included the utilization of medical information databases for post-marketing surveillance, there has been limited research on the validity of diagnosis codes and other outcome definitions in Japanese databases such as administrative claims (“receipt”) database. This task force proposed how to conduct good validations studies, based on the narrative review on around 100 published papers around the world. The established check list consists of ： (ⅰ) understanding the type of the database (e.g. administrative claims data, electronic health records, disease registry) ； (ii) understanding the setting of the validation study (e.g. “population-based” or not) ； (iii) defining the study outcome ； (iv) determining the way of linkage between databases ； (v) defining the gold standard ； (vi) selecting the sampling method (e.g. using the information of all patients in the database or a hospital, random sampling from all patients, random sampling from patients satisfying the outcome definition, random sampling from patients satisfying and not satisfying the outcome definition, “all possible cases” method) and sample size ； (vii) calculating the measures of validity (e.g. sensitivity, specificity, positive predictive value, negative predictive value) ； and (viii) discussing how to use the result for future studies. In current Japan, where the linkage between databases is logistically and legally difficult, most validation studies would to be conducted on a hospital basis. In such a situation, detailed description of hospital and patient characteristics is important to discuss the generalizability of the validation study result to the entire database. This report is expected to encourage and help to conduct appropriate validation studies.

The Retrospective Chart Review : Prevalence of Incidents Related to Brought-in Medicine / 社会薬学

<p>Consultations with patients who bring drugs, especially on the high risk drug list, to a hospital is an important role of pharmacists. However, many incident reports occur though pharmacists generally make an effort to check such medications. In Japan, incidents are mostly reported just in terms of numbers but not in terms of the prevalence of a target group. We aim to reveal the prevalence of incidents related to medicine brought-in by patients undergoing surgery in National Hospital Organization (NHO) hospitals. For our study, we extracted patients undergoing surgery who were prescribed antidiabetic agents from the Medical data bank (MIA) in NHO. Chart reviews were performed on patients to evaluate the number of incidents in relation to brought-in medicine. The prevalence of incidents of interest was 4.4% (41/931, 95%CL : 3.2-5.9%). Pre-avoidable incidents represented 56.1% (23/41, p<0.0001). We found that pharmacists play a role in making incidents less severe.</p>