Objective: Several drugs can cause analytical interference in clinical laboratory tests.  To prevent errors in clinical judgment as a result of false data, we investigated the information available on the interference of ethical drugs in these tests.
Methods: We examined the information available by collecting and evaluating information in package insert leaflets, collecting and evaluating clinical data on three drugs (bucillamin, captopril, and epalrestat) which affect clinical laboratory test results, and conducting a questionnaire survey of healthcare workers.
Results: From the information available on package inserts, 227 drugs were identified as having the potential to interfere with the chemical reactions used in clinical laboratory tests.  However, the insert information is not sufficient for use in clinical settings because the frequency rate and causative factors of interference are not stated clearly.  The clinical survey results reveal that 40% of patients taking bucillamine and 20% of patients taking epalrestat tested false-positive for urinary ketones.  According to the questionnaire results, medical technologists were more interested than pharmacists and physicians in how drugs affect clinical laboratory tests.
Conclusion: The information currently available on the interference of drugs in clinical laboratory tests is problematical, and it is therefore necessary to collect more clinical data for the proper interpretation and evaluation of abnormal laboratory values.

Objective: The purpose of this study is to compare the clinical efficacy between original drugs and generic products.  Candidate drugs included two types of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors, simvastatin and pravastatin, because of their importance at reducing the health expenditure for hyperlipidemia.
Design: We retrospectively evaluated the efficacy (total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein levels), safety (biochemical parameters), and medication adherence based on patient data.  We set the follow-up period at 6 months before and after substitution.  Data were analyzed by paired-sample t-tests (statistical significance level of 0.05).
Methods: The subjects included in this study were ambulatory patients visiting Nakajima Hospital for dyslipidemia treatment.  Selected patients included those taking both the original drug and the generic product; i.e., patients who had substituted the original drug Lipovas® for the generic product Simvastatin OHARA, or those who had substituted the original drug Mevalotin® for the generic drug Pravatin®.
Results: A total of 118 patients in the simvastatin study and 43 patients in the pravastatin study were candidates for the present study.  We found that there were no significant differences before and after substitution.  Even though there were differences in some of the biochemical parameters, the range remained within normal levels.  With regard to medication adherence, we found no significant differences.
Conclusion: In this study, we found no significant differences before and after substituting medications with generic drugs.  Additionally, we found no subjective symptom changes after substitution.  To develop clinical information on generic products and to store such information, it is important that pharmaceutical products be used appropriately.

PURPOSE: Small bowel obstruction (SBO) remains a common complication after pelvic or abdominal surgery. However, the risk factors for SBO in ulcerative colitis (UC) surgery are not well known. The aim of the present study was to clarify the risk factors associated with SBO after ileal pouch-anal anastomosis (IPAA) with a loop ileostomy for patients with UC. METHODS: The medical records of 96 patients who underwent IPAA for UC between 1999 and 2011 were reviewed. SBO was confirmed based on the presence of clinical symptoms and radiographic findings. The patients were divided into 2 groups: the SBO group and the non-SBO group. We also analyzed the relationship between SBO and computed tomography (CT) scan image parameters. RESULTS: The study included 49 male and 47 female patients. The median age was 35.5 years (range, 14–72 years). We performed a 2- or 3-stage procedure as a total proctocolectomy and IPAA for patients with UC. SBO in the pretakedown of the loop ileostomy after IPAA occurred in 22 patients (22.9%). Moreover, surgical intervention for SBO was required for 11 patients. In brief, closure of the loop ileostomy was performed earlier than expected. A multivariate logistic regression analysis revealed that the 2-stage procedure (odds ratio, 2.850; 95% confidence interval, 1.009–8.044; P = 0.048) was a significant independent risk factor associated with SBO. CT scan image parameters were not significant risk factors of SBO. CONCLUSION: The present study suggests that a 2-stage procedure is a significant risk factor associated with SBO after IPAA in patients with UC.
Colitis, Ulcerative* ; Female ; Humans ; Ileostomy* ; Logistic Models ; Male ; Medical Records ; Risk Factors ; Tomography, X-Ray Computed ; Ulcer*

Objective: The Risk Minimization Plan is developed in the Risk Management Plan (RMP), patient information materials are sometimes prepared as Additional Risk Minimization Activities (ARMA). On the other hand, there are many patient information materials that are not prepared as RMP materials, but are prepared independently by pharmaceutical companies and are actually used to provide information to patients. However, there is no detailed report on the differences between them. Therefore, in this report, we investigated for description of Important Identified Risks (IIRs) and Important Potential Risks (IPRs) in patient information materials.Methods: The previously published RMP of 588 drugs were obtained on October 1,2020, and used in analysis. We surveyed the description of IIRs and IPRs in patient information materials, and compared patient information materials based on ARMA in the RMP (patient information materials as RMP materials) and patient information materials developed independently by pharmaceutical companies that are not based on ARMA in the RMP (patient information materials as not RMP materials).Results: Of the 588 drugs, 454 drugs had patient information materials. In addition, 241 drugs had patient information materials as RMP materials. One thousand fifteen of the 1,577 IIRs were listed in the patient information materials as RMP materials (64.4%listing rate). One hundred sixty-six of the 724 IPRs were listed in the patient information materials as RMP materials (22.9%). On the other hand, 700 of the 1,131 IIRs were listed in the patient information materials as not RMP materials (61.9% listing rate). Ninty one of the 447 IPRs were listed in the patient information materials as not RMP materials (20.4%).Conclusion: It was found that there was no difference in the description of IIRs and IPRs between patient information materials as RMP materials and patient information materials as not RMP materials.