Recent recalls of many generic drugs caused by violations of Good Manufacturing Practice (GMP) rules have caused a severe shortage of the products and associated substantial impact on the medical care system. This mini review introduces the 15-year activities of the Expert Committee on Quality of Generic Drug Products (ECQGDP), which was established to discuss issues related to the quality of generic drugs by the Ministry of Health, Labour and Welfare. The ECQGDP coordinates an annual specification test program of generic drugs performed by official medicines control laboratories. In addition, the ECQGDP performs comparative dissolution tests using four dissolution media at different pHs to avoid significant non-bioequivalence between products, and impurity analysis of injection formulations of brand and generic products. Some properties of formulations that are not listed in their specifications (eg, adhesion durability of patch formulations) were also discussed to avoid their significant difference in usability between the products. The committee also assesses issues of generic drugs reported in literatures, academic conferences, and inquiry calls to the PMDA. Discussions at the ECQGDP have led to improvements in many products. The improved collaboration of the quality testing and GMP inspections should significantly reduce compliance issues in pharmaceutical manufacturing.

Community pharmacists are responsible for continuously checking patient medication use (follow-up). Follow-up is conducted during the medication period, so if it can be conducted after sharing clinic-owned patient information, such follow-up may be effective. This study examines the feasibility of follow-up by a pharmacy in collaboration with a clinic and the patient information that can be used for follow-up, and compares the change in the perspective of follow-up by sharing clinic-owned patient information with that using only pharmacy-owned patient information. From June 12 to August 7, 2021, 44 patients whose prescriptions were issued by Shiba Daimon Imazu Clinic and dispensed by Keio University Community Pharmacy were eligible for follow-up. By sharing clinic-owned information (laboratory data, medical interview data, and medical record data), the information utilized was analyzed. Follow-up of 43 patients (98％) was feasible after sharing clinic-owned information. The most frequently utilized information was laboratory data related to liver function, renal function, and serum lipids. The most frequently confirmed items based on the pharmacy-owned patient information were medication adherence and physical condition after adding new prescriptions (15 and 14 cases), while the items based on shared information were chief complaint, blood test values, and lifestyle (11, 7, and 6 cases). The clinic-owned information, such as blood test values, which is difficult to share at receipt of prescription, could be shared before follow-up. Sharing clinic-owned patient information makes it possible to conduct follow-up from the perspective of patient background, suggesting the usefulness of sharing clinic-owned information for patient’s medication management.

In recent years, new methods have been developed to prevent exposure during preparation and administration of injectable anticancer drugs, but similar measures for oral anticancer drugs have not been sufficiently studied. Therefore, we quantitatively compared various simple suspension methods to prevent exposure during tube administration of hazardous drugs. Pharmacists in our hospital prepared simulated oral drugs via the cup, injector and quick bag methods (with or without flush). We then measured the time from preparation to administration and scattering status for each method. We also conducted a qualitative questionnaire survey on the different methods. The scattering number was smallest in the quick bag method (without flush). With the cup method, scattering varied depending on pharmacist experience and was significantly higher if the pharmacist had less than four years of experience. In contrast, the scattering area tended to be larger in the injector method, although this did not reach significance. Preparation time was longest with the quick bag method (with flush). With the injector method, preparation time varied depending on pharmacist experience and was significantly shorter if the pharmacist had more than five years of experience. In customer satisfaction analysis, the cup method had the most priority improvement items and no important maintenance items. These data show there is considerable risk of exposure during tube administration of hazardous drugs with all the simple suspension methods examined. The quick bag method (without flush) is considered to be the most efficient and safe method with the lowest risk of exposure.

Task shifting and task sharing are expected to improve the work environment and provide high-quality medical and attentive care by demonstrating the expertise of each participating medical professional.

We conducted a survey to clarify the current status and characteristics of task shifting and task sharing in a recovery rehabilitation ward. In this study, we defined the pharmacist’s prescription change proposal and follow-up after the prescription change as task sharing; we defined the pharmacist’s prescription substitution change according to protocol as task shifting. The study covered all prescriptions for inpatients admitted to a recovery rehabilitation ward from April 2020 to March 2021. Of these, prescriptions that were changed for any reason were categorized into prescriptions changed by a physician and prescriptions changed at the suggestion of a pharmacist. Additionally, reasons for the prescription changes were investigated. The number of prescription substitution changes authorized by pharmacists according to protocol was also studied. The total number of prescription changes recorded during the study was 1,862; of these, 474 (25％) were authorized by pharmacists. Prescription changes involving a switch from “bring-your-own” medications or maintain/improve adherence characterized a high percentage of pharmacists’ changes. The total number of prescriptions investigated in this study was 5,522, of which 40 (approximately 1％) were changed according to a prior agreed-upon protocol. Further, 257 (approximately 5％) were changed according to a prescription change substitution protocol. Findings of the study indicate that task shifting and task sharing could contribute to improving the quality and safety of medical care.

Proteinuria and hypertension are commonly observed during bevacizumab (BV) therapy. This study retrospectively investigated the relationship between elevated blood pressure during BV therapy and the development of proteinuria in patients with malignant tumors of the female genital tract treated with BV. Seventy-nine patients treated with BV at Shimane University Hospital between April 2015 and March 2020 were enrolled in the study. The highest values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during BV therapy were both significantly higher in the proteinuria group than the non-proteinuria group. Receiver operating characteristic curve analysis showed that the cutoff values for urinary protein expression were 154.5 mmHg for SBP and 100.5 mmHg for DBP, respectively. Stratified analysis showed that the highest SBP during BV treatment was significantly associated with the development of proteinuria regardless of stratification factors. Multivariate logistic regression analysis showed that the highest SBP was a significant risk factor for the development of proteinuria, independent of the positive urine protein dipstick test before starting BV therapy and the presence of combination treatment with renin-angiotensin system inhibitors. Furthermore, restricted cubic spline analysis indicated a significant dose-response association in the relationship between the elevation of highest SBP and the risk of proteinuria development. These results suggest the risk factor for the development of proteinuria in BV therapy is that SBP elevates above 154.5 mmHg during BV therapy in patients with malignant tumors of the female genital tract.