Objective: The risk management plan (RMP) is a useful information source for healthcare professionals, including pharmacists, to ensure drug safety. The “risk minimization activities” (RMA) of the RMP are especially important elements for healthcare professionals. It is known that “Medication Guides for Patients” (MGP) and “Early post-marketing phase vigilance” (EPPV) are items listed as part of the RMA. However, the creation of MGPs and the implementation of EPPVs are not performed for all medicines. In a previous study, it was difficult to evaluate this sufficiently with the safety specifications. The aim of this investigation was to evaluate RMAs, especially MGPs and EPPVs, not in terms of the safety specifications of RMP.

Methods: The previously published RMPs of 177 drugs were obtained on February 22,2016, and used in the analysis. The relationship between the creation of the MGP and the description in the RMA and the relationship between the conduct described in the EPPV and the description in RMA was investigated for each medicine.

Results: An MGP was created in 151 of the analyzed drugs. Of these, it was not listed in the RMA of 40 drugs. In contrast, EPPV was not listed in RMA in 2 out of 33 drugs when underway. EPPV was described in the RMA of 33 of the EPPV finished drugs. The time lag from the end of EPPV until the revision of the RMP was 4.5 month son average.

Conclusion: MGPs and EPPVs are created especially for drugs requiring patient education, information provision, or safety monitoring. Therefore, for drugs for which MGPs or EPPVs are required, they should be listed in the RMA. In this study, the time lag of RMP revision was also highlighted as a problem. In order to promote the utilization of RMP by pharmacists, these issues should be resolved.

Objective: Anticancer drugs have carcinogenic potential and are associated with occupational exposure risks among healthcare

professionals who handle them. To minimize occupational exposure, healthcare workers must be adequately aware of the risks of

anticancer drugs and the appropriate techniques for their preparation. However, there is little information on the awareness of

pharmacists who prepare anticancer drugs in medical settings. The aim of this study was to investigate awareness of hazardous drugs

(HD) and appropriate preparation techniques among pharmacists, and identify problems that pharmacists experience in managing their

exposure to anticancer drugs.

Design: Questionnaire.

Method: The questionnaire was sent by e-mail or mail to pharmacists employed at 270 institutions who belonged to the Chiba Society

of Hospital Pharmacists. From September 2015 to March 2016, respondents completed the questionnaires voluntarily and returned

them by mail. Returning the questionnaire was regarded as informed consent to participate in this survey. Based on the completed

questionnaires, we examined the awareness of pharmacists in their daily work.

Results: In total, 218 questionnaires were returned (collection rate: 10%). Awareness of the risks of anticancer drugs was high, and a

high percentage of respondents use personal protective equipment during drug preparation, but the use of closed system drug transfer

devices was low. Overall, however, it was found that many pharmacists had insufficient understanding of safe handling techniques.

Discussion: Despite some recognition of the risks associated with exposure to HD, the measures taken to prevent exposure to

HDs―including anticancer drugs―were inadequate and this issue must be urgently addressed by medical institutions and pharmacists.

Countermeasures such as training sessions in the handling of HDs and the development of manuals are needed for each facility.

Objective: We conducted a survey on drug information accumulated by pharmaceutical companies about the adequacy of administration of crushed or simply suspended internal medicines through enteral feeding tube, examination methods to confirm adequacy and inquiries from medical institutions to pharmaceutical companies about the adequacy of these methods.

Methods: We sent a questionnaire to 162 pharmaceutical companies that sell internal medicines to collect information. The survey was conducted from May 1, 2016 to March 31, 2017.

Results: The questionnaire response rate was 61% (99 companies responded). Eighty and 90 percent of the companies possessed information about the drug crushing methods and simple suspension methods used for administration of internal medicines,respectively. The type of information and examination methods used varied among the companies, was very limited, and was often limited to new drugs. The information acquisition rate about crushing methods was 69.3% in original examination methods of pharmaceutical companies. On the other hand, 90.3% of the information about simple suspension methods was obtained by the unified method of Hand Book of Simple Suspension Method.

Conclusions: In the future, medical practice and patients will benefit if examination methods to confirm the adequacy of crushing and administration through feeding tubes are commonly and consistently obtained by pharmaceutical companies. Furthermore, it would be very useful for information of crushing methods and simple suspension methods to be included in package inserts and interview forms.

Objective: In this study, pharmaceutical properties were compared between the original and generic ophthalmic solutions containing betamethasone.

Methods: The squeeze force, drop weight, surface tension, pH, kinematic viscosity, and total number of drops were measured. The drop volume was calculated from the drop weight and specific gravity. Information on preservatives contained in each product was collected from package inserts.

Results: There was a significant difference in the squeeze force between the original and generic drugs. The pH and kinematic viscosity did not differ between the drugs. The drop volume was in the range of 30.3 to 47.2 μL, and the surface tension ranged between 33.7 and 65.2 mN/N. The total number of drops was approximately 100 in the original drug, being the lowest.

Conclusion: The results of this study showed that the squeeze forces of all generic products but RINBETA PF, which was contained in a specific container, were smaller than that of the original product. The drop volumes of 2 generic products were ≥ 15-μL smaller than that of the original product, but they were within the permissible range. The maximum difference in the surface tension was approximately 33 mN/N, suggesting that drug solution relatively frequently overflows from the eyes. The total number of drops for all generic products was greater than that for the original product, suggesting that the former can be used at a higher frequency. Based on these results, pharmacists must select products in accordance with individual patients.

Objective: We evaluated patients’ degree of understanding of the effects and adverse drug reactions of SGLT2 inhibitors.

Methods: We targeted 26 patients who were administered SGLT2 inhibitors during hospitalizations between April 2017 and March 2018. The survey was conducted by interviewing the patients using a questionnaire.

Results: In total, 14 patients (53. 8%) were able to explain the term “efficacy.” Although 6 patients (23. 1%) understood “dehydration,” there was little understanding of “urinary tract infection” (7.7%) and “rash/erythema” (2 and 0 patients, respectively). In addition, we confirmed the details of the descriptions of adverse reactions caused by SGLT2 inhibitors with pharmacists, and found that 13 patients (50.0%) clearly received an explanation of “dehydration,” only 3 patients received an explanation of “urinary tract infection” (11.5%), and none of them comprehended “rash/erythema.” Overall, the patients’ awareness of the adverse drug reactions of SGLT2 inhibitors was low.

Conclusion: Unlike common drugs for diabetes, SGLT2 inhibitors have been attracting attention as protective agents of the heart and kidneys. Therefore, it is expected that prescriptions for SGLT2 will increase in the future. Pharmacists need to explain the effects and adverse drug reactions of SGLT2 inhibitors to the patients as well as make the patients understand the pharmacological mechanisms of action of SGLT2 inhibitors.