Objective: A simple suspension method in our previous study indicated that the amount of amlodipine recovered from a Norvasc®OD tablet was decreased by simultaneous suspension of a Magmitt®tablet containing magnesium oxide, due to the increase in pH.  However, it is still unclear whether this incompatibility arises in both brand name and generic tablets because the tablets may have different additives and mechanical properties.  In this study, we evaluated the degree of incompatibility between Magmitt®tablets and a range of amlodipine besylate tablets, including original and generic versions.
Methods: Twenty-four kinds of amlodipine besylate tablets were used.  Magmitt®and amlodipine besylate tablets were suspended in warm water (55°C), and 10 min or 2 h later, the amount of amlodipine in the suspension was measured by HPLC-UV.
Results: For almost all tested tablets, the recovery amount of amlodipine was significantly decreased in the presence of Magmitt®, and the amount recovered varied significantly between the types of amlodipine tablets.  However, Magmitt®tablet had little effect on the recovery of amlodipine from two specific brand tablets.
Conclusions: An incompatibility between Magmitt®and most types of amlodipine besylate could be observed, although the degree of incompatibility depended on the brand of amlodipine.  These results are useful for the proper use of drugs.

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Objective: Although generic drugs are considered bioequivalent to the original drugs, for formulations such as adhesive agents, the sensation during use (hereinafter, “sensation”) and handling characteristics (hereinafter, “handling”) are usually not investigated during the approval process.  Therefore, we established new drug evaluation criteria for transdermal adhesive agents, which included those relevant to handling and sensation, and investigated their usefulness.
Methods: This study assessed four test samples: the original loxoprofen sodium 100 mg tape (hereinafter, “LX-P 100 mg”) and three generic versions considered economically acceptable by our hospital.  The formulations were evaluated based on our criteria for generic drugs.  The handling and sensation were evaluated using a questionnaire with six parameters related to sensation and seven parameters related to handling.  The enrolled subjects comprised 20 pharmacists from our hospital.  Furthermore, a parallel evaluation using loxoprofen sodium 50 mg tape (hereinafter, “LX-P 50 mg”) was performed to explore the variance in the results of each individual criterion.
Results: The evaluation revealed differences between the formulations with regard to the thickness of the adhesive agent and stability after opening the package.  Various differences were observed by evaluation of the handling and sensation.  Based on the parameters used, the differences between the various formulations of LX-P 100 mg occurred in the following criteria: tactile sensation commensurate to the degree of adhesion; superficial resemblance to other agents; ease of adhesion; and ease of package opening.  For LX-P 50 mg, the differences were found in superficial resemblance to other agents and ease of liner removal.
Conclusion: Our newly established criteria for the evaluation of LX-P 100 mg revealed differences between the samples, which were used to identify products with poor handling and sensation.  Thus, this study successfully demonstrated the usefulness of the criteria for the purpose of medicine selection.

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Objective: There are prescription medicines with design-like (misunderstanding) bisection lines although these are not admitted as bisection lines according to dosage instructions.  We often find differences in identifying bisection lines among medical facilities in case of same tablets.  We conducted a survey about identifying bisection line-like design on tablets by pharmacists and investigated the reason for the discrepancy in identification among information service facilities.
Methods: We conducted an online survey for pharmacists at hospitals, clinics, and pharmacies.  We selected the discrepancies in identification among the facilities involved in drug information services.
Results: In this survey, 65.2% of pharmacists were aware of design-like bisection lines that are not permitted as bisection lines.  Further, 30.3% could not confirm if these were real bisection lines or design-like bisection lines by judging only from their surfaces.  The examination of two online media and a book offering drug information service showed different definitions depending on medicines.  These entities say they have obtained information by their own ways of source from pharmaceutical manufactures and sellers.
Conclusion: Even for pharmacists, it is difficult to distinguish actual bisection lines from design-like bisection lines.  The differences in identification among facilities dealing with medical information services are undesirable issues.  Regulations by GMP or other legal methods are required for appropriate information control by pharmaceutical manufacturers and sellers.

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Background: We report the results of the health check sheet survey on fexofenadine hydrochloride tablet (AllegraFX), conducted using a new health check sheet developed based on the results of the previously reported Loxonin(R)S survey.　In addition, we examined the utility of the health check sheet by comparing the results of the survey on AllegraFX with the post marketing surveillance (special survey) conducted by the pharmaceutical company manufacturing the drug.
Methods: The new health check sheet survey for AllegraFX was conducted in 41 pharmacies.　Efficacy, safety, and patient adherence were analyzed.
Results: The health check sheet survey for AllegraFX involved 190 purchasers, 143 (75.3%) of whom completed the second visit survey.　The efficacy rate for AllegraFX was 88.4% in the health check sheet survey.　Of the 16 symptoms reported over two cases in the special survey, 10 were also detected by the health check sheet survey.　Six symptoms were detected by the health check sheet survey but were not reported in the special survey.
Conclusion: Although conducted for a short survey period and in a small sample size, the health check sheet survey achieved results similar to the special survey in terms of identifying adverse events, indicating that a survey using the health check sheet can obtain results comparable to existing PMS protocols, with considerably lower labor.

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Objective: Gastrointestinal tract injury associated with non-steroidal anti-inflammatory drugs (NSAIDs) remains a clinically significant problem.  Therefore, evaluate using the signal detection that is also used clinically and report attention concerning the assessment of known adverse drug events.
Methods: In this study, we analyzed data on the serious adverse event gastrointestinal tract injury collected from 2004 to 2013 using Japanese Adverse Drug Event Report (JADER).  The indicated drugs were classified into 12 NSAIDs based on COX selectivity.
Results: In the usual analysis, several COX-1 selective NSAIDs were detected, but the signals of aspirin and the COX-2-selective NSAIDs etodolac and meloxicam associated with gastrointestinal tract injury were detected using ad hoc analysis.
Conclusion: Since the signal value is calculated from the data obtained from the spontaneous reporting system, it is influenced by the clinical use situation at the time of investigation.  Therefore, the signal value decreases if the risk, for which a countermeasure has been established, is high.  This result does not indicate that COX-1 selective NSAIDs are pharmacologically less risk of gastrointestinal tract injury than COX-2 selective NSAIDs.  There is a need to focus risk on emphasis on NSAIDs signal detected by ad hoc analysis.

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Objective: An aging population results in an increased number of people in need of long-term care.　Despite the role of care staff in supporting sufficient medication use, and medication risk management being important in long-term care, attitudes and concerns regarding medication assistance among nursing home staff are unclear.　The study aimed to survey fee-based elderly nursing homes staff attitudes and concerns about supporting medication use and drug information.
Methods: The questionnaire was designed to survey the attitudes, concerns, and knowledge of the support of residents' medication use by fee-based elderly nursing homes staff.　In August 2012, the questionnaire was distributed to 360 staff in 12 fee-based elderly nursing homes in Japan.
Results: A total of 201 responses (from 44 nursing staff and 157 care workers) were used in the analysis; 59.1% of nursing staff and 87.9% of care workers were anxious about the lack of basic medication knowledge, and 15.9% of nursing staff and 76.4% of care workers felt anxious that they could not answer residents' questions about medication.　Regarding the frequency of behaviors for obtaining drug information, few staff usually ask physicians (17.2%) or pharmacists (24.0%) for information.
Conclusion: Many fee-based elderly nursing homes staff were concerned about supporting medication use without knowledge of the medications that elderly residents are taking in fee-based elderly nursing homes.　The findings suggest that fee-based elderly nursing homes staff wanted to obtain basic drug information to support safe medication use.　It is important to relieve their concerns by providing basic education programs and strengthening collaboration with other health professionals to improve the quality of care involving medication.

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