- 著者
- Takuro Okada Masahito Nakazaki Asami Funaki Mariko Kawana Masateru Ito Hirokazu Ishizuka Junko Nagai Atsushi Tanaka Ryokan Funakoshi Tadanori Sasaki
- 出版者
- Japanese Society of Drug Informatics
- 雑誌
- Iyakuhin Johogaku (ISSN:13451464)
- 巻号頁・発行日
- vol.19, no.3, pp.104-110, 2017 (Released:2017-12-27)
- 参考文献数
- 11
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.
- 著者
- Hyerim Park Akiko Miki Hiroki Satoh Yasufumi Sawada
- 出版者
- Japanese Society of Drug Informatics
- 雑誌
- Iyakuhin Johogaku (ISSN:13451464)
- 巻号頁・発行日
- vol.19, no.3, pp.133-141, 2017-11-30 (Released:2017-12-27)
- 参考文献数
- 19
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.
- 著者
- Yoshihiro Noguchi Ikuto Sugita Yuta Hayashi Aki Yoshida Anri Ueno Manami Ohtubo Hayato Katsuno Hiroki Esaki Kousuke Saito Tomoya Tachi Hitomi Teramachi
- 出版者
- Japanese Society of Drug Informatics
- 雑誌
- Iyakuhin Johogaku (ISSN:13451464)
- 巻号頁・発行日
- vol.19, no.3, pp.127-132, 2017 (Released:2017-12-27)
- 参考文献数
- 18
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.
- 著者
- Akiko Tanifuji Akira Nozaki Hiroo Makimoto Takeshi Hirano Midori Hirai
- 出版者
- Japanese Society of Drug Informatics
- 雑誌
- Iyakuhin Johogaku (ISSN:13451464)
- 巻号頁・発行日
- vol.19, no.2, pp.82-90, 2017 (Released:2017-09-07)
- 参考文献数
- 24
Objective: We aimed to integrate drug information (DI) documents universally necessary in most hospitals in Japan and share the DI documents nationwide. For this purpose, we planned to collect details (e.g., types of document, contents, sources of information used for preparing documents) regarding the DI documents prepared by the DI service section of each hospital.Methods: (1) Preliminary research: We searched Ichushi-Web (from January 1977 to December 2015) for cases in which DI documents were prepared by the DI service section of each hospital. (2) Questionnaire survey: We conducted the survey in DI section of 300 hospitals in Japan that were selected randomly. We asked the types of DI documents they have, sources of information used for preparing documents, and time needed for preparing documents.Results: (1) Forty titles, including those related to preoperative medication management, simple suspension methods of tablets, and list of dosing with renal impairment, were found. (2) In total, 148 hospitals (49.3%) responded to the survey. The main contents were as follows: preoperative medication management (130), the influence of a tube and a filter give to stability of injection medicine (67), list of high-risk medicines (54), suspension or porphyrization information on tablets (37), and others. The source of information used for preparing these documents was common in several hospitals.Conclusion: It was confirmed that similar DI documents are prepared by several DI sections of hospitals and some sources of drug information are common.