ABSTRACT
<b>Objective: </b>We conducted a questionnaire survey to comprehend the situation regarding the collection, provision, and utilization of drug safety information at hospitals. In addition, we asked pharmaceutical companies how they select medical institutions to provide drug safety information. We also investigated the current situation of information provision to Tokyo Medial Center by pharmaceutical companies.<br><b>Method: </b>A questionnaire was mailed to all hospitals in Japan. The survey was conducted between January 13 and February 10, 2011. Moreover, we asked thirteen pharmaceutical companies by telephone and e-mail about the implementation status of the provision of information and performed a survey at Tokyo Medical Center on the current situation of information provision by pharmaceutical companies regarding revisions to precaution sections in package inserts.<br><b>Results: </b>The results of the questionnaire survey (response rate: 41.2%) showed that the major information sources for hospitals were medical representatives (77.8%), Drug Safety Update (50.3%) and direct mails (49.3%). Furthermore, in the case of drugs prescribed exclusively for extramural dispensing, fewer hospitals responded that medical representatives of the pharmaceutical companies provided drug safety information and more hospitals responded that they did not obtain any drug safety information at all, compared with drugs listed in the hospital formularies.<br><b>Conclusion: </b>To minimize the risks of drugs, healthcare professionals must collect a wide range of drug safety information and must utilize this information in their medical practice. Therefore, it is important that pharmaceutical companies and regulatory authorities make an effort to provide suitable information dissemination to medical institutions. Furthermore, medical institutions must also strengthen their systems for collecting drug safety information and providing such information to healthcare professionals.
ABSTRACT
<b>Objective: </b>In the management of drug information, pharmacists are required to appropriately transmit information to the corresponding medical staff. However, it is unclear whether the transmitted information is received and utilized effectively. In this study, we assessed the effectiveness of drug safety information transmitted to doctors by pharmacists and investigated the requirements of doctors for the transmitted drug safety information in Okayama University Hospital.<br><b>Design and Methods: </b>We performed the assessment via questionnaire from doctors who had been sent drug safety information by electronic mail (e-mail) from January to October 2010. The return rate and responses for the questionnaire were investigated.<br><b>Results: </b>For the study time period, 15 cases of e-mail drug safety information transmissions occurred. The questionnaire was sent to 204 doctors, and the recovery rate of the questionnaire was 46.1%. Seventy-six percent of doctors who responded to the questionnaire answered that the e-mail information was useful for the clinical practice. Among the comments, it was noted that an improvement in the content of e-mail information would allow doctors to access the required information more conveniently.<br><b>Conclusion: </b>In this study, it was demonstrated that the majority of doctors were satisfied with the transmission of drug safety information using e-mail, although some improvement was needed. Furthermore, it was considered that the feedback assessment and re-construction of information transmittal system were important to improve usability and availability of the drug information service.
ABSTRACT
In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.<br>FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".<br>In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.
ABSTRACT
Objective : We studied the effective utilization of the community pharmacy-based prescription data for the event monitoring system in Japan, and attempted to evaluate the association between symptoms suspected of adverse drug reactions (ADRS) and the drug, inorder to improve the quality of ADR reports.<BR>Methods : 1) The community pharmacy-based prescription data obtained from 98 patients to whom medicines were dispensed in a community pharmacy, were examined to select subjects who had discontinued drug treatment and to evaluate outcome after the discontinuation.2) In the cases who discontinued treatment, risk information (for example, timing from the onset of therapyto the appearance of symptoms, outcome after discontinuation, relapses and disease states, etc....) was collected from the prescription data. The association between the specific symptoms and the suspected drug was evaluated using the algorithm of Kitaguchi et al. (IYAKUHIN KENKYU 1983; 14 : 980-992).3) Also, the 98 patients were screened for subjective symptoms by interview using an ADR check list, and the cases that complained of symptoms of suspected ADRS were selected.4) In the selected cases, risk information was collected by talking with the patients, and the association between symptoms and the suspected drug was evaluated by this algorithm.<BR>Results : 1) 16 cases with 26 symptoms had discontinued drug treatment. In these cases, the information related to the outcome after the drug discontinuation and disease states were obtained;not much information was available from the medication records. By using the algorithm, in 46% of the symptoms of these cases, the association between the symptoms and the drug was assessed as “possible”. Percentages of “definite”, “probable” and “remote” were 4%, 27% and 23%, respectively. 2) As a consequence of screening, 27 patients with 82 symptoms were suspected of ADRS. In these cases, there was little information related to timing, outcome and disease state. In fact, in half of the symptoms of these cases, the association between symptoms and the suspected drug could not be precisely determined.<BR>Conclusion : For the purpose of improvement in quality of ADR reports, community pharmacies need to develop a good relationship with health care agencies or providers to share clinical information and risk informations, as well as, to collect the time course information related to ADRS from the appearance of the symptoms to disappearance after drug discontinuation. The event monitoring system in Japan does not require causality evaluations for suspected ADRS now, however, the intention to effectively evaluate causality will improve the usefulness of ADR reports.