Objective: In this study, we evaluated to examine the short-term educational effects for drug abuse prevention, including lectures and students’ awareness of drug abuse.
Method: A questionnaire consisting of eleven items and SD method-based image survey were conducted three times, prior to and following the lectures and after the summer vacation for first-year students of the Department of Pharmacy.
Results: The numbers of responses to the questionnaire surveys conducted prior to and following the summer vacation were 323 (response rate: 95.8%) and 332 (response rate: 97.9%), respectively.  When asked: “Do you think that people should be allowed to use cannabis (illegal herbal drugs) as long as they do not cause any trouble to others”, 2.8 (3.4) and 6.9 (6.6)% of students answered “Yes” after the lectures prior to the summer vacation and following it, respectively; there were both increased.  Following the summer vacation, 28.6% of students answered “Yes” to the question: “Have you ever seen or heard of people using cannabis or illegal herbal drugs ?”  A total of 2.1% of students had been “solicited to use cannabis or illegal herbal drugs”, and all of them stated that it would be “easy to obtain illegal herbal drugs”.  As the reason for drug abuse by young people, 140 students (42.2%) cited “curiosity”, and 81.6%, or 271 students, stated that they would “refuse” to use any illegal drugs even if they were asked to do so.  The results of the SD method-based image survey suggested significant changes in students’ awareness of drug abuse during the summer vacation; they had the image of little risk on drug abuse prevention following the vacation.
Conclusion: The effects of learning were not maintained in some first-year students because they faced a variety of temptations during the short summer vacation and their normative consciousness and images of drug abuse easily changed.  Therefore, it is necessary to provide lectures for new students to help them acquire accurate knowledge of drug abuse, enhance their normative consciousness, and increase their self-awareness as health care professionals, develop curriculums on a continuing basis, and deploy specialists so that students with psychological problems as identified by the survey, including stress, escapism, mental weakness, and anxiety, can consult them.

抄録全体を表示

Objective: There is enormous information flow via the Internet and papers.  Physicians require appropriate drug information from medical representatives (MRs), so fair promotion activities of MRs are necessary.  To clarify the activity and visiting aims of MRs, we investigated the visiting records for MRs.
Methods: We improved the visiting record form because there were some gaps in the records.  Subsequently, we investigated the validity of the records.  The correlations between visiting numbers of MRs and both purchase prices of our hospital and scale of drug companies were also investigated.  Two months after revision of the visiting records, a questionnaire survey was administered among MRs to determine their thoughts about promotion activities.
Results: The visiting numbers of MRs and companies did not change with revision of the visiting record.  Insufficient visiting records were significantly reduced from 5.1% to 0.8%.  There were no correlations between visiting numbers and purchase prices or scale of drug companies.  Meanwhile, sub-analysis of the visiting data indicated that MRs significantly promoted new drugs and drugs coming off patent.  The revision of visiting record format re-emphasized the importance of the visiting record on MRs.
Discussion: Almost all MRs promoted their products fairly, as there was no correlation between the purchase price and company scale.  However, they may actively promote new drugs and those with patents that have elapsed.  The visiting records are useful to determine the promotion activities of MRs.

抄録全体を表示

Objective: Recently, since usage of the kampo-medicines has changed from conventional usage, it is possible that the tendency of adverse reaction also changes.  Pharmaceuticals and Medical Devices Agency (PMDA) discloses information reported by Pharmaceuticals and Medical Devices Safety Information Reporting System.  In this study, we analyzed adverse drug events of kampo-medicines using Japanese Adverse Drug Event Report (JADER) database of PMDA.  We also investigated what adverse drug events are likely to be occurred by kampo-medicines and what kampo-medicine is likely to cause a particular adverse drug event.
Methods: We focused on reports referring to suspected drugs for kampo-medicines from JADER database of PMDA for about nine years from April 2004 to February 2013.  We analyzed kampo-medicines, organs, and adverse drug events based on the number of reports.
Results and Conclusion: We found 1,958 reports on adverse drug events for kampo-medicines.  The largest number of reports for kampo-medicines was on Shakuyakukanzoto, followed in order by Bofutsushosan, Saireito and Yokukansan.  The breakdown of each organ of adverse drug events reported was 34% for hepatobiliary system disorders, followed in order by 26% for respiratory, thoracic and mediastinal disorders, and 9% for metabolism and nutrition disorders.  A total of the above adverse drug events accounts for 70% of all adverse drug events.  The largest number of adverse drug events reported was 406 cases for interstitial lung disease, followed in order by 294 cases for liver disorder, 260 cases for hepatic dysfunction, 165 cases for hypokalemia, and 102 cases for pseudoaldosteronism.  There are many reports about pseudoaldosteronism of Yokukansan regardless of containing only 1.5 g ricorice per day.  As for cardiac disorders of Yokukansan, we need to pay attention to information in the future.

抄録全体を表示

Introduction: A health assessment sheet was developed to establish a new method for post marketing surveillance (PMS) for nonprescription drugs, the status of which has recently been switched from prescription (Rx) to over-the-counter (OTC) to confirm the efficacy and safety of Rx-to-OTC switched drugs.  The assessment sheet was designed to evaluate adverse reactions that may be possibly induced by the drugs and to elicit spontaneous complaints from consumers.  An investigation using the assessment sheet had been conducted earlier for famotidine tablets.  While the earlier investigation suggested the effectiveness of the assessment method, it also revealed some issues.  After making improvements in the assessment sheet, another investigation was conducted for Loxonin®S.
Method: Purchasers of Loxonin®S were asked to tick symptoms that were applicable to them among those listed in the sheet.  They were asked to revisit the pharmacy and complete the sheet for the second time after drug administration.  The possibility of adverse reactions was considered for the symptoms additionally chosen at the second visit and they were then compared with the adverse reactions described in the package insert of Loxonin®S.
Results: Total 284 people completed the health assessment sheet at their first and second visits.  Of them, 44 people (15.5%) reported additional symptoms at the second visit.  Commonly reported symptom was “frequent experience of sleepiness,” “persistent headaches” and “fatigability.”
Conclusion: The study suggested that the health assessment sheet can be an effective tool for PMS for nonprescription drugs immediately after the Rx-to-OTC switch and contributes to detecting adverse reactions of the drugs.

抄録全体を表示

Objective: For safe use of drugs, it is indispensable to carry out proper and continuous risk management throughout preclinical to post-marketing phases.  In Japan, denosumab, a novel anti-RANKL antibody for treatment of bone metastasis, was approved in April 2012.  Since beginning of clinical use, severe hypocalcemia has been reported as adverse drug reactions.  In this study, the role of pharmacists in minimization of risks of newly introduced drugs was examined using denosumab as an example.
Methods: Firstly, the description on prevention of hypocalcemia in approval review report and different versions of drug package inserts of denosumab were compared.  Secondly, the differences in ratio of hypocalcemia in patients using denosumab with or without concomitant use of Ca and vitamin D preparations in Kobe City Medical Center General Hospital between April 2012 and July 2013 were examined.
Results: During the few months after beginning of clinical use of denosumab, many cases on the onset of severe hypocalcemia induced by denosumab had been reported.  Therefore, drug package insert was revised to enhance and recommend Ca and vitamin D supplementation.  Before the in-house enforcement in our hospital, of 26 patients, 6 patients were administered with denosumab without Ca and vitamin D preparations and 2 of them developed hypocalcemia over Grade 3.  After the in-house enforcement, no significant changed in serum Ca level in the 20 patients with Ca and vitamin D preparations were observed.
Discussion: Severe side effects can be avoided if hospital pharmacists take appropriate measures based on rational evaluation of proper information.
Conclusions: For risk minimization, pharmacists must evaluate and manage the risks of newly introduced drugs.

抄録全体を表示