Objective: Generic drugs similar in appearance to their brand-name counterparts have both advantages and disadvantages.  This study aimed to investigate patient preferences regarding the appearance of generic drugs.
Design: A cross-sectional survey.
Methods: We conducted a web-based survey between 2013 and 2014.  Patients aged ≥40 years who reported taking prescription drugs for >6 months were asked to provide their opinions on the appearance of generic drug formulations and press-through packages (PTPs).  Medical doctors and pharmacists were asked as to what type of appearance of generic drugs would be suitable as well as whether the appearance of these drugs and PTPs should be similar to that of their brand-name counterparts.
Results: A total of 911 patients, 238 pharmacists, and 81 medical doctors responded to the survey.  Most of the patients (45.3%) surveyed reported that the similarity in the appearance of generic drug formulations and PTPs to those of their brand-name counterparts was not important, whereas only 15.6% of patients preferred generic drug formulations and PTPs similar in appearance to their brand-name counterparts.  In contrast, most of the medical doctors (53.1%) and pharmacists (88.2%) reported that the appearance of generic drug formulations and PTPs should be similar to that of their brand-name counterparts.
Conclusion: Patients’ opinions on the appearance of generic drugs differ from what medical doctors and pharmacists perceive them to be.  Therefore, health care professionals should select generic drugs with an appearance as per the individual patient’s preference.

View full abstract

Objective: Pharmacists need to know at what positioning a drug is recommended in clinical practice guidelines when they make prescription proposals.  However, the format of guidelines and the definition of recommendation grades differ between academic societies, making it difficult to comprehensively extract only the information one needs.  Therefore, we developed a guideline utilization system to support prescription proposals by pharmacists.
Methods: We built a database comprised of clinical practice guidelines on pharmacological therapy for breast cancer and breast cancer-related conditions.  FileMaker®was used in the development of the system.
Result: This system allows the comprehensive extraction of clinical questions and recommendations from multiple guidelines by means of standardized keywords.
Conclusion: This system supports prescription proposals by pharmacists when generating pharmacological therapy protocols or when in discussions with healthcare professionals as information on the positioning of therapeutic agents in different guidelines and recommended drugs is readily available.

View full abstract

Objective: Owing to the recent advances in genetic analysis technology, its application in drug development is expected to increase, although there are concerns regarding the leakage of personal information.  This study aimed to assess the attitudes of community citizens toward genetic analysis studies associated with clinical trials planned by the pharmaceutical industry.
Methods: A questionnaire survey was conducted after an educational seminar on drug development at a university campus festival.  Answers were obtained from 47 citizens (16 males and 31 females, ages ranging from teens to fifties).
Results: Attitudes toward providing genome samples were assessed using a 100-mm visual analogue scale, and the data revealed significant differences in the conditions of sample use (A, limited to specific genes during the trial, 89±14 mm; B, limited to genes related to the test drug or target disease, 81±23 mm; C, unlimited, 71±33 mm, p<0.01).  Twenty-seven citizens (57%) consistently expressed acceptance toward all three conditions.  The remaining 38% (n=18) expressed denial as the analysis targets widened.  Regarding the acceptable period for sample storage, 17 citizens (36%) allowed “indefinite storage” but 14 citizens (30%) requested “immediate disposal after analysis.”  A feedback on the accidental findings of abnormalities was requested by 43 citizens (91%).
Conclusion: The results demonstrated a wide variety of attitudes toward providing samples.  On the other hand, most citizens requested a feedback on the findings of abnormalities for disease-related genes.  These results suggest that it is necessary to improve the study protocol to reflect these fears and expectations.

View full abstract

Objective: To clarify the actual situation about awareness of DI (the Drug Information in-charge) or information shared with the hospital including prescribing physician regarding the generics, which have added with other dosage innovators don’t have.
Methods: We did the questionnaire and analyzed awareness of DI, route of access to information, situation of transmission for the prescribing physician, and prescription regarding generics added with other dosage (Clopidogrel 50 mg, Quetiapine 12.5 mg, 50 mg, and Tacrolimus 1.5 mg, 3 mg).
Results: There were many cases that DI obtained the information regarding generics added with other dosage from MRs, magazine or website Web.  On the other hand, in case that conveys information about generics added with other dosage to the prescribing physician wasn’t so many.  And there were various reasons why the Drug Information in-charge didn’t inform to the prescribing physician.
Conclusion: Analysis of the valid responses was that more than two-thirds of DI recognized about generics added with other dosage of Clopidogrel and Quetiapine.  But share of recognition of DI was below 30% in case of Tacrolimus.  Also, share of transfer to the prescribing physician was about 15% in any case.  Main source of information about generics added with other dosage for DI was from MRs, magazine or website.  As the number of the companies which sell generics added with other dosage of Tacrolimus is few, we assumed that most of DI didn’t recognize it.  In addition, there were many comments which were judged that it isn’t necessary to transmit to the prescribing physician information generics added with other dosage in case of Clopidogrel and Quetiapine in the questionnaire.  On the other hand, though the number of sample was small compare to the case of Clopidogrel and Quetiapine, there was no comment that generics added with other dosage of Tacrolimus isn’t necessary.

View full abstract

Objective: We previously showed that interstitial lung disease, pneumonia, abnormal liver function, and anaphylactic reactions were frequent adverse events, and we analyzed outcomes, suspected causative drugs, and the onset of adverse events using information derived from the “Japanese Adverse Drug Event Report” (JADER) database.  Here, we aimed to determine the status of actual adverse reactions to carbamazepine (CBZ) and lamotrigine (LTG) using national public databases.
Methods: Data from the “Information on Decision on Payment/non-payment of Adverse Reaction Relief Benefits” (IARRB; April 2012-March 2016) and JADER (April 2012-March 2016) databases were downloaded from the website of the Pharmaceuticals and Medical Devices Agency.  Information from the national database of the “Health Insurance Claims and Specific Health Checkups of Japan” (NDB) (April 2014-March 2015) was downloaded from the website of the Ministry of Health, Labour and Welfare.
Results: The numbers of females and males in the IARRB were 169 and 229, respectively, for CBZ and 135 and 56, respectively, for LTG.  Those in JADER were 1,152 and 1,352, respectively, for CBZ and 1,358 and 806, respectively, for LTG.  The respective ratios of males and females prescribed CBZ and LTG in the NDB were 46.2 and 53.8%, and 56.3 and 43.7%, respectively.  Both CBZ and LTG were identified as very high-risk drugs associated with extreme skin reactions such as drug-induced hypersensitivity syndrome (DIHS), toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), erythema multiforme type drug eruption (EM), and disseminated papuloerythematous drug eruption (DPE).  CBZ induced DIHS, EM, and DPE more frequently among elderly men (over 60 years old), whereas LTG induced these reactions in women of reproductive age.
Conclusions: Elderly men prescribed CBZ and women of reproductive age prescribed LTG should be advised about extreme adverse skin reactions.

View full abstract

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.

View full abstract