Objective: Instructions contained in over-the-counter medicine package inserts can be hard to read because of the limited printing space.  Pictograms are one means of helping users to understand important information.  However, few pictogram systems have been reliably and validly evaluated.  Therefore, a new method was developed to improve the clarity of each illustration and the legitimacy as a pictogram for conveying information important.
Methods: Four creators developed 69 illustrations, each of which expressed one of 24 instructions in the package insert of an H2 blocker.  In a survey, participants (449 university undergraduate and graduate students and 103 pharmacy users) were asked to describe the possible meaning of each illustration and to provide their personal suggestions for improvement.  To evaluate comprehension of information, each instruction was broken into two or three different parts.  Comprehension level was calculated by: (number of people who answered correctly) × 100 / (total number of respondents).  Existing pictograms were included to compare comprehension levels for the same instructions.
Results: Using 67% as the minimum standard for comprehension, we classified each illustration into one of three categories: “no need for improvement,” “need for partial improvement,” and “need for total improvement.”  The students and pharmacy users tended to accurately interpret the possible meanings of illustrations that were familiar to them.
Conclusion: Breaking one instruction of the package insert into a few important pieces of information was useful for determining the level of improvement needed for each illustration.  Evaluating how well each illustration conveys important information in the instructions through two steps was also beneficial, which are to improve the illustration’s clarity with students and its legitimacy among pharmacy users for fulfilling the intended functions of a pictogram.

View full abstract

Objective: Celecoxib has been reported to enhance the action of warfarin by inhibiting CYP2C9, its major hepatic drug-metabolizing enzyme, but sufficient information about the mechanism has not been obtained, especially in Japan.
Methods: A study was conducted to investigate the prothrombin time international normalized ratio (PT-INR) and the warfarin sensitivity index (WSI) before and after concurrent administration of celecoxib, as well as the Drug Interaction Probability Scale (DIPS) scores to determine causality with drug interactions, in patients commencing concurrent therapy with celecoxib and warfarin at Kanagawa Prefectural Keiyukai Keiyu Hospital during the 4-year period from October 2011 to September 2015.
Results: Analysis of 18 patients showed that the PT-INR increased significantly from 1.53±0.43 before concurrent therapy to 2.18±1.01 after concurrent therapy (p=0.0101).  The WSI also increased significantly from 0.76±0.50 before concurrent therapy to 1.01±0.65 after concurrent therapy (p=0.0044).  According to the DIPS scores, the causal relation was not rated as “Highly Probable” in any of the patients, while it was considered to be “Probable” in 3 patients, “Possible” in 10 patients, and “Doubtful” in 5 patients.
Conclusion: The findings of this study suggested that when celecoxib treatment is initiated in patients who are already taking warfarin, attention must be paid to changes of coagulation profile, especially in elderly patients.

View full abstract

Objective: For effective use of over-the-counter (OTC) drugs that are provided as relief supplies during a disaster, we aimed to develop a list of OTC drugs that can be used during a disaster.
Methods: We obtained information about OTC drugs useful during a disaster by examining results of previous studies and lists of drugs used during a disaster.  We analyzed this information with the expert pharmacist of disaster support and established a rationale for our list and developed “the List of Useful OTC Drugs During a Disaster” and “the Information Card on Useful OTC Drugs During a Disaster.”
Results: We developed our list of OTC drugs based on the following parameters: (1) while people with severe disorders (e.g. renal failure) are treated by medical teams, those with minor physical conditions are treated using OTC drugs and (2) those OTC drugs that can be used as substitutes for prescription drugs were preferably selected.  The List of Useful OTC Drugs ()—During a Disaster (containing 56 items) was developed for use mainly by medical professionals.  Further, pharmacists from disaster-relief medical teams may not always be available in disaster-stricken areas; therefore, the Information Card on Useful OTC Drugs During a Disaster was developed to enable disaster victims to independently make a certain level of decision.  The information card contained pictograms to call the attention of the disaster victims.
Conclusion: Our results can provide a common tool for drug suppliers, medical professionals engaging in relief works in disaster-stricken areas, and disaster victims.

View full abstract

Objective: As a “family pharmacy and pharmacist,” high-quality medical service is demanded.  Many patient satisfaction investigations are performed to evaluate community pharmacies, but it has been impossible until now to do so using an improvement index of the medical quality.  Therefore, I investigated the influence and evaluation structure of two evaluation concepts regarding quality of medical service and patient satisfaction and intention to use again, which becomes the important key as a “family” pharmacy.
Methods: I used anonymous patient survey data gathered for the purpose of duties improvement in July 2009.  I subjected the responses to factor and covariance structure analyses.
Results: Dates for four dimensions were obtained for factor analysis.  As a whole, covariance structure analysis showed that, in terms of privacy and only for service quality, entertainment primarily influenced satisfaction.  The ingestion instruction had a big effect on both sides.  General satisfaction was also substantially influenced by service quality.  The difference in influence degree was confirmed at each parameter.
Conclusion: It was found that not only satisfaction but also quality of service were equally demanded in community pharmacies.  It is necessary to increase these because most are influenced by ingestion instruction as a factor in service quality.  However, future investigation is necessary to clarify the detailed ingestion instruction contents.

View full abstract

Purpose: The purpose of this study is to elucidate the characteristics of adverse events in pregnant women, the offending drugs, and patient backgrounds from reports of adverse events.  We performed a case series study.
Methods: We used CARPIS, a database of adverse events and toxication reported in Japan spanning from 1987 to 2014 and created by the Drug Information Center, Meijo University.  We extracted cases of adverse events in pregnant women, their fetuses, and newborns and investigated the age, primary disease, and history of allergies of the women and the intended use of/offending drugs, therapeutic category, and names for adverse events.
Result: We collected 434 cases of adverse events in pregnant women, and 251 pediatric cases with adverse events.  The most frequent offending drug in both groups was ritodrine hydrochloride.  The most frequent adverse event in pregnant women was pulmonary oedema due to the administration of ritodrine hydrochloride.  The most frequently reported adverse events in pediatric cases were transient hypothyroidism and withdrawal symptoms in newborns and birth abnormalities in fetuses and newborns, all of which were caused by drugs given for the underlying diseases of their mothers.
Discussion: We elucidated serious adverse events in pregnant women caused by the administration of ritodrine hydrochloride.  Frequent factors for adverse events were the onset of physiological factors in pregnant women and complicated factors of the mechanism of action of ritodrine hydrochloride.  We need to monitor both mothers and fetuses during the drug administration.  It is suggested that adverse events in pediatric cases are associated with drugs given for underlying diseases in mothers.  Thus, it is necessary to give appropriate information and communicate the risks of taking these drugs before pregnancy.  We believe the results could be helpful in the early detection of adverse events in the future.

View full abstract

Objective: Finger-tip unit (FTU) has been used in Western countries to apply a specific amount of steroid ointment available in tube form.  Although prescription ointments for treating skin disorders are available in Japan, there are no indications for patients regarding the amount to be used.  Therefore, we investigated the factual assessment of patient compliance instructions on using the ointments given by pharmacists and conducted a comparative test on the amount of ointment in 1 FTU using commercially available ointment tube products.
Methods: We conducted a questionnaire survey for 21 hospital pharmacists on patient compliance instructions for ointments.  Using six types of ointments, we measured the aperture area of ointment tube, weight of 1 FTU and squeezing number of tube.
Results: Fewer than 50% of pharmacists explained the application methods and amounts for one-time use when they provided patient compliance instructions.  There were many patients who used an ointment inadequately.  The most were problems about the quantity of application.  Wide variations were found among the amount of ointment in 1 FTU weight and number of available uses.
Conclusion: The survey results demonstrated that the methods used to apply the ointments are items that must also be emphasized by pharmacists when providing patients compliance instructions.  Furthermore, the patient compliance instructions should include the amount of ointment in 1 FTU and number of available uses within pharmaceutical products.

View full abstract

Objective: Elderly patients commonly experience adverse drug events (ADEs) owing to their poor drug metabolizing and excretion ability, and these often cause multiple organ dysfunction syndrome.  Therefore, it is important that we identify the adverse drug events early on during prognosis.  We searched for oral medicines that might exacerbate the prognosis of ADEs in elderly patients.
Methods: The objects under analysis were oral medicines that were registered in the Japanese Adverse Drug Event Report database (JADER).  The associations between the elderly/non-elderly patients and exacerbation risk/non-exacerbation risk were analyzed by risk ratios (RR).  The signal detection of exacerbation risk was defined as 95% confidence interval of lower limit of risk ratio>1 and χ²≥4.
Results: The oral medicines that might markedly exacerbate the prognosis of ADEs in the elderly patients in comparison with the ADEs of young patients included 84 items, of which 63 have not been described as potentially inappropriate medicines in all guidelines for medical treatment of the elderly patients.
Conclusion: In this study, while we could not search for oral medicines having a high risk of ADEs, we were able to search for oral medicines that might exacerbate the prognosis of ADEs in elderly patients.  This result could contribute to the proper use of medicines in the elderly patients.

View full abstract

Objective: In Japan, the healthcare authority encourages physicians to prescribe generic drugs in order to reduce the copayments by the patients for pharmaceutical expenses and to improve the financial status of the national medical insurance system.  In accordance with this governmental policy, we have been actively involved in switching original to generic formulations.  Thus, Utemerine® 50 mg injection was replaced with Ritodrine hydrochloride 50 mg intravenous injection produced by Nichiiko.  There have been some reports on adverse events caused by the generic formulations of Ritodrine hydrochloride.  Factors contributing to these adverse effects may include different additives and/or vehicles and the exemption of demonstrating some conditions for approval, including clinical trials.  Therefore, in order to assess the efficacy and safety of a generic formulation of Ritodrine hydrochloride injection formulation compared with the original formulation and to decide on its continued use, we carried out a retrospective cohort study.
Methods: We carried out a retrospective cohort study in order to assess the efficacy and safety of a generic formulation of Ritodrine hydrochloride injection formulation compared with the original formulation.
Results: There were no significant differences in the length of hospital stay, rate of emergency transport to other institutions, gestational week of delivery, rate of stillbirth, rate of abortion, or incidence of adverse events between the two formulations.
Conclusion: Our results may contribute to the safe and secure use of the generic formulations of Ritodrine hydrochloride in the current situation of the increasing use of generic drugs in health care.  Although there are some limitations in our study, the results suggest that there are no particular problems with the continued use of Ritodrine hydrochloride 50 mg intravenous injection produced by Nichiiko.

View full abstract

Objective: We conducted a meta-analysis on the suppressive effect of resistant maltodextrin on post-prandial blood glucose elevation, which is approved in Japan as food for specified health use, and the following is allowed to be indicated on the label “it is suitable for consumption by those who are concerned about their post-prandial blood glucose levels because the absorption of sugars is abated by the action of dietary fiber (resistant maltodextrin).”
Method: Our literature search covered Ichushi-Web (Japan Medical Abstracts Society), Japan Science and Technology Information Aggregator, Electronic (J-stage), Google Scholar, and PubMed databases and extracted English and Japanese publications on randomized, double-blind, controlled studies comparing resistant maltodextrin and a control in Japanese subjects for the reduction of areas under the blood glucose response curves at 30, 60, and 120 min after eating as an efficacy index.
Result: Among these publications, four articles with a Jadad score (an assessment of the quality of randomized controlled studies) of ≥ 3 were included in the meta-analysis.  Significant inhibitory effects were confirmed from areas under the blood glucose response curves at 30, 60, and 120 min after eating in the meta-analysis that was performed to evaluate the effects of resistant maltodextrin on post-prandial blood glucose elevation in Japanese individuals.
Conclusion: However, we were not able to test for publication bias because the number of extracted publications was small, and thus, additional research and case studies are warranted.

View full abstract

Objective: The dispensing fee revision of April in 2016 made a review of the assessment of inquiries about prescriptions.  The requirement was added by articles that seemed to be pharmaceutically necessary, showing an increase of responsibility for pharmacists.  Based on this, we performed a discussion while collecting the cases of inquiries about prescriptions.
Method: Among the inquiries about prescriptions performed at Jinjo Pharmacy for 4 months starting from April in 2016, we selected 83 cases where a prescription was changed by the pharmacist’s recommendation, based on pharmaceutical information such as drug duplication or drug interaction and confirmation of leftover medicine.  Then, we compared them with the study of inquiries about prescriptions performed by the Japan Pharmaceutical Association in 2015.
Result/Consideration: Inquiries about dose were the leading content, followed by those about duplication with other drugs of same indications and appropriateness of dose considering the adjustment of number of days due to residual drug, which showed the importance of medicinal history and prescription records.  It is considered necessary to renew the contents of the prescription record properly, based on the information acquired, while at the same time changing the pharmaceutical history based on those records.  It is thought that an inquiry about prescriptions will be performed appropriately by making a judgment based on such information. In order to do that, updated knowledge about medicine and updated information about drugs is necessary.  In comparison of the two studies, both showed that the drug information on “safety” and “dose and dose regimen” accounted for a large part of inquiries.  Further consideration on them will be necessary.

View full abstract