[Practical Use Evaluation of Aluminum Packaging for Medicinal Products Based on Universal Design].

Many pharmacists have requested optimization of aluminum packaging of medicinal products in terms of usability. To improve operational efficiency of aluminum packaging, we used Universal Design (UD)-based approach, which enables products to be used properly and consistently regardless of users. The UD-pack used in this research is composed of a film that can be easily opened and torn linear. Here, we compared the UD-pack to conventional aluminum packaging by evaluating the practical use of each under the cooperation of 24 pharmacists. Following opening and removal of contents of one sample for both types of packaging, monitors were asked which type was easier to use in each case. Also, monitors were to repeat the opening and removal of contents of five samples in a row, and were asked the same question. Monitors were recorded by digital camera to measure the time required to finish the procedure for five samples in a row. After opening one sample, approximately 83% of monitors preferred the UD-pack, and after opening five samples, all (100%) preferred the UD-pack. Regarding the time required for opening five samples and removing the contents measured by analyzing the recorded video, the UD-pack significantly reduced the time required for all monitors. The average time ratio of the UD-pack to conventional aluminum packaging was approximately 59%, and no significant difference was observed between male and female pharmacists. Our results indicate the UD-pack improves ease of opening and removal of contents and increases efficiency of dispensing in a clinical setting compared with conventional aluminum packaging.

[A research of letter color visibility in package insert information using simulator].

Package insert of pharmaceutical drug is one of the most prioritized information for pharmacists to secure safety of patients. However, the color of character, size, font and so on are various company by company product to product from a viewpoint of visibility. It may be cause a serious accident in case visibility is unclear, although it is the most important information. Moreover, package insert with high visibility is required for color vision defectives from a viewpoint of a universal design. Then, the authors selected the package insert which has the boxed warning in the ethical pharmaceutical currently stored mostly in the present health insurance pharmacy and quantified the red color using the color meter. We advocate the state of a suitable package insert from a viewpoint of a universal design, whether the red color is high visible or not for color vision defectives using simulator.

[Medical economics research on awareness of community pharmacists about raising pharmaceutical questions regarding prescriptions issued by physicians].

This study examined the impact of pharmaceutical inquiries regarding prescriptions on drug costs by surveying the actual condition of inquiries at 13 pharmacies. The study also investigated the significance of inquiries from a medical economics perspective by calculating the medical cost savings realized by preventing adverse drug reactions (ADRs). As a result, the total change in drug costs for the 13 pharmacies after pharmaceutical inquiries represented an increase of ¥9,018/month. However, upon recalculating the cost of drugs by assuming that those with an "Incomplete entry in the prescription (compared with previous prescription, etc.)" should in fact have been prescribed, and excluding them, the total drug costs for the 13 pharmacies is decreased to ¥154,743/month, translating to a cost-savings of ¥7.2/prescription. The study then undertook a comprehensive assessment based on the Diagnosis Procedure Combination (DPC) system to determine the total medical cost-savings for 5 patients in whom ADRs could have occurred if the prescriptions had not been modified as a result of pharmaceutical inquiries. The obtained figure of ¥1,188,830 suggests that pharmaceutical inquiries contribute to reduced medical costs. The findings of this study indicate that pharmaceutical inquiries regarding prescriptions by staff pharmacists not only ensure the proper delivery of drug therapy to patients, but are also effective from a medical economics perspective.

[Survey on the awareness of community pharmacists about raising pharmaceutical questions regarding prescriptions issued by physicians].

Community pharmacists can provide effective pharmaceutical care by questioning the physicians about their prescriptions. The regulatory authority (Ministry of Health, Labour and Welfare or the like) has been issuing instructions/advice to health insurance-covered pharmacies about the nature of questions to be asked to physicians under the national health insurance system. However, this practice has been facing similar kind of problems almost every year. To identify the reasons for repetition of the problems and facilitate proper application of drug therapy at hospitals, we recently examined the nature of questions asked to physicians by conducting a survey of 165 health insurance-covered pharmacies belonging to 8 district branches of the Japan Pharmaceutical Association. When the pharmacists were asked to express their view whether each of the 18 sample questions included in the past surveys was actually necessary, the most frequent answer from the respondents (n=1980) was "neutral" (42.9%), followed by "unnecessary" (29.0%) and "necessary" (26.6%). Further, 55.5% respondents answered that it is necessary to refer to publications of the concerned fields (guidelines, etc.) when questioning the prescriptions. However, the responses about the possible reasons for judging the necessity of the questions suggested that sometimes the pharmacists failed to understand the details of such publications. The results from this study suggest that a high percentage of community pharmacists believed that there was little need to ask questions about prescriptions if the suggestions made by the regulatory authority about the relevant questions were taken into account. Further, our study findings suggested that pharmacists working at clinics cannot present a clear-cut rationale for their judgment about the necessity of asking questions about prescriptions under the current circumstances where sufficient information collection and the evaluation of need for asking questions about prescriptions are not possible.

[Survey of difference in appearance between multiple-specifications press-through-package drug products and an attempt to evaluate their effectiveness based on dispensing incidents].

To survey the difference in appearance between multiple-specification press-through-package (PTP) drug products and to attempt to evaluate their effectiveness as discriminating factors based on dispensing incidents. Front and back sides of, respectively, 153 and 134 PTP drug products of multiple specifications stockpiled in the author's pharmacy were surveyed for differences in wording and appearance between specifications of the same type of drug. Fifty six dispensing incidents with 40 sets occurred over a year and they were analyzed for the appearance similarity of the front side. The difference factors detected in the 40 sets of "mix-ups" were also reviewed after similarity-omitted counting. We identified six factors with difference in appearance: color-related (letter front or patterns, sheet, medicine) and shape- or pattern-related details (sheet and medicine sizes, patterns). Multiple differences on the front packaging of the same type of drug were identified in 93% of the sets, while only one difference was found in about half of the sets on the back, indicating that pharmaceutical companies placed more emphasis on the front side to discriminate their features. When reviewed by similarity-omitted counting, the ratio of sets with only one difference in the 40 mix-ups was higher than those to 128 sets of non-mix-ups, the total sets except the mix-ups, while the ratio of sets with two differences was lower. In addition, the ratio of sets in which only color-related factors differed in the 40 mix-ups was higher than that in the corresponding category to the 128 sets of non-mix-ups. Various discriminating factors were used in combination on the front side of multiple-specification PTP drug products. A combined use of shape- or pattern-related and color-related factors probably reduces dispensing incidents among products with multiple specifications. However, further accumulation of incident data and multifactor analysis of those data seem necessary to clarify the function of difference in appearance in dispensing incidents.

[Simple method for precognition of drug interaction between oral iron and phenolic hydroxyl group-containing drugs].

In the present study, we devised a simple method for detecting the drug interaction between oral iron preparations and phenolic hydroxyl group-containing drugs, using the coloring reaction as indicator, due to the formation of complexes or chelates. In the method, oral iron preparations and test drugs in amounts as much as single dose for adults were added to 10 ml of purified water to make sample suspensions for testing. Thirty minutes after mixing an oral iron suspension and a test drug suspension, the change of color in the mixture was observed macroscopically and graded as 0 to 3, with a marked color change judged as grade 3 and no color change as grade 0. Screening of 14 test drugs commonly used orally was carried out. When using sodium ferrous citrate preparations as oral iron, 5 were classified as grade 3, 2 as grade 2, 4 as grade 1, and 3 as grade 0, respectively. To verify usefulness of the method, the interactions suggested by screening were pharmacokinetically assessed by measuring serum concentrations of the drug in mice. When a levodopa or droxidopa preparation, judged as grade 3 in screening, was concomitantly administered with an iron preparation, a significant reduction in bioavailability of the test drug was observed, indicating possible drug interaction between the test drug and oral iron. Combined administration of an acetaminophen preparation, judged as grade 1, and oral iron preparation showed no influence on the bioavailability of the test drug, implying no detectable interactions between them. In conclusion, the simple method devised in the present study is useful for precognition of drug interactions between oral iron preparations and phenolic hydroxyl group-containing drugs, and the drugs with a higher grade in screening may induce drug interactions with oral iron.

Optimal impedance control for task achievement in the presence of signal-dependent noise.

There is an infinity of impedance parameter values, and thus different co-contraction levels, that can produce similar movement kinematics from which the CNS must select one. Although signal-dependent noise (SDN) predicts larger motor-command variability during higher co-contraction, the relationship between impedance and task performance is not theoretically obvious and thus was examined here. Subjects made goal-directed, single-joint elbow movements to either move naturally to different target sizes or voluntarily co-contract at different levels. Stiffness was estimated as the weighted summation of rectified EMG signals through the index of muscle co-contraction around the joint (IMCJ) proposed previously. When subjects made movements to targets of different sizes, IMCJ increased with the accuracy requirements, leading to reduced endpoint deviations. Therefore without the need for great accuracy, subjects accepted worse performance with lower co-contraction. When subjects were asked to increase co-contraction, the variability of EMG and torque both increased, suggesting that noise in the neuromotor command increased with muscle activation. In contrast, the final positional error was smallest for the highest IMCJ level. Although co-contraction increases the motor-command noise, the effect of this noise on the task performance is reduced. Subjects were able to regulate their impedance and control endpoint variance as the task requirements changed, and they did not voluntarily select the high impedance that generated the minimum endpoint error. These data contradict predictions of the SDN-based theory, which postulates minimization of only endpoint variance and thus require its revision.