Pharmacy practice experiences (PPEs) based on a revised model core curriculum for pharmaceutical education that incorporates outcome-based education have been implemented in Japan. PPEs is a 22-week period in both a community pharmacy and hospital and is characterized by “participatory and experiential learning,” “performance evaluation,” and “continuous involvement in eight representative diseases.” This mini-review describes the evaluation from preintroduction to implementation of PPEs. During the performance evaluation, using a rubric—consisting of a four-point score—for assessing pharmaceutical students’ performance instead of a rating scale of specific behavioral objectives was feasible. Pharmacist mentors and pharmaceutical students could measure the latter’s performance level and growth in PPEs at a community pharmacy or hospital using a rubric assessment. During the continuous involvement of eight representative diseases, sharing information tools between community pharmacies and hospitals substantially increased the implementation rate related to these eight diseases. Furthermore, experiences of eight representative diseases were considerably associated with the growth of pharmaceutical students’ performance. Results indicate that PPEs with which pharmaceutical students experience a wide range of involvement with eight representative diseases may effectively enhance their competencies.
LM1010 high-performance liquid chromatography system was recently approved as a medical diagnostic device. Phenytoin and carbamazepine—the antiepileptic drugs—can be detected simultaneously using LM1010; however, the accuracy of quantification of these two drugs in serum using this system has not been established. Herein, we compared the performance of LM1010 in measuring phenytoin and carbamazepine with that of an established chemiluminescent immunoassay (CLIA)using the ARCHITECT system. When CLIA calibrator samples were examined using both methods, the accuracy of LM1010 was within 3.20% for phenytoin and 6.50% for carbamazepine. Moreover, the two methods were applied to serum samples from subjects taking phenytoin (n = 95)or carbamazepine (n = 69). The slopes of Deming regression curves comparing LM1010 to CLIA for phenytoin and carbamazepine were 0.984 and 0.943, respectively. Further, Bland–Altman analyses showed an average positive bias (±1.96 × SD)of 0.180 (−1.998 – 2.359)μg/mL for phenytoin and 0.001 (−1.171 – 1.174)μg/mL for carbamazepine using LM1010 relative to CLIA. There were strong correlations between results from LM1010 and CLIA for serum phenytoin and carbamazepine (Spearman’s r = 0.9836 and 0.9754, respectively). The difference in the measurements of serum concentrations of carbamazepine was partially yet significantly negatively correlated with serum hemoglobin (slope = −0.1094). Thus, we successfully applied LM1010 to the simultaneous determination of serum concentrations of phenytoin and carbamazepine and concluded that this system can be used for routine therapeutic drug monitoring.
Patients of different age groups have difficulty taking medications. Using the Japanese version of the PILL-5 assessment tool (PILL-5), we investigated patients with pill dysphagia and the degree of improvement with deglutition aids. Moreover, we investigated the factors, such as the position of the jaw, sex, and choking on water, associated with pill dysphagia.
A total of 586 patients from 10 hospitals and 6 pharmacies aged 18 – 85 years, who were on regular self-administered medications and ate regularly, were included in the study. Out of 17 patients (2.9%) with pill dysphagia who had a total score ≥ 6, 6 showed considerable improvement in their PILL-5 total score and throat and chest tightness using deglutition aids. Notably, 81 patients (13.8%) with potential pill dysphagia had a PILL-5 score ≥ 2 for any one of the five items. Patients with pill dysphagia and potential pill dysphagia highly related with choking while taking pills (OR = 9.45, P < 0.001). Factors associated with patients having choking were < 65 years old (OR = 1.93, P = 0.031) and jaw position upward (OR = 2.31, P = 0.013).
Patients with pill dysphagia, and those with potential pill dysphagia identified as choking on water while taking medicines and the position of their jaws. Therefore, supporting pill dysphagia at an early stage is necessary.
Folic acid supplementation is essential during pregnancy to mitigate the risk of neural tube defects in the fetus. Moreover, folic acid supplements are often necessary to meet the recommended Folic Acid dosage during pregnancy. Although these supplements are classified as food products, information on their quality is lacking. Therefore, this study assessed the quality of folic acid supplements. According to the Japanese Pharmacopoeia guidelines, seven over-the-counter folic acid supplements were subjected to various tests, such as mass variation, dissolution, content measurement, and disintegration tests, and compared with available medical folic acid tablets. Content measurement tests revealed that the folic acid content of the three folic acid supplements were below the lower limit of the acceptable range for Nutritional Ingredient Labeling Standards, which is stipulated by Consumer Affairs Agency. Furthermore, one and four supplements during the disintegration and dissolution tests failed to meet the Japanese Pharmacopoeia standards, suggesting that some folic acid supplements did not properly dissolve and disintegrate, even under conditions similar to those in the digestive tract, which is typically targeted by medical folic acid tablets. In the present scenario, in which folic acid intake during pregnancy is dependent on dietary supplements, providing information that allows consumers to select products of assured quality is necessary.
Neuropathy, visual impairment, and hepatic dysfunction are common adverse events in voriconazole therapy. Therapeutic drug monitoring (TDM) is useful for improving treatment efficacy and preventing drug-related adverse events. This study was designed to prospectively examine the relationship between adverse events and drug plasma concentrations that occur early during treatment in patients receiving regular oral voriconazole. Patients kept a diary of their medication and blood collection times, neurological symptoms, and visual symptoms. Plasma concentrations of VRCZ were measured on days 4 and 7 after administration of VRCZ in hospitalized patients (26 patients) who received a loading dose of VRCZ at our hospital. The incidence of neurological, visual, and hepatic dysfunction was 34.6%, 50.0%, and 26.9%, respectively. The median timing and duration of adverse events were neuropathy after 3 and 5 days, visual impairment after 1 and 3 days, and hepatic dysfunction after 9 and 5 days. The mean VRCZ plasma concentrations in patients with adverse events were considerably higher than those in patients without adverse events. The cutoff values of VRCZ plasma concentration for predicting adverse events were 4.02, 3.61, and 5.14 µg/mL for neuropathy, visual impairment, and liver dysfunction, respectively. In addition, half of the patients spontaneously recovered from adverse events, whereas others recovered with dose reductions. These results indicate that early TDM intervention (VRCZ plasma concentration: < 4 µg/mL) on days 4 and 7 of oral VRCZ administration is expected to contribute to early recovery from early adverse events and to avoid severe events.
Dantrium® capsules 25 mg are often used for patients with spastic paraplegia, and patients who have difficulty swallowing or need to be fed through a feeding tube are instructed to dispense the capsule in powder form. Decapsulation by manual removal is time-consuming and involves strain dispensing. In addition, tablet crushers are at risk of tube blockage owing to the capsule shells. Herein, we investigated rapid decapsulation of capsules without shells and reported a simple decapsulation method using a planetary centrifugal mixer.
Hundred capsules with indentations made in both hemispheres of the capsule formulation using a pestle were crushed at 1,200 rpm for 30 s using a mixer, and the capsule contents were manually sieved. The weight difference between the capsule contents and lactose excipient–added dispersions were evaluated. As a result, for 100 capsules, comparisons showed manual removal times of 19 min and 29 s versus 5 min and 26 s for the mixer, with yields of 99.3% and 96.3%, respectively. In addition, only 0.26% of the capsule shell was contained in the powder. The coefficient of variation of the weight deviation was < 6.1%, which meets the criteria of the dispensing guidelines. However, the total mass loss met the standard for excipient-added dispersion after manual removal. Although further study is required to meet the criteria of the dispensing guidelines of the dispensing guidelines, this method was expeditious and resulted in a high Dantrium® capsule content recovery with minimal capsule shell inclusion.