Medication incidents associated with the provision of medication assistance by non-medical care staff in residential care facilities.

The shift towards community-based care in Japan has led to increased medication assistance for older people by non-medical care staff. These staff members help take pre-packaged medications, apply patches, and administer eye drops. This study assessed the risks associated with such assistance by reviewing medication-related incidents across 106 residential care facilities between April 1, 2015, and March 31, 2016. An analysis of incident reports showed that all incidents were minor, with no serious outcomes. The incidents were categorized into four types: dropped drugs, misdelivery/misuse of medicines, forgetting to take medicines, and loss of medicines, with dropped drugs being the most frequent. Most incidents occurred in the morning and primarily involved residents with intermediate nursing care needs. These findings indicate a low risk of serious incidents because of medication assistance from non-medical staff. However, the frequency and nature of the incidents were influenced by the timing of medication administration and the care needs of the residents. These insights highlight the need for customized approaches to medication assistance, considering the residents' care levels and potentially optimizing medication administration times to improve safety in residential care settings.

[Evaluation of Pharmacists' Active Intervention to Reduce Potentially Inappropriate Medications in Special Older Adult Nursing Home].

Currently, elderly care facilities that do not offer long-term care are not required to employ pharmacists, and duties such as the dispensing and distribution of medicines are entrusted to external pharmacies. Pharmacists seldom spend sufficient time at the facilities for elderly people requiring special care. Thus, in many cases, the pharmacists have insufficient knowledge of the residents' medication status, leading to their inability in determining whether the residents are receiving a suitable drug therapy. We previously documented various problems in the practices adopted by nursing staff (with negligible intervention by pharmacists) for assisting residents in taking their medications. In the present pilot study, we attempted to eliminate the use of potentially inappropriate medications by stationing a pharmacist at a nursing home for 24 h every week (3 d/week). We proactively collected information from nurses and other nursing staff and observed the residents' actual living conditions and medication use. As a result of this intervention, 56 prescriptions were changed. However, only two of these were changed exclusively based on the prescription information. Most prescriptions were able to change based on the information obtained by the pharmacist present at the facility. Therefore, pharmacists' presence at the facility (at least for a few hours) is necessary, as they can actively intervene and collaborate with other staff to prevent the use of potentially inappropriate medications.

The impact of a medical drama featuring a hospital pharmacist on the perception of pharmacists among high school students and guardians: A quasi-experimental study.

Background: A pharmacist's work has shifted from non-personal to in-person services; especially in a super-aging society, further collaboration with other professions is needed. Communication has become an essential skill for pharmacists. However, there is limited public awareness about the work of pharmacists, and their perception among high school students is unclear. Medical dramas have been reported as educational tools for students, including their role in influencing the career choices of health professionals. Objective: This study aimed to evaluate the impact of a TV drama featuring a hospital pharmacist on perceptions of pharmacists among high school students and guardians. Methods: An online survey involving 300 high school students and 300 guardians with their own high school children was conducted before the drama aired, and a post-survey conducted after it finished airing. Regular viewing was defined as exposure in this study. A difference-in-differences approach was used to compare the change in perceptions toward pharmacists' work, required knowledge, aptitude, and communication needs. Results: Comparing before and after they viewed the drama, high school students had significant differences in their perceptions of pharmacist duties such as "one-dose package dispensing" and "health consultation other than medicine," while guardians had different perceptions of "collaboration with health care professionals" and "information sharing about medication therapy." Regarding pharmacist aptitude, only guardians showed significant differences in their perceptions of skills such as "precision," "cooperativeness," and "decisiveness." There were no significant differences in the perceived level of communication required for pharmacists. Conclusions: The results indicated that the portrayal of the pharmacist in the drama may have had some impact on high school students and guardians and was considered useful as an opportunity to learn about pharmacists. However, it was suggested that pharmacists should make the public understand that their work requires real-world communication skills.

Analysis of contributory factors to incidents related to medication assistance for residents taking medicines in residential care homes for the elderly: a qualitative interview survey with care home staff.

BACKGROUND: In Japan, staff who are not doctors or nurses can assist the elderly in residential care facilities to take their pre-packaged medicines. Therefore, there is a potential risk of incidents specific to staffs. The aim of this study was to clarify the causes of incidents related to medication assistance by staff in residential care facilities. METHOD: Semi-structured interviews with staff involved in medication incidents in long-term care facilities, focusing on how and why each incident happened, were conducted. The interview covered basic information about the subject and resident, the circumstances under which the incident had occurred, contributing factors, and countermeasures put in place. Verbatim transcripts of the interviews were prepared. Based on thematic analysis, codes and themes were created. RESULTS: Twelve subjects participated in this study. All subjects were staffs (not doctors or nurses) in long-term care facilities. All incidents covered in this study were incidents in which the wrong resident was given the medication. The incidents arose because of "not following procedures", such as lack of "self-check of residents' faces/residents' names/residents' medicine envelopes" or "double-check with other staff" or "using a device for medication intake". Contributory factors were grouped into four categories: individual resident factor items such as "decreased ability to understand their medication" or "refusal to take medicines", individual staff factor items such as "lack of knowledge related to medication" or "mental burden" or "experience in medication assistance", team factor items such as "failure to communicate with other staff", work environment factor items such as "presence of other residents" or "other work besides medication assistance" or "not enough time" or "little understanding of fostering a safety culture at the facility". CONCLUSION: This study identified four categories of contributory factors that may lead to incidents during medication assistance by caregivers for residents of care homes. These findings should be helpful for risk management in residential care facilities where staff usually provide medication assistance. Separation of meal times and medication assistance, and professional review to stagger the timing of administration of residents' medication may be effective in reducing incidents.

Information provision and retrieval by registered salespersons from consumers during over-the-counter drug sales - a questionnaire survey.

BACKGROUND: In Japan, non-pharmacists who are accredited as registered salespersons can sell over-the-counter (OTC) drugs, and they play a very important role in supporting proper OTC drug use by consumers. The purpose of this study was to evaluate information provided to and information collected from consumers, and cooperation with pharmacists during OTC drug sales by registered salespersons, and to clarify their related concerns and behaviors. METHODS: A cross-sectional questionnaire-based survey of 385 registered salespersons working at 56 drugstores throughout Japan was conducted. Based on the questionnaire survey, the frequency of information provision/collection in various categories was determined for the registered salespersons. The relation between concerns of registered salespersons relating to OTC drug sales and the frequency of information provision/collection was examined. The frequency of consultation of registered salespersons with a pharmacist was calculated for registered salespersons with/without in-store pharmacists. The χ-square test or Fisher's exact test was performed to assess the significance of differences. RESULTS: Two hundred and seven registered salespersons (53.7%) responded completely. A greater number of OTC drug purchasers per day was associated with a greater frequency of information provision about "side effects" and information collection about "favorite items" (alcohol, tobacco, health foods, etc.) (p < 0.05). One hundred and thirty-nine (67.2%) participants had concerns about "interactions between OTC drugs and prescription drugs", and these concerns were related to the frequency of information provision/collection (p < 0.05). Regarding the frequency of consultation with a pharmacist, 35 of 46 participants (76.1%) working with pharmacists answered "always" or "usually", whereas only 19 of 161 participants (11.8%) working without full-time pharmacists answered "always" or "usually". More than half of the registered salespersons thought that cooperation with a pharmacist was necessary when they were "asked about concomitant use with prescription drugs" or "told that side effects happened." CONCLUSIONS: The results of this study show that experienced registered salespersons selling OTC drugs are more likely to collect information from consumers and to provide information to consumers. It appears to be important for registered salespersons to cooperate with pharmacists in order to provide and collect appropriate information about concomitant medications.

Questionnaire survey investigation of the present status of dietetic consultation at community pharmacies from the perspectives of registered dietitians and pharmacists.

BACKGROUND: Registered dietitians are rarely employed at community pharmacies in Japan, even though dietetic advice might benefit some patients. OBJECTIVE: To clarify the present status of dietetic consultation provided by registered dietitians and their collaboration with pharmacists in community pharmacies. METHODS: We conducted a cross-sectional questionnaire-based survey of pharmacists and registered dietitians who work in community pharmacies. The surveyed items were: frequency of dietetic consultation, awareness of one's knowledge and ability to conduct dietetic consultation, concerns, pharmacists' recognition of the need for nutritional support at community pharmacies, and cooperation between registered dietitians and pharmacists. RESULTS: Sixty-six registered dietitians, 53 pharmacists in pharmacies with registered dietitians/dietitians, and 110 pharmacists in pharmacies without registered dietitians/dietitians responded. The frequency of dietetic consultation regarding obesity and hypertension was significantly higher for registered dietitians than for pharmacists. The ability to conduct dietetic consultation regarding diseases/conditions such as kidney disease not requiring dialysis, hyperuricemia, gout, obesity and hypertension was also significantly higher for dietitians than pharmacists. More than 70% of pharmacists recognized the importance of nutritional support at community pharmacies, while 56.1% of registered dietitians noted that they were not able to fully utilize their occupational abilities. Registered dietitians were divided into two groups: registered dietitians who answered that they were able to utilize their occupational abilities and those that answered they were not. The former group was more likely to ask pharmacists about patients' medication for dietetic consultation and to be asked to provide dietetic consultation to patients. The latter group was more likely to find difficulty in scheduling dietetic consultation. CONCLUSION: Our results suggest that registered dietitians in community pharmacies have a greater explanatory ability than pharmacists concerning nutritional and dietary management for patients. It may be important for pharmacists to improve cooperation with registered dietitians by providing more opportunities for dietetic consultation.

[Mothers' Attitudes regarding Medication Administration at Nursery School: A Survey among Mothers with Prior Request Experience to Evaluate Factors Related to the Frequency of Requests to Administer Medication].

The difficulty and anxiety of nursery staff in administering medication to children at nursery schools has been reported, and its reduction is desired. However, the attitudes of mothers in requesting medication and the factors related to a high frequency of requests are not clear. We conducted an online survey of 600 mothers from April to May 2019 regarding the administration of medication at nursery school, and 301 mothers who had previously made such requests were analyzed. The results showed that 100.0% and 76.4% of the mothers felt gratitude and were apologetic for requesting medicine administration, respectively. In total, 47.5% of mothers expected pharmacists to support nursery staff in administering medication. Mothers' attitude of "I think the nursery staff should administer medication to my child more often" was significantly positively associated with a high frequency of the request in adjusted Model [adjusted odds ratio (AOR) 2.75, 95% confidence interval (CI) 1.36-5.55, p=0.005], while "I think the parents should manage so that the children do not have to take medicine in the nursery school so often" showed a negative association (AOR 0.33, 95% CI 0.17-0.66, p=0.002). Factors related to the involvement of community pharmacists were not significant. It is suggested that a change in mothers' attitudes could decrease the frequency of requests and consequently reduce the burden on nursery staff. Community pharmacists may support nursery staff to contribute to changing mothers' attitudes through medication consultations at the pharmacy.

Experimental Study on Patient Preferences Regarding the Shape and Size of Medical Tablets and Capsules Using Three-Dimensionally Printed Plastic Model Formulations.

BACKGROUND: Tablets and capsules are the most common dosage forms. However, ease of use and/or swallowing influences patients' compliance. OBJECTIVE: To identify patients' preferences regarding the three-dimensional size of medical tablets/capsules. METHODS: Eighteen cylindrical-, oblong-, and oval-shaped model formulations having different sizes were prepared by three-dimensional printing using polylactic acid. Participants (40 patients visiting a pharmacy in Japan) evaluated the difficulty of picking up and swallowing these model formulations by touching/observing them, and completed a questionnaire. The visual analogue scale (VAS) was used to evaluate each sample, and the relationship of VAS scores to the major axis, thickness, I2 (the sum of major/minor axes) and I3 (the sum of major/minor axes and thickness) of the model formulations was evaluated by ANOVA followed by Tukey's test. RESULTS: Female participants showed lower VAS scores (less difficult) for picking difficulty compared with male participants, and those taking many drugs showed higher VAS scores (more difficult) for swallowing difficulty compared with those taking fewer drugs. Otherwise, age, gender, disease status, number of drugs usually taken, and ingestion problems did not greatly influence the evaluation. Overall, larger model formulations showed less picking difficulty, but greater swallowing difficulty. Model formulations 2 mm thick or less were harder to pick up, whereas those 6 mm thick or more were harder to swallow. I3 values greater than 20-22 mm were associated with a negative evaluation by participants. CONCLUSION: Participants in this study preferred model formulations with an I3 value below 22 mm and a thickness of 2-6 mm.

[The Situation Concerning Medication Administration at Nursery Schools from the Mothers' Perspective Evaluated Using a Questionnaire].

Previous studies have reported the inappropriate administration of medication at nursery schools by the staff and a lack of drug-related information from caregivers at the time of request. However, the situation concerning medication administration at nursery schools from the mothers' perspective is unknown and it is not clear what information the mothers provided to nursery staff at the request. We conducted an online survey between April and May 2019 regarding the administration of medication at the nursery school with input from 600 mothers. Overall, 510 (85%) individuals replied that the requests to administer medication were acceptable for all or some of the medications. Application forms for medications were used by 91% of the 301 mothers who had previously made such requests. Although information including the child's name, medication times, illness of the child, parent's name, and dosage form was specified by over 70% of mothers, drug-related information such as effectiveness, side effects, and drug interactions was insufficient. In total, 41 instances of inappropriate medication administration by staff were reported by 35 mothers. It is suggested that the drug information sheets provided by community pharmacies should make up for inadequate drug-related information on application forms for medications to avoid the risk of adverse events and reduce staff burden. Toward this end, it is necessary to provide easily understandable information sheets for nursery staff, as the medication is usually administered by nursery staff, not a nurse. Community pharmacists should support these measures as pharmaceutical professionals.

Threshold Size of Medical Tablets and Capsules: Based on Information Collected by Japanese Medical Wholesaler.

BACKGROUND: Medical tablets and capsules are superior with regard to portability and are the most common dosage form in Japan. However, their large size often results in difficulties during ingestion, sometimes leading to reduced medication adherence. OBJECTIVE: The authors used postmarketing surveillance data to determine the threshold size of medical tablets and capsules that patients feel are too large to ingest. PATIENTS AND METHODS: The marketing specialists of Toho Pharmaceutical Co., Ltd. collected opinions of patients and medical workers (November 2014-April 2016). Regarding 709 reports from patients stating that the tablet or capsule for too large for ingestion, a dataset was prepared from package inserts of the reported drugs. Two analyses were conducted: histogram analysis of size distribution and geometric analysis using linear approximation. Six indices of tablet/capsule size were considered: length; length + width; length + width + depth; length × width; length × width × depth; and weight. RESULTS: Histogram analysis revealed that length + width + depth is an excellent index of tablet/capsule size, and negative reports on tablet/capsule size drastically increase when this index is ≥21 mm. Geometric analysis using linear approximation also revealed similar results. CONCLUSION: The threshold size of tablets/capsules that patients feel are too large to ingest is length + width + depth = 21 mm. Therefore, when designing or altering tablets/capsules, if length + width + depth is ≥21 mm, the drug should be scored, split into smaller doses, or redesigned as an orally disintegrating formulation.

Characteristics of "Hard-to-Use" Press-Through-Package Sheets: An Analysis of Information Collected by Marketing Specialists of a Japanese Medical Wholesaler.

BACKGROUND: Press-through-package (PTP) sheets are common forms of packaging for medicines in Japan. However, patients and/or pharmacists have reported difficulty in extracting tablets or capsules from some PTP sheets. OBJECTIVE: We used postmarketing surveillance data to identify the characteristics of PTP sheets that patients and pharmacists feel are "hard to use". METHODS: Marketing specialists of Toho Pharmaceutical Co., Ltd. canvassed patients and medical workers during November 2014-April 2016. Among 1,129 anonymous reports of products being "hard to use", we identified 39 products with 5 or more reports (Problem group). We compared the sizes of the drugs and PTP pockets, the size ratio, the material used for the front of PTPs, the shape of the pockets, the thickness of the pocket wall, and the force needed to release the drug from the PTP (press-out force: POF) in this Problem group with those in a Control group of 97 problem-free products. RESULTS: Logistic regression analyses revealed that a bigger pocket, a smaller drug size and a smaller drug-pocket size ratio increase the risk of being "hard to use". Regarding the material, aluminum, PCTFE and PE increase the risk, while PP and PVC decrease the risk. Other factors had no significant influence. CONCLUSION: Pockets in PTP sheets should be designed so as to minimize the gap between the drug and the pocket, and PP or PVC should be used as the front material instead of aluminum, PCTFE or PE. Our results suggest that marketing specialists can play effective roles in postmarketing surveillance.

[Survey on the Attitudes and Concerns of Nursing Home Staff Regarding Assistance of Medication Administrations in Japan: A Questionnaire Survey].

Care workers at care facilities play an important role in providing medication-administration assistance, and in medication risk management. Nevertheless, research has not made clear the specific concerns that care workers have at work sites, as well as the extent of their burdens. Thus, we conducted a questionnaire survey from October 1 through October 31, 2014 for staff who provide medication-administration assistance at for-pay elderly person homes about the concrete concerns and burdens with regards to the assistance. A total of 1677 respondents were analyzed: 228 nurses and 1449 care workers. Results showed that the care workers had a variety of problems and issues. These included the fact that, since care workers are not medical profession, they were unable to answer questions that the facility residents asked about their medications; they had concerns regarding their own lack of awareness of the efficacies of medications, and as to whether certain drugs were inappropriate for certain patients with swallowing dysfunctions; they wondered whether drugs in tablet forms had to be crushed before administration. They also encountered pharmacological-related issues, including whether administration times and numbers failed to match the lifestyle patterns of facility residents, and so forth. It is presumed that, with active intervention of pharmacists within facilities, these issues could be resolved. Study results, thus, suggested the need for system creation whereby pharmacists can become deeply involved in medication-administration assistance along with the care workers within facilities.

Medications and fall risk: a case-control study in nursing home residents in Japan.

AIM: Falls are a significant problem for older people, but are few studies of the risk of falling in residents of nursing homes in Japan. We aimed to investigate the risk factors for falls and the association of medication use and falls in nursing home residents in Japan. METHODS: This case-control study reviewed the records of residents of who were ≥ 65 years of age and had fallen in 2012 and an age-, sex-, and facility-matched control group selected from 58 nursing homes in Japan. The odds ratios of potential risk factors and current medications were determined by conditional logistic regression. RESULTS: A total of 1832 residents (916 cases and 916 controls) were included. Falls were significantly associated with an inability to walk without assistance or stand up without assistance, need for toileting assistance, visual impairment, insomnia, and dementia. Current prescription of antithrombotic, nonsteroidal anti-inflammatory, or antiparkinson drugs, muscle relaxants, antiepileptics, antipsychotics, antidepressants, opioids, selective serotonin reuptake inhibitors, and memantine was also associated with increased risk of falling. CONCLUSIONS: Many medications were associated with falls in nursing homes residents in Japan. To prevent these falls, caregivers should provide adequate care, and healthcare professionals should consider switching or dose reduction for these medications.

Utility of an adverse drug event database based on the narrative accounts of patients with breast cancer.

Patient narratives of adverse drug events (ADEs) often differ from the symptoms listed on the package inserts of pharmaceutical products using common ADE terminology and could be a source of great comfort to patients with the same disease. To explore this idea, we analyzed written narratives obtained from 48 patients with breast cancer using the NPO Corporation Database of Individual Patients' Experiences, Japan (DIPEx-Japan). Our analysis aimed to determine the utility of an "Adverse Drug Event Database" for use in clinical settings as a novel source of disease information in patients' own words. An analysis of transcripts from 29 patients, in which they recounted their treatment drugs and the time of onset and duration of ADEs in great detail, revealed several discrepancies between the language they used to describe various side effects and the standard ADE terminology on package inserts. We conclude that the language used to describe ADEs on package inserts is insufficient for helping patients as they struggle to recognize, internalize, and overcome ADEs, and argue the need for available, detailed information in the words of real patients about the nature of the ADEs predicted, as well as their clinical course and duration. Such information would be invaluable in supplementing the standardized language used on package inserts. Databases of patients' narrative accounts of ADEs are needed as information sources that can be reliably disseminated among patients.

The process of surplus medicine accumulation by elderly Japanese patients with chronic disease: A qualitative study.

The Japanese government actively urges pharmacists to support efforts to reduce surplus medicines. However, these activities currently serve only to dispose of surplus medicines; no measures are being taken to fundamentally prevent the accumulation of surplus medicines from the outset. A deep understanding of patients' views about storing medicines at home and how they might be accumulating surplus medicines would contribute to the prevention of surplus accumulation. This study aimed to characterize the process by which elderly chronic disease patients in Japan accumulate surplus medicines. Semi-structured interviews were conducted with 18 elderly patients, and the interview data were analyzed using a modified grounded theory approach (M-GTA) to present the process by which surplus medicines were accumulated at patients' homes. The results suggest that elderly patients with chronic diseases often wish to avoid unnecessary medications because of anxiety about medicines, and that these patients seek to maximize medicine suppression. In this context, patients use their own judgment to decide whether to use medicines as needed. Additionally, when patients accumulate surplus medicines, they hesitate to throw them away because they feel that to do so is mottainai (wasteful), or because they accumulate surplus medicines as emergency household medicines. These findings reveal when and how surplus medicine accumulation occurs and the points at which pharmacists can easily intervene to promote a close relationship with patients.

[Questionnaire Survey for Pharmacists to Identify Factors Associated with Confusion Errors Involving Similar-appearing Press-through Package (Blister Pack)].

　Similar-appearing press-through package (PTP) sheets (also known as blister packs) that contain different medicines may result in incorrect medication due to confusion errors. To evaluate the significance of this problem and to identify the factors that may lead to such errors, we conducted a questionnaire survey for pharmacists. Three hundred and eighty-two pairs of PTP sheets with similar appearance were included in the questionnaire. Factors related to color (sheet color at the front of the sheet 90.9%, color of tablet/capsule 57.1%, print color at the front of the sheet 45.9%) were most frequently selected as influencing the perceived similarity of the reported pairs, followed by tablet/capsule shape (46.2%), sheet size (32.4%), and mark and character positioning on sheets (6.8%). In the pairs of similar PTP sheets, pairs manufactured by the same pharmaceutical company accounted for 15%. The frequency of confusion errors or near-errors due to similar appearance of PTP sheets was highest at the time of collecting PTP sheets from the medicine shelf and returning the sheets to the medicine shelf, followed by the time of inspection of prepared medicines and medication instructions. The questionnaire results also indicate that patients themselves can confuse similar PTP sheets and take the wrong medicine. Further quantitative studies are needed to clarify the key factors that cause confusion errors due to similar appearance and to identify potential remedial measures.

Differences in how bronchial asthma patients transmit experience about adverse reactions and usability of inhaled steroids to others: A qualitative focus-group study.

Patients' experience of adverse reactions (ADR) and usability of drugs is important for proper use and post-marketing development of drugs, but it remains unclear whether and how patients are transmitting such information to others. The aim of this study was to explore differences in the ways in which bronchial asthma (BA) patients transmit experience of ADR to inhaled corticosteroids and usability of inhalers to others, including the reasons for these differences. A qualitative study involving focus-group interviews was conducted. Participants were fifteen Japanese BA patients treated with inhaled steroids who belonged to an association for BA patients. Data were analyzed using the constant comparative method. Almost all participants reported behavioral differences concerning ADR and usability. Participants actively expressed their doubts and anxieties about ADR to members of a patients' association and their attending physician. In contrast, information about patients' needs, including opinions and questions about the usability of steroids inhalers and anxieties regarding potential ADR to prolonged use of inhaled steroids, was shared only with members within the association and not disseminated outside, with some participants even choosing to keep it personal. Underlying this behavior was a mindset of perceiving efficacy and ADR to be more important than usability, and thinking "it is useless to inform anyone." In conclusion, behavioral differences of how BA patients transmit experience about ADR and usability was obvious, because benefit to inform usability was not perceived. It is necessary to make patients aware that transmitting their experience and comments about drugs is beneficial.

Quantitative prediction of fetal plasma concentration of fluvoxamine during dosage-tapering to the mother.

INTRODUCTION: Although selective serotonin reuptake inhibitors have been used during pregnancy for the treatment of depression and anxiety disorders, the fetal plasma concentration profiles of them remained unclear. Therefore, the aim of this study was to develop a pharmacokinetic model to estimate fetal plasma concentration profiles of fluvoxamine, and to clarify the differences with those of paroxetine. METHODS: Perfusion studies using human placentae obtained from full-term pregnant women were conducted to estimate transplacental pharmacokinetic parameters for fluvoxamine. The characteristics of placental permeability were compared with those of paroxetine in our previous report. Using a developed model and these parameters, fetal plasma concentration profiles of fluvoxamine administered to mothers were simulated. RESULTS: The results of perfusion studies and transplacental transfer kinetic parameters indicated that fluvoxamine is less efficiently distributed to placental tissue than paroxetine. The model predicted a maternal-fetal plasma concentration ratio of 0.376 after repeated maternal administration of fluvoxamine, similar to the ratio for paroxetine. However, if the mother ceased taking drug, the model predicted a half-life of fluvoxamine in fetal plasma of 35 h, which is longer than that of paroxetine (10 h). We used the model to evaluate a proposed taper regimen for full-term pregnant women taking fluvoxamine that would minimize the risk of neonatal withdrawal syndrome. DISCUSSION: The obtained parameters and developed model enabled us to predict the fetal plasma concentration profiles of fluvoxamine. The risk of neonatal withdrawal syndrome due to abrupt discontinuation may be less with fluvoxamine than with paroxetine.

What the Desirable Collaboration between Care Workers in Nursing Homes and Phamacists Should Be: An Approach for Security and Safe Medication for Residents in Nursing Homes.

In our previous research, there was no collaboration between care workers and pharmacists, for the most part. As a result, it was discovered that in some cases, problems concerning medication of nursing home residents had not been resolved. To solve this issue, we brought together care workers and pharmacists for a workshop we conducted. We assigned 12 care workers with at least two years of experience and 12 pharmacists to four mixed groups and guided them in the management of in-home long-term medical care and conducted small group discussions (SGD) using the KJ method. In the pre-survey before the workshop, all 12 care workers replied "yes" to having experienced "concerns over medication" and nine (75%) replied "no" to having experienced "discussions (consultations) with pharmacists regarding the medication of residents". As a result of the SGD, "information sharing among professionals" was revealed as a problem common to all groups. Furthermore, common countermeasures for this issue included communication notes and holding collaborative meetings. In the post-survey after the workshop, 67% of the participants replied that their thoughts concerning countermeasures were "coherent", and everyone replied that their "awareness was increased". In a follow-up survey after the workshop, 82% of the participants replied that they were using some form of what they had learned and discovered in the workshop in their actual work.

Analysis of the Mechanism of Prolonged Persistence of Drug Interaction between Terbinafine and Amitriptyline or Nortriptyline.

The purpose of the study was to quantitatively estimate and predict drug interactions between terbinafine and tricyclic antidepressants (TCAs), amitriptyline or nortriptyline, based on in vitro studies. Inhibition of TCA-metabolizing activity by terbinafine was investigated using human liver microsomes. Based on the unbound Ki values obtained in vitro and reported pharmacokinetic parameters, a pharmacokinetic model of drug interaction was fitted to the reported plasma concentration profiles of TCAs administered concomitantly with terbinafine to obtain the drug-drug interaction parameters. Then, the model was used to predict nortriptyline plasma concentration with concomitant administration of terbinafine and changes of area under the curve (AUC) of nortriptyline after cessation of terbinafine. The CYP2D6 inhibitory potency of terbinafine was unaffected by preincubation, so the inhibition seems to be reversible. Terbinafine competitively inhibited amitriptyline or nortriptyline E-10-hydroxylation, with unbound Ki values of 13.7 and 12.4 nM, respectively. Observed plasma concentrations of TCAs administered concomitantly with terbinafine were successfully simulated with the drug interaction model using the in vitro parameters. Model-predicted nortriptyline plasma concentration after concomitant nortriptylene/terbinafine administration for two weeks exceeded the toxic level, and drug interaction was predicted to be prolonged; the AUC of nortriptyline was predicted to be increased by 2.5- or 2.0- and 1.5-fold at 0, 3 and 6 months after cessation of terbinafine, respectively. The developed model enables us to quantitatively predict the prolonged drug interaction between terbinafine and TCAs. The model should be helpful for clinical management of terbinafine-CYP2D6 substrate drug interactions, which are difficult to predict due to their time-dependency.