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Background: Substantial numbers of hospital readmissions occur due to medication-related problems. Pharmacists can implement different interventions at hospital discharge that aim to reduce those readmissions. It is unclear which pharmacist-led interventions at hospital discharge are the most promising in reducing readmissions., Aim: This scoping review aimed to summarise pharmacist-led interventions conducted at hospital discharge that demonstrated a reduction in readmissions., Method: We searched the MEDLINE, EMBASE and CINAHL databases up to February 2024. We included studies that focused on pharmacist-led interventions at hospital discharge and reported significant readmission reductions. Two reviewers independently screened titles, abstracts and full texts. Data extracted included study characteristics, populations and the type of implemented pharmacist-led interventions along with the reduction in readmission rates achieved., Results: We included 25 articles for data synthesis. Many of the studies included either implemented at least two interventions concurrently or were part of broader programmes involving other healthcare professionals. The most common pharmacist-led interventions associated with reduced readmission rates included medication reconciliation, counselling and post-discharge follow-up by telephone. Follow-up primarily aimed to improve patients' treatment adherence through education about their medications. Furthermore, many studies reported on multi-component interventions that began at hospital admission or during inpatient stays, not only at discharge., Conclusion: Successfully reducing readmissions through pharmacist-led interventions at hospital discharge suggests the effectiveness of a holistic approach incorporating multiple interventions. While these findings offer insights for pharmacists, further research should focus on conducting high-quality studies using a multifaceted approach to identify the most appropriate timing and combination., Competing Interests: Conflicts of interest: The authors have no relevant financial or non-financial interests to declare., (© 2024. The Author(s).)

Background: The present study sought to determine the prevalence of chronic non-cancer pain (CNCP) among older adult inpatients with polypharmacy. It also aimed to analyse prescription patterns and assess the therapy adequacy and patient complexity for those with and without CNCP., Methods: This 4-year longitudinal study examined data from an exhaustive acute care hospital register on home-dwelling older adult patients (≥65) with polypharmacy. Commonly known combinations of potentially inappropriate medications were used to estimate therapy adequacy. Patient complexity was evaluated by comparing number of comorbidities and investigating physical and cognitive deficits., Results: We determined a prevalence of CNCP of 9.7% among all older adult inpatients with polypharmacy, rising to 11.3% for those aged ≥85. Overall, CNCP patients were prescribed more drugs and had more comorbidities and physical and cognitive deficits than patients without CNCP. Older adult patients with CNCP received more analgesics, greater quantities of opioids, paracetamol and co-analgesics and elevated opioid dosages. Older adult patients with CNCP aged ≥85 received fewer analgesics, opioids, non-steroidal anti-inflammatory drugs and co-analgesics but more paracetamol. Older adult patients with CNCP were prescribed more potentially inappropriate medications involving opioids. In particular, 24.5% received an opioid and a hypnotic (benzodiazepine or Z-drug), and 8.6% received an opioid and a gabapentinoid., Conclusion: Observed differences in medication use between older adult inpatients with or without CNCP may be relevant for clinical practice. Potentially inadequate co-prescribing (such as hypnotics and opioids) affects a higher proportion of patients with CNCP and may have serious unintended consequences., Significance Statement: This study describes differences in prescription patterns between people with and without chronic non-cancer pain in a large dataset of 20,422 discharges. The differences found may be relevant to clinical practice. In particular, high co-prescribing of opioids and hypnotics may have serious unintended consequences. Greater physical and cognitive deficits may indicate greater patient complexity, and appropriate interventions need to be developed to improve the management of this vulnerable patient group., (© 2024 The Author(s). European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation ‐ EFIC ®.)

Background: Chronic non-cancer pain may affect up to 51% of the general population. Pharmacist interventions have shown promise in enhancing patient safety and outcomes. However, our understanding of the scope of pharmacists' interventions remains incomplete., Aim: Our goal was to characterise pharmacists' interventions for the management of chronic non-cancer pain., Method: Medline, Embase, PsycINFO via Ovid, CINAHL via EBSCO databases and the Cochrane Library were systematically searched. Abstracts and full texts were independently screened by two reviewers. Data were extracted by one reviewer, and validated by the second. Outcomes of studies were charted using the dimensions of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)., Results: Forty-eight reports were included. Interventions ensuring appropriate drug prescription occurred in 37 (79%) studies. Patient education and healthcare professional education were reported in 28 (60%) and 5 (11%) studies, respectively. Therapy monitoring occurred in 17 (36%) studies. Interventions regularly involved interprofessional collaboration. A median of 75% of reported outcome domains improved due to pharmacist interventions, especially patient disposition (adherence), medication safety and satisfaction with therapy., Conclusion: Pharmacists' interventions enhanced the management of chronic non-cancer pain. Underreported outcome domains and interventions, such as medication management, merit further investigation., (© 2024. The Author(s).)

Excessive daytime sleepiness (EDS) and insomnia (IN) complaints represent the most common sleep/wake disorders. Currently, the specific needs of these patients and their relatives, as well as the overall socio-economic burden of IN and EDS remains widely unexplored. This pilot study to be carried out in Switzerland is a retro- and prospective, national, one-center cohort observational study for the systematic evaluation of the burden of EDS and IN and its evolution 12 months after the first assessment. Patient recruitment will be organized through 7-8 primary care providers (primary/general care practitioners and pharmacies). Primary outcomes are the prevalence of EDS/IN in the primary care setting and the association between EDS/IN with health-related quality of life (QOL) as assessed with the established instruments. Secondary outcomes are the association between EDS/IN with the presence of comorbidities, number of injuries/accidents, and number of sick/leave days for the subgroup of working subjects. Calculation of direct per-patient costs will be undertaken to analyze the economic implications of sleep/wake disorders, providing valuable insights into the financial burden experienced by affected individuals within the healthcare system. This research will provide information on the feasibility of such a study and inform on aspects of the QOL most associated with EDS/IN. Based on this pilot project, a European multicenter study on the burden of sleep/wake disorders will be conducted by the European Academy of Neurology.

Background: Medication-related readmissions challenge healthcare systems by burdening patients, increasing costs and straining resources. However, to date, there has been no consensus study on indicators for medication-related readmissions., Objectives: This Delphi study aimed to develop a consensus-based set of indicators for detecting patients at risk of medication-related readmission., Methods: An expert panel of clinical pharmacists, physicians and nursing experts participated in a two-round Delphi study. In round 1, 31 indicators taken from the literature were rated for relevance on a scale from 1 to 9, with a median rating of 7 or higher suggesting relevance. The RAND/UCLA method was used to determine consensus. In round 2, indicators lacking consensus were re-rated together with a series of new indicators generated by the experts. Additional details were sought for some indicators. The main outcomes were the relevance of, consensus on, and completeness of the proposed indicators for identifying risks of 30-day medication-related readmission., Results: Thirty-eight experts participated in round 1. Consensus was found for all the indicators, with 25 included and 6 excluded. Thirty-four experts participated in round 2. Consensus was found for all 5 newly suggested indicators, and 4 were included. The expert panel prioritized the following indicators: (1) insufficient communication between different healthcare providers, (2) polypharmacy (≥7 medications), (3) low rates of medication adherence (twice-weekly mistakes or missing administration), (4) complex medication regimens (≥3 doses, ≥2 dosage forms and ≥2 administration routes per day), and (5) multimorbidity (≥3 chronic conditions). The final set comprised 29 indicators., Conclusions: The indicator set developed for flagging potential medication-related readmissions could guide priorities for clinical pharmacy services at hospital discharge, improving patient outcomes and resource use. A validation study of these indicators is planned., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Homecare client services are often distributed across several interdependent healthcare providers, making proper care coordination essential. However, as studies exploring care coordination in the homecare setting are scarce, serious knowledge gaps exist regarding how various factors influence coordination in this care sector. To fill such gaps, this study's central aim was to explore how external factors (i.e., financial and regulatory mechanisms) and homecare agency characteristics (i.e., work environment, workforce, and client characteristics) are related to care coordination in homecare., Methods: This analysis was part of a national multicentre, cross-sectional study in the Swiss homecare setting that included a stratified random sample of 88 Swiss homecare agencies. Data were collected between January and September 2021 through agency and employee questionnaires. Using our newly developed care coordination framework, COORA, we modelled our variables to assess the relevant components of care coordination on the structural, process, and outcome levels. We conducted both descriptive and multilevel regression analyses-with the latter adjusting for dependencies within agencies-to explore which key factors are associated with coordination., Results: The final sample size consisted of 1450 employees of 71 homecare agencies. We found that one explicit coordination mechanism ("communication and information exchange" (beta = 0.10, p <.001)) and four implicit coordination mechanisms-"knowledge of the health system" (beta = -0.07, p <.01), "role clarity" (beta = 0.07, p <.001), "mutual respect and trust" (beta = 0.07, p <.001), and "accountability, predictability, common perspective" (beta = 0.19, p <.001)-were significantly positively associated with employee-perceived coordination. We also found that the effects of agency characteristics and external factors were mediated through coordination processes., Conclusion: Implicit coordination mechanisms, which enable and enhance team communication, require closer examination. While developing strategies to strengthen implicit mechanisms, the involvement of the entire care team is vital to create structures (i.e., explicit mechanisms) that enable communication and information exchange. Appropriate coordination processes seem to mitigate the association between staffing and coordination. This suggests that they support coordination even when workload and overtime are higher., (© 2024. The Author(s).)

Background and Objective: The term triple whammy (TW) refers to the concomitant use of non-steroidal anti-inflammatory drugs, diuretics, and angiotensin system inhibitors; this combination significantly increases the risk of acute kidney injury (AKI). To prevent this serious complication, we developed an electronic algorithm that detects TW prescriptions in patients with additional risk factors such as old age and impaired kidney function. The algorithm alerts a clinical pharmacist who then evaluates and forwards the alert to the prescribing physician., Methods: We evaluated the performance of this algorithm in a retrospective observational study of clinical data from all adult patients admitted to the Cantonal Hospital of Aarau in Switzerland in 2021. We identified all patients who received a TW prescription, had a TW alert, or developed AKI during TW therapy. Algorithm performance was evaluated by calculating the sensitivity and specificity as a primary endpoint and determining the acceptance rate among clinical pharmacists and physicians as a secondary endpoint., Results: Among 21,332 hospitalized patients, 290 patients had a TW prescription, of which 12 patients experienced AKI. Overall, 216 patients were detected by the alert algorithm, including 11 of 12 patients with AKI; the algorithm sensitivity is 88.3% with a specificity of 99.7%. Physician acceptance was high (77.7%), but clinical pharmacists were reluctant to forward the alerts to prescribers in some cases., Conclusion: The TW algorithm is highly sensitive and specific in identifying patients with TW therapy at risk for AKI. The algorithm may help to prevent AKI in TW patients in the future., (© 2024. The Author(s).)

Pharmacy and therapeutics committees (PTCs) are multidisciplinary hospital teams responsible for rational medication use. We aimed at developing and piloting an assessment tool for their operating quality.We conducted a scoping literature review in PubMed and Embase to identify potential assessment items. Their relevance was systematically rated and consolidated into the final tool.60 relevant items were included, grouped into eight focus topics: the committee's institutional integration, member characteristics, performance indicators, meeting structure, formulary decision-making and characteristics, strategies to guide medication use and medication use evaluations.In combination with a SWOT (strengths, weaknesses, opportunities and threats) analysis, the tool helped the identification of improvement opportunities for a pilot hospital: adapting the committee's structure, improving the formulary decision-making, implementing strategies to guide formulary medication use and strengthening the committee's recognition within the institution.The tool successfully identified improvement opportunities for a PTC and could therefore be interesting for other hospitals., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Background: Medication safety is important to limit adverse events for nursing home residents. Several factors, such as interprofessional collaboration with pharmacists and medication reviews, have been shown in the literature to influence medication safety processes., Aim: This study had three main objectives: (1) To assess how facility- and unit-level organization and infrastructure are related to medication use processes; (2) To determine the extent of medication safety-relevant processes; and (3) To explore pharmacies' and pharmacists' involvement in nursing homes' medication-related processes., Method: Cross-sectional multicenter survey data (2018-2019) from a convenience sample of 118 Swiss nursing homes were used. Data were collected on facility and unit characteristics, pharmacy services, as well as medication safety-related structures and processes. Descriptive statistics were used., Results: Most of the participating nursing homes (93.2%) had electronic resident health record systems that supported medication safety in various ways (e.g., medication lists, interaction checks). Electronic data exchanges with outside partners such as pharmacies or physicians were available for fewer than half (10.2-46.3%, depending on the partner). Pharmacists collaborating with nursing homes were mainly involved in logistical support. Medication reviews were reportedly conducted regularly in two-thirds of facilities., Conclusion: A high proportion of Swiss nursing homes have implemented diverse processes and structures that support medication use and safety for residents; however, their collaboration with pharmacists remains relatively limited., (© 2023. The Author(s).)

Objective: This study aimed to investigate medication management among polymedicated, home-dwelling older adults after discharge from a hospital centre in French-speaking Switzerland and then develop a model to optimise medication management and prevent adverse health outcomes associated with medication-related problems (MRPs)., Design: Explanatory, sequential, mixed methods study based on detailed quantitative and qualitative findings reported previously., Setting: Hospital and community healthcare in the French-speaking part of Switzerland., Participants: The quantitative strand retrospectively examined 3 years of hospital electronic patient records (n=53 690 hospitalisations of inpatients aged 65 years or older) to identify the different profiles of those at risk of 30-day hospital readmission and unplanned nursing home admission. The qualitative strand explored the perspectives of older adults (n=28), their informal caregivers (n=17) and healthcare professionals (n=13) on medication management after hospital discharge., Results: Quantitative results from older adults' profiles, affected by similar patient-related, medication-related and environment-related factors, were enhanced and supported by qualitative findings. The combined findings enabled us to design an interprofessional, collaborative medication management model to prevent MRPs among home-dwelling older adults after hospital discharge. The model comprised four interactive fields of action: listening to polymedicated home-dwelling older adults and their informal caregivers; involving older adults and their informal caregivers in shared, medication-related decision-making; empowering older adults and their informal caregivers for safe medication self-management; optimising collaborative medication management practices., Conclusion: By linking the retrospective and prospective findings from our explanatory sequential study involving multiple stakeholders' perspectives, we created a deeper comprehension of the complexities and challenges of safe medication management among polymedicated, home-dwelling older adults after their discharge from hospital. We subsequently designed an innovative, collaborative, patient-centred model for optimising medication management and preventing MRPs in this population., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: As health care complexity increases, skilled care coordination is becoming increasingly necessary. This is especially true in homecare settings, where services tend to be highly interprofessional. Poor coordination can result in services being provided twice, at the wrong time, unnecessarily or not at all. In addition to risking harm to the client, such confusion leads to unnecessary costs. From the patient's perspective, then, professional coordination should help both to remove barriers limiting quality of care and to minimize costs. To date, though, studies examining the relationship between care coordination and care quality have faced multiple challenges, leading to mixed results. And in homecare contexts, where the clients are highly vulnerable and diverse care interfaces make coordination especially challenging, such studies are rare., Objectives: Therefore, the aim of this study was to explore the relationship, from the perspectives of clients and of homecare professionals, between coordination and quality of care. For both groups, we hypothesized that better coordination would correlate with higher ratings of quality of care. For the clients, we predicted that higher coordination ratings would lead to lower incidence of unplanned health care use, i.e., emergency department (ED) visits, unscheduled urgent medical visits and hospitalizations., Design and Methods: This study is part of a national multi-center cross-sectional study in the Swiss homecare setting. We recruited 88 homecare agencies and collected data between January and September 2021 through written questionnaires for agencies' managers, employees (n = 3223) and clients (n = 1509). To test our hypotheses, we conducted multilevel analyses., Results: Employee-perceived care coordination ratings correlated positively with employee-rated quality of care (OR = 2.78, p < .001); client-perceived care coordination problems correlated inversely with client-reported quality of care (β = -0.55, p < .001). Client-perceived coordination problems also correlated positively with hospitalizations (IRR = 1.20, p < .05) and unscheduled urgent medical visits (IRR = 1.18, p < .05), but not significantly with ED visits. No associations were discernible between employee-perceived coordination quality and either health care service use or client quality-of-care ratings., Discussion: While results indicate relationships between coordination and diverse aspects of care quality, various coordination gaps (e.g., poor information flow) also became apparent. The measurement of both care coordination and quality of care remains a challenge. Further research should focus on developing and validating a coordination questionnaire that measures care coordination., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: In hospice and palliative care, drug therapy is essential for symptom control. However, drug regimens are complex and prone to drug-related problems. Drug regimens must be simplified to improve quality of life and reduce risks associated with drug-related problems, particularly at end-of-life. To support clinical guidance towards a safe and effective drug therapy in hospice care, it is important to understand prescription trends., Objectives: To explore prescription trends and describe changes to drug regimens in inpatient hospice care., Design: We performed a retrospective longitudinal and descriptive analysis of prescriptions for regular and as-needed (PRN) medication at three timepoints in deceased patients of one Swiss hospice., Setting/subjects: Prescription records of all patients ( ≥ 18 years) with an inpatient stay of three days and longer (admission and time of death in 2020) were considered eligible for inclusion., Results: Prescription records of 58 inpatients (average age 71.7 ± 12.8 [37-95] years) were analyzed. The medication analysis showed that polypharmacy prevalence decreased from 74.1% at admission to 13.8% on the day of death. For regular medication, overall numbers of prescriptions decreased over the patient stay while PRN medication decreased after the first consultation by the attending physician and increased slightly towards death., Conclusions: Prescription records at admission revealed high initial rates of polypharmacy that were reduced steadily until time of death. These findings emphasize the importance of deprescribing at end-of-life and suggest pursuing further research on the contribution of clinical guidance towards optimizing drug therapy and deprescribing in inpatient hospice care.

(1) Introduction: Chronic insomnia (CI) reduces quality of life and may trigger depression and cardiovascular diseases. The European Sleep Research Society recommends cognitive behavioural therapy (CBT-I) as the first-line treatment. Because a recent study in Switzerland demonstrated that this recommendation was inconsistently followed by primary care physicians, we hypothesised that pharmacists also deviate from these guidelines. The aim of this study is to describe current treatment practices for CI recommended by pharmacists in Switzerland, compare them to guidelines and examine their attitudes towards CBT-I. (2) Methods: A structured survey was sent to all the members of the Swiss Pharmacists Association, containing three clinical vignettes describing typical CI pharmacy clients. Treatments had to be prioritised. The prevalence of CI, and the pharmacists' knowledge and interest in CBT-I were assessed. (3) Results: Of 1523 pharmacies, 123 pharmacists (8%) completed the survey. Despite large variations, valerian (96%), relaxation therapy (94%) and other phytotherapies (85%) were most recommended. Although most pharmacists did not know about CBT-I (72%) and only 10% had recommended it, most were very interested (64%) in education. Missing financial compensation hampers the recommendation of CBT-I. (4) Conclusions: Contrary to existing European guidelines, community pharmacists in Switzerland mostly recommended valerian, relaxation therapy and other phytotherapies for treating CI. This might be connected to the client's expectation of pharmacy services, e.g., medication dispensing. While pharmacists recommend sleep hygiene regularly, most did not know of CBT-I as an overarching concept but were willing to learn. Future studies should test the effects of dedicated training about CI and changes in the financial compensation for counselling for CI in pharmacies.

Background: Pharmacists contribute to medication safety by providing their services in various settings. However, standardized definitions of the role of pharmacists in hospice and palliative care (HPC) are lacking., Aim: The purpose of this scoping review was to provide an overview of the evidence on the role of pharmacists and to map clinical activities in inpatient HPC., Method: We performed a scoping review according to the PRISMA-ScR extension in CINAHL, Embase, and PubMed. We used the American Society of Hospital Pharmacists (ASHP) Guidelines on the Pharmacist's Role in Palliative and Hospice Care as a framework for standardized categorization of the identified roles and clinical activities., Results: After screening 635 records (published after January 1st, 2000), the scoping review yielded 23 publications reporting various pharmacy services in HPC. The articles addressed the five main categories in the following descending order: 'Medication order review and reconciliation', 'Medication counseling, education and training', 'Administrative Roles', 'Direct patient care', and 'Education and scholarship'. A total of 172 entries were mapped to the subcategories that were added to the main categories., Conclusion: This scoping review identified a variety of pharmacists' roles and clinical activities. The gathered evidence will help to establish and define the role of pharmacists in inpatient hospice and palliative care., (© 2023. The Author(s).)

Effective healthcare coordination is vital when such care is provided as a collaborative effort by many individuals and their task activities are interdependent. Coordination is necessary to ensure that care not only meets the needs of patients, but also avoids negative consequences for them due to omitted, inefficient, unnecessary, or even incorrect treatments. It also helps conserve resources. This has contributed to a rapid increase in articles on this subject. Still, while care coordination topics are gaining the attention of researchers, there are a number of issues experienced, including the delineation of limitations, inconsistent definitions, and problems with measurement. Therefore, the aim of this article is to refine the concept of homecare coordination and provide a comprehensive theoretical framework, illustrated with examples from practice. Focusing on this goal, we have reviewed the extant literature on the subject to develop a theoretical homecare coordination framework. The first intermediary goal was to integrate relevant concepts across multiple theories and frameworks into a unified synthesis. We do so in two parts: (1) analysis of extant coordination frameworks and theories; and (2) the presentation of our newly developed theoretical framework for homecare coordination. The new framework differentiates clearly between coordination as a process-i.e., what people do to coordinate and coordination as an outcome-i.e., the state of coordination. Applying this distinction to both, measurement and interpretation of results helps avoid misleading conclusions. As a research outcome, our framework builds upon the extant coordination literature, considers the complex relationships among the various coordination-related factors and, while focusing on homecare, is applicable to various healthcare settings in general. A nuanced differentiation and explanation of the elements involved enable a more consistent operationalization of the coordination concept. Additionally, as they explicitly address the healthcare system's micro, meso, and macro levels, they can be applied across diverse healthcare settings to investigate homecare coordination., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

Background: Effective medication management is one of the essential preconditions for enabling polymedicated home-dwelling older adults with multiple chronic conditions to remain at home and preserve their quality of life and autonomy. Lack of effective medication management predisposes older adults to medication-related problems (MRPs) and adverse health outcomes, which can lead to the degradation of a patient's acute clinical condition, physical and cognitive decline, exacerbation of chronic medical conditions, and avoidable health care costs. Nonetheless, it has been shown that MRPs can be prevented or reduced by using well-coordinated, patient-centered, interprofessional primary care interventions., Objective: This study aimed to explore the feasibility and acceptability of an evidence-based, multicomponent, interprofessional intervention program supported by informal caregivers to decrease MRPs among polymedicated home-dwelling older adults with multiple chronic conditions., Methods: This quasi-experimental, pre-post, multisite pilot, and feasibility study will use an open-label design, with participants knowing the study's objectives and relevant information, and it will take place in primary health care settings in Portugal and Switzerland. The research population will comprise 30 polymedicated, home-dwelling adults, aged ≥65 years at risk of MRPs and receiving community-based health care, along with their informal caregivers and health care professionals., Results: Before a projected full-scale study, this pilot and feasibility study will focus on recruiting and ensuring the active collaboration of its participants and on the feasibility of expanding this evidence-based, multicomponent, interprofessional intervention program throughout both study regions. This study will also be essential to projected follow-up research programs on informal caregivers' multiple roles, enhancing their coordination tasks and their own needs. Results are expected at the end of 2024., Conclusions: Designing, establishing, and exploring the feasibility and acceptability of an intervention program to reduce the risks of MRPs among home-dwelling older adults is an underinvestigated issue. Doing so in collaboration with all the different actors involved in that population's medication management and recording the first effects of the intervention will make this pilot and feasibility study's findings very valuable as home care becomes an ever more common solution., Trial Registration: Swiss National Clinical Trials Portal 000004654; https://tinyurl.com/mr3yz8t4., (©Filipa Pereira, Maria dos Anjos Dixe, Sónia Gonçalves Pereira, Carla Meyer-Massetti, Henk Verloo. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 25.01.2023.)

Ageing is frequently associated with multimorbidity and polypharmacy. The present study aimed to identify the current medication management patterns and the profiles of home-dwelling older adults and to find any association with their conditions, including frailty and cognitive impairment. Within the scope of this cross-sectional study, 112 older adults living in the community were assessed via face-to-face structured interviews. Frailty, cognitive status, medication management and clinical and sociodemographic variables were evaluated. Descriptive and inferential statistics were calculated. The mean participant age was 76.6 ± 7.1 years, 53.6% of participants were women, and 40.2% of participants lived alone. More than half were classified as having frailty (58.9%), almost one-fifth (19.6%) presented with a moderate cognitive impairment had more than one disease, and 60.7% were polymedicated. No associations were found between polymedication and medication self-management, the use of over-the-counter medications, living alone, having a poor understanding of pharmacological therapy and/or pathology, or having more than one prescriber. Self-management was associated with age, the number of medications, frailty and cognitive status. Binary logistic regressions showed that cognitive impairment had statistically significant differences with medication management, having a poor understanding of pharmacological therapy and/or pathology, having one prescriber and the use of medications not prescribed by physicians. Interventions to prevent medication-related problems in home-dwelling older adults are recommended.

Aim: To develop a consensus-based instrument [MELIA] to assess the medication literacy of older home care patients to ultimately optimize medication safety., Design: This study was part of the project 'Study of Medication Safety in Home Care' (doMESTIC), which took place from 2016 to 2020 in Switzerland. The development process for the medication literacy assessment instrument encompassed six steps., Method: First, a scoping literature search was conducted in the Pubmed, CINAHL, EMBASE and Cochrane Library databases as 2) a basis for the development of assessment items. This was followed by 3) a cognitive interview with home care patients and 4) the first round of a Delphi process. Then, 5) a focus group interview with home care experts was conducted before 6) the second Delphi round. The project took place between August 2020 and June 2021. With these different steps, perspectives of both patients and various home care and medication safety experts were included in the development of the assessment instrument., Results: A detailed instrument consisting of 20 items as well as a 7-item short version were developed. The short version is intended for efficient preliminary screening to identify patients at high risk for medication management-related problems., Conclusion: Medication literacy in patients 65 years and older receiving professional home care is a key issue in preventing medication errors. A targeted assessment, starting with an efficient short version of MELIA, allows for prioritization of patients for interventions to optimize medication safety while ensuring their independence as much as possible., Impact: Systematic assessment of patients' medication literacy helps to provide them with targeted and individual support in their medication management to avoid medication errors and increase patient safety. The development of MELIA is a first step in providing an assessment instrument specifically for the home care setting., Patient or Public Contribution: Patient participation was an integral part of the instrument development. The initial 23 items were optimized based on cognitive interviews with four home care patients. The next steps of the instrument development were based on feedback of health care professionals-encompassing advance practice nurses, regular nurses, pharmacists and general practitioners-during a two-step Delphi process as well as a focus group discussion., (© 2022 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.)

Background: Professional home care nurses are often tasked with the medication management of older, polymedicated clients. The medication use process is often complex and prone to medication errors. From the perspective of professional caregivers, the interprofessional interfaces of care as well as the integration of clients and informal caregivers are a major challenge., Aim: With this study, we explored the perspective of home care clients and their informal caregivers on the medication use process supported by professional caregivers with a focus on medication safety., Method: We chose a qualitative research approach, using guideline-based interviews with eight clients and five caregivers. Data were analyzed applying the topical analysis according to Braun and Clarke., Results and Discussion: Before engaging professional home care nurses in the medication use process, clients reached their physical, psychological and social limits. They were relieved when the professional home care organization took care of the overall coordination of the medication use process and felt safe. They trust professional caregivers and see limited need to be preoccupied with medication safety themselves, despite risks inherent in self-medication, adherence and transition of care., Conclusion: Through the relief provided by professional caregivers, home care clients and their informal caregivers no longer perceive themselves as active partners in maintaining medication safety. Healthcare professionals should keep an eye on self-medication as well as adherence and support the use of the medication plan., (© 2021. The Author(s).)

Background: Subcutaneous drug administration is an interesting approach for symptom control in hospice and palliative care. However, most drugs have no marketing authorization for subcutaneous administration and are therefore used off-label. In order to meet the requirements of a safe and effective drug therapy, especially in highly vulnerable patients, it is essential to investigate the scope of evidence of these common practices., Objectives: The purpose of this scoping review was to provide an overview of available data on the tolerability and/or effectiveness of subcutaneously administered and off-label used drugs., Method: We performed a scoping review according to the PRISMA extension to identify data available on the tolerability and/or effectiveness of 17 predefined drugs that are commonly administered subcutaneously in Swiss hospices and hospice-like institutions and that have no marketing authorization (off-label use)., Results: The scoping review identified 57 studies with most data available on their tolerability (68% local, 54% systemic), clinical effects (82%), details on dosage (96%) and routes of application (100%). Information on pharmacokinetic properties was mostly missing and only available for fentanyl, levetiracetam, midazolam, and ondansetron. For seven drugs, less than five articles were identified and no studies on codeine or clonazepam were available., Conclusion: This work provides an overview of current evidence on subcutaneous and off-label used drugs in hospice and palliative care. Although both are common practices, evidence on tolerability and effectiveness, particularly pharmacokinetic data, is limited and the identified information gaps need to be closed. This work establishes a basis for further research in this area., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Information on medication utilization among pregnant and postpartum women during the pandemic is lacking. We described the prevalence and patterns of self-reported medication use among pregnant and postpartum women during the third wave of the pandemic (June-August 2021). An online questionnaire was distributed in five European countries between June-August 2021. Pregnant women or women who had delivered in the three preceding months, and ≥18 years old, could participate. The prevalence of overall medication use, self-medication, and changes in chronic medication use were determined. A total of 2158 women out of 5210 participants (41.4%) used at least one medication. Analgesics (paracetamol), systemic antihistamines (cetirizine), and drugs for gastric disorders (omeprazole) were the three most used classes. Anti-infectives were less prevalent than during pre-pandemic times. Antidepressants and anxiety related medication use remained similar, despite a higher prevalence of these symptoms. Self-medication was reported in 19.4% of women, and 4.1% of chronic medication users reported that they changed a chronic medication on personal initiative due to the pandemic. In conclusion, medication use patterns in our cohort were mostly similar to those of the first COVID-19 wave and the pre-pandemic period. More studies are needed to explore factors associated with self-medication and changes in chronic medication use due to the pandemic in this perinatal population.

Objective: To investigate patient characteristics and the available health and drug data associated with unplanned nursing home admission following an acute hospital admission or readmission., Design: A population-based hospital registry study., Setting: A public hospital in southern Switzerland (Valais Hospital)., Participants: We explored a population-based longitudinal dataset of 14 705 hospital admissions from 2015 to 2018., Outcome Measures: Sociodemographic, health and drug data, and their interactions predicting the risk of unplanned nursing home admission., Results: The mean prevalence of unplanned nursing home admission after hospital discharge was 6.1% (n=903/N=14 705). Our predictive analysis revealed that the oldest adults (OR=1.07 for each additional year of age; 95% CI 1.05 to 1.08) presenting with impaired functional mobility (OR=3.22; 95% CI 2.67 to 3.87), dependency in the activities of daily living (OR=4.62; 95% CI 3.76 to 5.67), cognitive impairment (OR=3.75; 95% CI 3.06 to 4.59) and traumatic injuries (OR=1.58; 95% CI 1.25 to 2.01) had a higher probability of unplanned nursing home admission. The number of International Classification of Diseases, 10th version diagnoses had no significant impact on nursing home admissions, contrarily to the number of prescribed drugs (OR=1.17; 95% CI 1.15 to 1.19). Antiemetics/antinauseants (OR=2.53; 95% CI 1.21 to 5.30), digestives (OR=1.78; 95% CI 1.09 to 2.90), psycholeptics (OR=1.76; 95% CI 1.60 to 1.93), antiepileptics (OR=1.49; 95% CI 1.25 to 1.79) and anti-Parkinson's drugs (OR=1.40; 95% CI 1.12 to 1.75) were strongly linked to unplanned nursing home admission., Conclusions: Numerous risk factors for unplanned nursing home admission were identified. To prevent the adverse health outcomes that precipitate acute hospitalisations and unplanned nursing home admissions, ambulatory care providers should consider these risk factors in their care planning for older adults before they reach a state requiring hospitalisation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Background: identifying drug-related hospital admissions (DRAs) in older people is difficult. A standardised chart review procedure has recently been developed. It includes an adjudication team (physician and pharmacist) screening using 26 triggers and then performing causality assessment to determine whether an adverse drug event (ADE) occurred (secondary to an adverse drug reaction, overuse, misuse or underuse) and whether the ADE contributed to hospital admission (DRA)., Objective: to assess the performance of those triggers in detecting DRA., Design: retrospective study using data from the OPERAM (OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people) trial., Settings: four European medical centres., Subjects: multimorbid (≥ 3 chronic medical conditions) older (≥ 70 years) inpatients with polypharmacy (≥ 5 chronic medications) were enrolled in the OPERAM trial (N = 2,008) and followed for 12 months. We included patients with ≥1 adjudicated hospitalisation during the follow-up., Methods: the positive predictive value (PPV; number of DRAs identified by trigger/number of triggers) was calculated for each trigger and for the tool as a whole., Results: of 1,235 hospitalisations adjudicated for 832 patients, 716 (58%) had at least one trigger; an ADE was identified in 673 (54%) and 518 (42%) were adjudicated as DRAs. The overall PPV of the trigger tool for detecting DRAs was 0.66 [0.62-0.69]., Conclusions: this tool performs well for identifying DRAs in older people. Based on our results, a revised version of the tool was proposed but will require external validation before it can be incorporated into research and clinical practice., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: The present study analysed 4 years of a hospital register (2015-2018) to determine the risk of 30-day hospital readmission associated with the medical conditions and drug regimens of polymedicated, older inpatients discharged home., Design: Registry-based cohort study., Setting: Valais Hospital-a public general hospital centre in the French-speaking part of Switzerland., Participants: We explored the electronic records of 20 422 inpatient stays by polymedicated, home-dwelling older adults held in the hospital's patient register. We identified 13 802 hospital readmissions involving 8878 separate patients over 64 years old., Outcome Measures: Sociodemographic characteristics, medical conditions and drug regimen data associated with risk of readmission within 30 days of discharge., Results: The overall 30-day hospital readmission rate was 7.8%. Adjusted multivariate analyses revealed increased risk of hospital readmission for patients with longer hospital length of stay (OR=1.014 per additional day; 95% CI 1.006 to 1.021), impaired mobility (OR=1.218; 95% CI 1.039 to 1.427), multimorbidity (OR=1.419 per additional International Classification of Diseases, 10th Revision condition; 95% CI 1.282 to 1.572), tumorous disease (OR=2.538; 95% CI 2.089 to 3.082), polypharmacy (OR=1.043 per additional drug prescribed; 95% CI 1.028 to 1.058), and certain specific drugs, including antiemetics and antinauseants (OR=3.216 per additional drug unit taken; 95% CI 1.842 to 5.617), antihypertensives (OR=1.771; 95% CI 1.287 to 2.438), drugs for functional gastrointestinal disorders (OR=1.424; 95% CI 1.166 to 1.739), systemic hormonal preparations (OR=1.207; 95% CI 1.052 to 1.385) and vitamins (OR=1.201; 95% CI 1.049 to 1.374), as well as concurrent use of beta-blocking agents and drugs for acid-related disorders (OR=1.367; 95% CI 1.046 to 1.788)., Conclusions: Thirty-day hospital readmission risk was associated with longer hospital length of stay, health disorders, polypharmacy and drug regimens. The drug regimen patterns increasing the risk of hospital readmission were very heterogeneous. Further research is needed to explore hospital readmissions caused solely by specific drugs and drug-drug interactions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Introduction: The persistent fragmentation of home healthcare reflects inadequate coordination between care providers. Still, while factors at the system (e.g., regulations) and organisational (e.g., work environment) levels crucially influence homecare organisation, coordination and ultimately quality, knowledge of these factors and their relationships in homecare settings remains limited., Objectives: This study has three aims: [1] to explore how system-level regulations lead to disparities between homecare agencies' structures, processes and work environments; [2] to explore how system- and organisation-level factors affect agency-level homecare coordination; and [3] to explore how agency-level care coordination is related to patient-level quality of care., Design and Methods: This study focuses on a national multi-center cross-sectional survey in Swiss homecare settings. It will target 100 homecare agencies, their employees and clients for recruitment, with data collection period planned from January to June 2021. We will assess regulations and financing mechanisms (via public records), agency characteristics (via agency questionnaire data) and homecare employees' working environments and coordination activities, as well as staff- and patient-level perceptions of coordination and quality of care (via questionnaires for homecare employees, clients and informal caregivers). All collected data will be subjected to descriptive and multi-level analyses., Discussion: The first results are expected by December 2021. Knowledge of factors linked to quality of care is essential to plan and implement quality improvement strategies. This study will help to identify modifiable factors at multiple health system levels that might serve as access points to improve coordination and quality of care.

Background The shift from inpatient to ambulatory care has resulted in an increase in home care patients. Little is known regarding medication safety associated with patient transfer from hospital to home care. Objective To evaluate medication-related problems in patients transferring from hospital to home care in Switzerland. Setting A non-for-profit home care organization in the city of Lucerne/Switzerland. Methods We conducted a prospective observational study, including patients aged ≥ 64 years and receiving ≥ 4 medications at hospital discharge. Two structured questionnaires assessing the transfer process were completed by home care nurses. Prescription quality was assessed using a PCNE Type 2b Medication Review. Main outcome measures The quality of the transfer process was measured comparing agreed-upon with reported parameters. Prescription quality was analyzed assessing the unambiguity of the prescription. Potentially inappropriate medications (Priscus ® list), contraindications, duplications and interactions, and clinical pharmacist-identified potential medication-related problems were collected. Results Study patients (n = 100) received 8.6 ± 3.5 regularly administered medications. Only 5/100 patients had a complete set of written discharge information. At the time of the first visit, 13/100 patients had no written medication information available. Discharge medication prescriptions were clear to nurses in 62% of patients. In 20 patients, the required medications were unavailable, resulting in 19 medication errors. Assessment by a clinical pharmacist revealed only 33/100 patients had a clear discharge prescription. Of a total of 984 prescribed drugs, 16% were considered to be ambiguous, 22 (2.2%) were potentially inappropriate. 7/984 drugs were contraindicated, 8 were duplicates. Conclusion In addition to the known risk factors in patients transferring from hospital to home care (age, polymedication, multiple providers), 3 major problems impacted upon medication safety: fragmented communication, unreliable medication availability and a poor prescription quality. Clinical pharmacists are an important option to improve medication safety ass.

Introduction While drug-related problems (DRPs) in the inpatient setting are well known, the scope of these problems in home care has not been critically evaluated. Aim of the Review Our primary objective was to evaluate the incidence and demographics of DRPs in home care. Our specific aims were to characterize the rate of potentially inappropriate medications (PIMs), medication errors (MEs) and adverse drug events (ADEs) and to identify risk factors which contribute to DRPs in the home care setting. Methods Pubmed, Embase and CiNAHL databases were systematically searched from January 2000 to December 2016 for all publications which quantitatively characterized DRPs in the home care setting. Results The most commonly reported DRPs characterized in studies were PIMs (n = 16), MEs (n = 4) and the ME-subcategory medication-related discrepancies (n = 7). The frequency of PIMs ranged from 19.8 to 48.4%; up to 26% PIMs were considered severe. Polypharmacy (≥ 9 drugs) and increasing age were the most common risk factors for DRPs. Insufficient interdisciplinary teamwork and inconsistent performance of medication reviews were also risks factors for DRPs. Patients and/or caregivers were responsible for 42.3% of DRPs. Discussion Compared with acute inpatient care, DRPs are more frequently reported in home care. The rate of DRPs varies depending upon the reference used to define the problem. Conclusion Transfer of complete medical records and the use of an interdisciplinary team have the potential to reduce DRPs, including MEs, specifically when integrating a pharmacist providing regular medication review. Importantly, patients and informal caregivers must be significant partners with this interdisciplinary team.

Aim: The aim was to evaluate the impact of staff training and wearing safety vests as a combined intervention on interruptions during medication preparation and double-checking., Background: Interruptions and errors during the medication process are common and an important issue for patient safety in the hospital setting., Methods: We performed a pre- and post-intervention pilot-study using direct structured observation of 26 nurses preparing and double-checking 431 medication doses (225 pre-intervention and 206 post-intervention) for 36 patients (21 pre-intervention and 15 post-intervention)., Results: With staff training and the introduction of safety vests, the interruption rate during medication preparation was reduced from 36.8 to 28.3 interruptions per hour and during double-checking from 27.5 to 15 interruptions per hour., Conclusion: This pilot-study showed that the frequency of interruptions decreased during the critical tasks of medication preparation and double-checking after the introduction of staff training and wearing safety vests as part of a quality improvement process., Implications for Nursing Management: Nursing management should acknowledge interruptions as an important factor potentially influencing medication safety. Unnecessary interruptions can be successfully reduced by considering human and system factors and increasing both staff and nursing managers' awareness of 'interruptive communication practices' and implementing physical barriers. This is the first pilot-study specifically evaluating the impact of staff training and wearing safety vests on the reduction of interruptions during medication preparation and double-checking., (© 2017 John Wiley & Sons Ltd.)

Background: While drug-related problems are among the most frequent adverse events in health care, little is known about their type and prevalence in home care in the current literature. The use of a Critical Incident Reporting System (CIRS), known as an economic and efficient tool to record medication errors for subsequent analysis, is widely implemented in inpatient care, but less established in ambulatory care. Recommendations on a possible format are scarce. A manual CIRS was developed based on the literature and subsequently piloted and implemented in a Swiss home care organization. Aim: The aim of this work was to implement a critical incident reporting system specifically for medication safety in home care. Results: The final CIRS form was well accepted among staff. Requiring limited resources, it allowed preliminary identification and trending of medication errors in home care. The most frequent error reports addressed medication preparation at the patients’ home, encompassing the following errors: omission (30 %), wrong dose (17.5 %) and wrong time (15 %). The most frequent underlying causes were related to working conditions (37.9 %), lacking attention (68.2 %), time pressure (22.7 %) and interruptions by patients (9.1 %). Conclusions: A manual CIRS allowed efficient data collection and subsequent analysis of medication errors in order to plan future interventions for improvement of medication safety. The development of an electronic CIRS would allow a reduction of the expenditure of time regarding data collection and analysis. In addition, it would favour the development of a national CIRS network among home care institutions.

Background: Foreign-language (FL) patients are at increased risk for adverse drug events. Evidence regarding communication barriers and the safety of pharmaceutical care of FL patients in European countries is scarce despite large migrant populations., Objective: To investigate Swiss public pharmacists' experiences and current practices in counselling FL patients with a focus on patient safety., Method: In a cross-sectional study heads of public pharmacies in Switzerland were surveyed using an electronic questionnaire., Main Outcome Measure: The survey assessed the frequency of communication barriers encountered in medication counselling of FL patients, perceptions of risks for adverse drug events, satisfaction with the quality of counselling provided to FL patients, current strategies to reduce risks, and preferences towards tools to improve safety for FL patients., Results: 498 pharmacists completed the survey (43 % response rate). More than every second pharmacist reported at least weekly encounters at which they cannot provide good medication counselling to FL patients in the regional Swiss language. Ad-hoc interpreting by minors is also common at a considerable number of pharmacies (26.5 % reported at least one weekly occurrence). Approximately 10 % of pharmacies reported that they fail at least weekly to explain the essentials of drug therapy (e.g. dosing of children's medications) to FL patients. 79.8 % perceived the risk of FL patients for adverse drug events to be somewhat or much higher compared to other patients. 22.5 % of pharmacists reported being concerned at least monthly about medication safety when FL patients leave their pharmacy. However, the majority of pharmacists were satisfied with the quality of care provided to FL patients in their pharmacy [78.6 % (very) satisfied]. The main strategy used to improve counselling for FL patients was the employment of multilingual staff. Participants would use software for printing foreign-language labels (41.2 %) and multilingual package inserts (42.0 %) if these were available., Conclusion: Communication barriers with FL patients are frequent in Swiss pharmacies and pharmacists perceive FL patients to be at increased risk for adverse drug events. Development and dissemination of communication tools are needed to support pharmacists in counselling of a diverse migrant population.

Medication errors are responsible for up to 50% of errors in healthcare. Therefore, they are an important target for the improvement of patient safety. The application of evidence-based methods for the analysis of institution-specific medication safety hotspots is crucial. Recommended methods for the identification of medication safety problems have individual strengths and weaknesses, but there is little overlap. Consequently, a combination of methods is recommended. While the analysis of critical incident reporting systems preferentially identifies serious medication errors, trigger tool represents an effective and cost-efficient approach. Evidence-based data for improvement methods is limited. However, the implementation of clinical pharmacy services, IT tools (electronic prescribing, barcoding) and standardized double-check showed a significant impact on error reduction. In addition, the support of institutional leadership is an important prerequisite.

Background: Starting in 2007, regulatory agencies strengthened label warnings for intravenous haloperidol. Based on adverse drug reaction (ADR) reports of QT prolongation and torsades de pointes, regulatory agencies recommended the use of continuous telemetry or advising against the intravenous administration in general. Intravenous haloperidol is commonly used as a first line treatment for acute delirium. Consequently, the extended warning has caused uncertainty among health care professionals., Objective: The aim of this study is to critically evaluate the WHO global individual case safety report (ICSR) database VigiBase for QT prolongation, torsades and/or cardiac arrest involving intravenous haloperidol compared to other routes of administration and the antipsychotics olanzapine and quetiapine., Method: All WHO safety reports (1972-2010) of cardiac reactions associated with haloperidol, quetiapine and olanzapine were evaluated, including dose, route of administration and patient risk factors. Reporting odds ratios for the 3 antipsychotics were calculated. Main outcome measure Number of submitted reports on different antipsychotics., Results: The absolute number of ICSR regarding QT prolongation, torsades and/or cardiac arrest were: haloperidol (365 cases), olanzapine (489) and quetiapine (520). Reporting rates of haloperidol did not increase over the last two decades. 32% of the haloperidol cases involved oral, 16.4% intramuscular and 22.7% intravenous administration. The difference of the reporting odds ratios of haloperidol and quetiapine were not statistically significant. Olanzapine was associated with a slightly lower reporting odds ratio., Conclusion: While regulatory agencies advise against the use of intravenous haloperidol, review of VigiBase does not reveal that the intravenous route is any more likely to be associated with cardiac adverse events. Furthermore, our results do not demonstrate any additional risk associated with haloperidol when compared with alternative agents. Although pharmacovigilance data does not routinely include a denominator regarding frequency of use, regulatory agencies are currently advising against the use of intravenous haloperidol based on pharmacovigilance, but the number of overall reports is greater for quetiapine and olanzapine when compared to haloperidol. Improved pharmacovigilance approaches are needed to more accurately address the safe, effective use of medicines.

Purpose: The accuracy, efficiency, and efficacy of four commonly recommended medication safety assessment methodologies were systematically reviewed., Methods: Medical literature databases were systematically searched for any comparative study conducted between January 2000 and October 2009 in which at least two of the four methodologies-incident report review, direct observation, chart review, and trigger tool-were compared with one another. Any study that compared two or more methodologies for quantitative accuracy (adequacy of the assessment of medication errors and adverse drug events) efficiency (effort and cost), and efficacy and that provided numerical data was included in the analysis., Results: Twenty-eight studies were included in this review. Of these, 22 compared two of the methodologies, and 6 compared three methods. Direct observation identified the greatest number of reports of drug-related problems (DRPs), while incident report review identified the fewest. However, incident report review generally showed a higher specificity compared to the other methods and most effectively captured severe DRPs. In contrast, the sensitivity of incident report review was lower when compared with trigger tool. While trigger tool was the least labor-intensive of the four methodologies, incident report review appeared to be the least expensive, but only when linked with concomitant automated reporting systems and targeted follow-up., Conclusion: All four medication safety assessment techniques-incident report review, chart review, direct observation, and trigger tool-have different strengths and weaknesses. Overlap between different methods in identifying DRPs is minimal. While trigger tool appeared to be the most effective and labor-efficient method, incident report review best identified high-severity DRPs.

Background: In September 2007, the Food and Drug Administration (FDA) strengthened label warnings for intravenous (IV) haloperidol regarding QT prolongation (QTP) and torsades de pointes (TdP) in response to adverse event reports. Considering the widespread use of IV haloperidol in the management of acute delirium, the specific FDA recommendation of continuous electrocardiogram (ECG) monitoring in this setting has been associated with some controversy. We reviewed the evidence for the FDA warning and provide a potential medical center response to this warning., Methods: Cases of intravenous haloperidol-related QTP/TdP were identified by searching PubMed, EMBASE, and Scopus databases (January 1823 to April 2009) and all FDA MedWatch reports of haloperidol-associated adverse events (November 1997 to April 2008)., Results: A total of 70 of IV haloperidol-associated QTP and/or TdP were identified. There were 54 reports of TdP; 42 of these events were reportedly preceded by QTP. When post-event QTc data were reported, QTc was prolonged >450 msec in 96% of cases. Three patients experienced sudden cardiac arrest. Sixty-eight patients (97%) had additional risk factors for TdP/prolonged QT, most commonly receipt of concomitant proarrhythmic agents. Patients experiencing TdP received a cumulative dose of 5 mg to 645 mg, patients with QTP alone received a cumulative dose of 2 mg to 1540 mg., Conclusions: While administration of IV haloperidol can be associated with QTP/TdP, this complication most often took place in the setting of concomitant risk factors. Importantly, the available data suggest that a total cumulative dose of IV haloperidol of <2 mg can safely be administered without ongoing electrocardiographic monitoring in patients without concomitant risk factors., ((c) 2010 Society of Hospital Medicine.)

Background: Topical thrombins are active hemostatic agents that can be used to minimize blood loss during surgery. Before 2007, the only topical thrombins available were derived from bovine plasma. Antibody formation to bovine thrombin and/or factor V, with subsequent risk of cross-reactivity with human factor V, and hemorrhagic complications associated with human factor-V deficiencies have been described in case reports of surgeries in which bovine thrombins were used. This risk is now included in the boxed warning section of the bovine thrombin prescribing information. In 2007 and 2008, 2 new topical thrombins from nonbovine sources received approval for use from the US Food and Drug Administration. The 3 active topical thrombins that are currently marketed are bovine plasma-derived thrombin, human plasma-derived thrombin, and human recombinant thrombin., Objective: The purpose of this review was to evaluate the literature on the efficacy and safety of topical thrombins and discuss the pharmacoeconomic considerations associated with their use., Methods: PubMed, EMBASE, and International Pharmaceutical Abstracts were searched for relevant papers published in English through October 10,2008, using the terms thrombin, human recombinant thrombin, bovine thrombin, plasma derived thrombin, and topical thrombin. Manufacturer-provided materials were also reviewed. Abstracts and unpublished data, as well as evaluations of sealants, adhesives, glues, and other hemostats that contain thrombin mixed with fibrinogen and other clotting factors, were excluded., Results: Four randomized, double-blind studies involving the active, stand-alone topical thrombins were found. The bovine thrombin involved in these studies was the predecessor to the currently marketed, highly purified bovine formulation. No studies comparing the human products, studies involving the highly purified bovine preparation, or placebo-controlled studies involving bovine thrombin were found. In a Phase III comparison of human recombinant thrombin and bovine thrombin, the percentages of patients who achieved hemostasis within 10 minutes of topical thrombin application were 95.4% and 95.1%, respectively (95% CI, -3.7 to 5.0). The incidence of hemostasis within 10 minutes was also similar in a Phase III comparison of human plasma-derived thrombin and bovine thrombin (both, 97.4% [95% CI, 0.96 to 1.05]). In the study that compared human recombinant and bovine thrombin, the incidence of antiproduct antibody formation was 21.5% (43/200) in the bovine thrombin group and 1.5% (3/198) in the human recombinant thrombin group (P < 0.001); patients with antibodies to bovine thrombin had numerically higher incidences of bleeding or thromboembolic events than did patients without these antibodies (19% vs 13%; P value not reported). Human plasma-derived thrombin is available as a frozen sterile solution that must be thawed before application, whereas the human recombinant and bovine plasma-derived products are supplied as unrefrigerated sterile powders that must be reconstituted before use. The human thrombins are more costly than bovine thrombin on a per-vial basis. The average wholesale prices (US $, 2008) for 5000-IU vials of bovine thrombin and human recombinant thrombin were $87.85 and $103.20, respectively; the average wholesale price for a 4000- to 6000-IU vial of human plasma-derived thrombin was $96.00., Conclusions: Topical thrombins vary in the ways in which they are manufactured and their safety profiles, storage requirements, and costs. Human recombinant thrombin and human plasma-derived thrombin have each been shown to have hemostatic efficacy comparable to that of bovine thrombin. Bovine thrombin carries the risk of formation of cross-reactive antibodies to bovine thrombin, factor V, and other impurities that may be present in these formulations. Immunogenicity data for the currently marketed, highly purified bovine thrombin relative to older formulations of bovine thrombin could not be found. Whether the potential safety advantage justifies the added cost of the human products remains to be established.

Interactions between immunosuppressants and antiinfectives are most important in pharmacotherapy. Patients receiving this drug combination must be monitored carefully. Individual dose adaptation and therapeutic drug monitoring (TDM) according to the SOAP scheme (subjective data, objective data, analysis, plan) are exemplified by the case report of a 47-year-old patient who had undergone a liver transplantation.