Event Analysis for Automated Estimation of Absent and Persistent Medication Alerts: Novel Methodology.

Background: Event analysis is a promising approach to estimate the acceptance of medication alerts issued by computerized physician order entry (CPOE) systems with an integrated clinical decision support system (CDSS), particularly when alerts cannot be interactively confirmed in the CPOE-CDSS due to its system architecture. Medication documentation is then reviewed for documented evidence of alert acceptance, which can be a time-consuming process, especially when performed manually. Objective: We present a new automated event analysis approach, which was applied to a large data set generated in a CPOE-CDSS with passive, noninterruptive alerts. Methods: Medication and alert data generated over 3.5 months within the CPOE-CDSS at Heidelberg University Hospital were divided into 24-hour time intervals in which the alert display was correlated with associated prescription changes. Alerts were considered "persistent" if they were displayed in every consecutive 24-hour time interval due to a respective active prescription until patient discharge and were considered "absent" if they were no longer displayed during continuous prescriptions in the subsequent interval. Results: Overall, 1670 patient cases with 11,428 alerts were analyzed. Alerts were displayed for a median of 3 (IQR 1-7) consecutive 24-hour time intervals, with the shortest alerts displayed for drug-allergy interactions and the longest alerts displayed for potentially inappropriate medication for the elderly (PIM). Among the total 11,428 alerts, 56.1% (n=6413) became absent, most commonly among alerts for drug-drug interactions (1915/2366, 80.9%) and least commonly among PIM alerts (199/499, 39.9%). Conclusions: This new approach to estimate alert acceptance based on event analysis can be flexibly adapted to the automated evaluation of passive, noninterruptive alerts. This enables large data sets of longitudinal patient cases to be processed, allows for the derivation of the ratios of persistent and absent alerts, and facilitates the comparison and prospective monitoring of these alerts.

[Quality of medication documentation in patients discharge summaries after implementing new legal requirements]. / Dokumentationsqualität der Medikation in Entlassbriefen ­ eine Bestandsaufnahme nach Einführung des Rahmenvertrags Entlassmanagement.

INTRODUCTION: Discharge from hospital is a risk to drug continuity and medication safety. In Germany, new legal requirements concerning the management of patient discharge from the hospital came into force in 2017. They set minimum requirements for the documentation of medications in patient discharge summaries, which are the primary means of communication at transitions of care. Six years later, data on their practical implementation in routine care are lacking. METHODS: Within the scope of an explorative retrospective observational study, the minimum requirements were operationalized and a second set of assessment criteria was derived from the recommendation "Good Prescribing Practice in Drug Therapy" published by the Aktionsbündnis Patientensicherheit e.V. as a comparative quality standard. A sample of discharge summaries was drawn from routine care at the University Hospital Heidelberg and assessed according to their fulfilment of the criteria sets. In addition, the potential influence of certain context factors (e. g., involvement of clinical pharmacists or software usage) was evaluated. RESULTS: In total, 11 quality criteria were derived from the minimum requirements. According to the eligibility criteria (i. e., three or more discharge medications) 352 discharge summaries (42 wards; issued in May-July 2021), containing in total 3,051 medications, were included. The practical implementation of the minimum requirements for documenting medications in patient discharge summaries differed considerably depending on the criterion and defined context factors. Core elements (i. e., drug name, strength, and dosage at discharge) were fulfilled in 82.8 %, while further minimum requirements were rarely met or completely lacking (e. g., explanations for special pharmaceutical forms). Involvement of clinical pharmacists and usage of software were shown to be a facilitator of documentation quality, while on-demand medication (compared to long-term medication) as well as newly prescribed medication (compared to home medication or medication changed during hospitalisation) showed poorer documentation quality. In addition, the documentation quality seemed to depend on the department and the day of discharge. CONCLUSION: To date, the wording of the German legal requirements allows for different interpretations without considering the respective clinical setting and the medication actually prescribed. For future clarification of the requirements, implications of the wording for the clinical setting should be considered.

Exploring the heterogeneity in community pharmacist-led medication review studies - A systematic review.

BACKGROUND: Findings on the effectiveness of medication reviews led by community pharmacists (CPs) are often inconclusive. It has been hypothesized that studies are not sufficiently standardized, and thus, it is difficult to draw conclusions. OBJECTIVE(S): To examine differences in the way CP-led medication review studies are set up. This was accomplished by investigating (1) patient selection criteria, (2) components of the medication review interventions, (3) types of outcomes, and (4) measurement instruments used. METHODS: A systematic literature search of randomized controlled trials of CP-led medication reviews was carried out in PubMed and Cochrane Library. Information on patient selection, intervention components, and outcome measurements was extracted, and frequencies were analyzed. Where possible, outcomes were mapped to the Core Outcome Set (COS) for medication review studies. Finally, a network analysis was conducted to explore the influence of individual factors on outcome effects. RESULTS: In total, 30 articles (26 studies) were included. Most articles had a drug class-specific or disease-specific patient selection criterion (n = 19). Half of the articles included patients aged ≥60 years (n = 15), and in 40% (n = 12/30) patients taking 4 drugs or more. In 24 of 30 articles, a medication review was comprised with additional interventions, such as distribution of educational material and training or follow-up visits. About 40 different outcomes were extracted. Within specific outcomes, the measurement instruments varied, and COS was rarely represented. CONCLUSION: The revealed differences in patient selection, intervention delivery, and outcome assessment highlight the need for more standardization in research on CP-led medication reviews. While intervention delivery should be more precisely described to capture potential differences between interventions, outcome assessment should be standardized in terms of outcome selection by application of the COS, and with regard to the selected core outcome measurement instruments to enable comparison of the results.

Approaches to medication history taking in different hospital settings: A scoping review.

PURPOSE: A comprehensive medication history can contribute to safe therapy. Many approaches aiming to improve medication history taking require significant human resources. To design an efficient process that delivers high-quality medication histories, the individual requirements and resources of a given setting need to be considered. We aimed to provide an overview of existing approaches to medication history taking and their performance in different settings to potentially support the selection of an appropriate procedure. METHODS: We searched 3 literature databases (PubMed/MEDLINE, CINAHL, PsycINFO) for publications on approaches to medication history taking and analyzed them with regard to their key components as well as the setting, patient population, assessed outcomes, and efficacy. RESULTS: In total, 65 publications were included and analyzed. The majority of the reported approaches relied on involvement of dedicated staff (n = 43), followed by process-oriented interventions (eg, checklists; n = 15) and information technology (IT)-guided interventions (n = 11). A mean (SD) of 6 (2.9) outcomes were described in each study. Medication discrepancies were reported in 89% of all studies, yet about 75 different descriptions of this outcome were used, making it difficult to compare study results. Only 11 studies applied a sample size calculation and statistical tests. Of those, 10 reported a positive effect of their respective intervention on the quality of medication histories. CONCLUSION: Most approaches focused on pharmacy staff, which are associated with considerable cost and resources. Therefore, IT-based approaches and patient engagement should be investigated as cost-effective alternatives and tested for superiority in the same setting. Reporting guidelines and standardized methodology are needed to improve the comparability of such studies.

Informational continuity of medication management in transitions of care: Qualitative interviews with stakeholders from the HYPERION-TransCare study.

BACKGROUND: The transition of patients between inpatient and outpatient care can lead to adverse events and medication-related problems due to medication and communication errors, such as medication discontinuation, the frequency of (re-)hospitalizations, and increased morbidity and mortality. Older patients with multimorbidity and polypharmacy are particularly at high risk during transitions of care. Previous research highlighted the need for interventions to improve transitions of care in order to support information continuity, coordination, and communication. The HYPERION-TransCare project aims to improve the continuity of medication management for older patients during transitions of care. METHODS AND FINDINGS: Using a qualitative design, 32 expert interviews were conducted to explore the perspectives of key stakeholders, which included healthcare professionals, patients and one informal caregiver, on transitions of care. Interviews were conducted between October 2020 and January 2021, transcribed verbatim and analyzed using content analysis. We narratively summarized four main topics (stakeholders' tasks, challenges, ideas for solutions and best practice examples, and patient-related factors) and mapped them in a patient journey map. Lacking or incomplete information on patients' medication and health conditions, inappropriate communication and collaboration between healthcare providers within and across settings, and insufficient digital support limit the continuity of medication management. CONCLUSIONS: The study confirms that medication management during transitions of care is a complex process that can be compromised by a variety of factors. Legal requirements and standardized processes are urgently needed to ensure adequate exchange of information and organization of medication management before, during and after hospital admissions. Despite the numerous barriers identified, the findings indicate that involved healthcare professionals from both the inpatient and outpatient care settings have a common understanding.

[General practice care for patients with chronic non-cancer pain: A rapid review as part of the RELIEF project]. / Hausärztliche Versorgung von Patient:innen mit chronischen nicht-tumorbedingten Schmerzen: ein Rapid Review im Rahmen des RELIEF-Projekts.

INTRODUCTION: Approximately one fifth of the German population suffers from chronic pain, which is often associated with limitations in coping with everyday life, social isolation and psychological comorbidities such as anxiety and depression. The importance of a treatment approach that considers biological, psychological, and social factors (bio-psycho-social model) as well as non-drug interventions is emphasized in current guidelines, but presents challenges for primary care practices. To support the implementation of evidence-based best practice recommendations, the RELIEF project (Resource-oriented case management to implement recommendations for patients with chronic pain and frequent use of analgesics in general practices) aims to develop a case management program for the primary care of patients with chronic non-tumor pain. METHODS: Prior to intervention development, a rapid review was conducted to identify best practice recommendations for the care of patients with chronic non-tumor pain, barriers and strategies to their implementation, and gaps in care in current guidelines and literature. Selective searches of guidelines, PubMed, the Cochrane Library, bibliographies of relevant publications, and the gray literature focused on assessment and monitoring, education, promotion of self-care, and rational pharmacotherapy. RESULTS: Numerous recommendations on assessment and monitoring were identified, but only a few studies examined their feasibility in primary care practices. Guidelines contained few specific recommendations on content and format of patient education on chronic pain. Recommendations for non-drug self-care measures were mainly related to physical activity, relaxation techniques, behavioral therapy techniques and external applications. Especially for the area of physical activity, numerous barriers but also strategies for a successful implementation could be identified. DISCUSSION: In a potential primary care model for patients with chronic non-tumor pain, pain assessment should aim to identify patients who need support in implementing medication and non-medication interventions in the primary care setting and/or could benefit from specialized care. To implement recommendations for pain education, primary care physicians need educational materials in a variety of formats and levels of detail that ideally could be processed by patients at home and then get addressed in practices using simple key questions. Non-drug measures should be an explicit part of the treatment plan. CONCLUSION: Many of the identified recommendations for the treatment of patients with chronic non-tumor pain can also be considered relevant for the primary care setting. Specific guidelines and concepts for primary care physicians that include setting-specific characteristics at the physician, patient, and system levels would be desirable for a successful implementation of these recommendations.

Development and Pilot Testing of an Algorithm-Based Approach to Anticholinergic Deprescribing in Older Patients.

BACKGROUND: Adverse anticholinergic drug reactions are common, yet evidence on how to reduce exposure to anticholinergic activity and reliably measure successful deprescribing is still scant. This study proposes an algorithm-based approach to evaluate and reduce anticholinergic load, and reports the results of its pilot testing. METHODS: Based on published evidence and expert opinion, a list of 85 anticholinergic drugs and 21 algorithms for reducing anticholinergic load, e.g., by recommending alternative drugs with lower risk, were developed. An accompanying test battery was assembled by focusing on instruments that sensitively reflect anticholinergic load and may be sensitive to depict changes (Neuropsychological Assessment Battery to measure memory and attention, validated assessments for constipation, urinary symptoms, and xerostomia, as well as blood biomarkers). The approach was pilot-tested in a geriatric rehabilitation unit, with clinician feedback as the primary outcome and characterization of anticholinergic symptoms as the secondary outcome. The intervention was delivered by a pharmacist and a clinical pharmacologist who used the algorithms to generate personalized recommendation letters. RESULTS: We included a total of 20 patients, 13 with anticholinergic drugs and 7 without. Recommendations were made for 22 drugs in nine patients from the intervention group, of which seven letters (78%) were considered helpful and 8/22 (36%) anticholinergic drugs were discontinued, reducing anticholinergic load in seven patients. In contrast to patients without drug change, memory assessment in patients with reduced anticholinergic load improved significantly after 2 weeks (6 ± 3 vs. -1 ± 6 points). CONCLUSIONS: The approach was well received by the participating physicians and might support standardized anticholinergic deprescribing.

A multidomain intervention against cognitive decline in an at-risk-population in Germany: Results from the cluster-randomized AgeWell.de trial.

INTRODUCTION: We investigated the effectiveness of a multidomain intervention to preserve cognitive function in older adults at risk for dementia in Germany in a cluster-randomized trial. METHODS: Individuals with a Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) risk score ≥ 9 aged 60 to 77 years were recruited. After randomization of their general practitioner (GP), patients received a multidomain intervention (including optimization of nutrition and medication, and physical, social, and cognitive activity) or general health advice and GP treatment as usual over 24 months. Primary outcome was global cognitive performance (composite z score, based on domain-specific neuropsychological tests). RESULTS: Of 1030 participants at baseline, n = 819 completed the 24-month follow-up assessment. No differences regarding global cognitive performance (average marginal effect = 0.010, 95% confidence interval: -0.113, 0.133) were found between groups at follow-up. Perceived restrictions in intervention conduct by the COVID-19 pandemic did not impact intervention effectiveness. DISCUSSION: The intervention did not improve global cognitive performance. HIGHLIGHTS: Overall, no intervention effects on global cognitive performance were detected. The multidomain intervention improved health-related quality of life in the total sample. In women, the multidomain intervention reduced depressive symptoms. The intervention was completed during the COVID-19 pandemic.

Implementation and evaluation of a complex intervention to improve information availability at the interface between inpatient and outpatient care in older patients with multimorbidity and polypharmacy (HYPERION-TransCare) - study protocol for a pilot and feasibility cluster-randomized controlled trial in general practice in Germany.

BACKGROUND: Despite attempts to improve the cross-sectoral flow of information, difficulties remain in routine healthcare. The resulting negative impact on continuity of care is often associated with poor health outcomes, especially in older patients. Our intervention aims to increase information availability with respect to medications and health conditions at the interface between inpatient and outpatient care and to contribute towards improving the quality of care in older patients. This pilot study focuses on feasibility and implementability. METHODS: The idea of the complex intervention has been developed in a previous study. This intervention will be tested in a prospective, multicenter, cluster-randomized (via web tool), controlled pilot trial with two parallel study arms (intervention and control group). The pilot study will be conducted in 20 general practices in Hesse and Saxony (Germany) and include 200 patients (≥ 65 years of age with multimorbidity and polypharmacy) recruited by the practices. Practice staff and patients will be blinded. We will use qualitative and quantitative methods to assess the feasibility and implementability of the intervention and the study design in a process evaluation covering topics ranging from expectations to experiences. In addition, the feasibility of proposed outcome parameters for the future definitive trial will be explored. The composite endpoint will include health-related patient outcomes (hospitalization, falls, and mortality using, e.g., the FIMA questionnaire), and we will assess information on medications (SIMS questionnaire), symptoms and side effects of the medication (pro-CTCAE questionnaire), and health literacy (HLQ questionnaire). Data will be collected at study begin (baseline) and after 6 months. Furthermore, the study will include surveys and interviews with patients, general practitioners, and healthcare assistants. DISCUSSION: The intervention was developed using a participatory approach involving stakeholders and patients. It aims to empower general practice teams as they provide patient-centered care and play a key role in the coordination and continuity of care. We aim to encourage patients to adopt an active role in their health care. Overall, we want to increase the availability of health-related information for patients and healthcare providers. The results of the pilot study will be used in the design and implementation of the future definitive trial. TRIAL REGISTRATION: The study was registered in DRKS-German Clinical Trials Register: registration number DRKS00027649 (date: 19 January 2022). Date and version identifier 10.07.2023; Version 1.3.

Workflow, Time Requirement, and Quality of Medication Documentation with or without a Computerized Physician Order Entry System-A Simulation-Based Lab Study.

BACKGROUND: The introduction of a computerized physician order entry (CPOE) system is changing workflows and redistributing tasks among health care professionals. OBJECTIVES: The aim of this study is to describe exemplary changes in workflow, to objectify the time required for medication documentation, and to evaluate documentation quality with and without a CPOE system (Cerner® i.s.h.med). METHODS: Workflows were assessed either through direct observation and in-person interviews or through semistructured online interviews with clinical staff involved in medication documentation. Two case scenarios were developed consisting of exemplary medications (case 1 = 6 drugs and case 2 = 11 drugs). Physicians and nurses/documentation assistants were observed documenting the case scenarios according to workflows established prior to CPOE implementation and those newly established with CPOE implementation, measuring the time spent on each step in the documentation process. Subsequently, the documentation quality of the documented medication was assessed according to a previously established and published methodology. RESULTS: CPOE implementation simplified medication documentation. The overall time needed for medication documentation increased from a median of 12:12 min (range: 07:29-21:10 min) without to 14:40 min (09:18-25:18) with the CPOE system (p = 0.002). With CPOE, less time was spent documenting peroral prescriptions and more time documenting intravenous/subcutaneous prescriptions. For physicians, documentation time approximately doubled, while nurses achieved time savings. Overall, the documentation quality increased from a median fulfillment score of 66.7% without to 100.0% with the CPOE system (p < 0.001). CONCLUSION: This study revealed that CPOE implementation simplified the medication documentation process but increased the time spent on medication documentation by 20% in two fictitious cases. This increased time resulted in higher documentation quality, occurred at the expense of physicians, and was primarily due to intravenous/subcutaneous prescriptions. Therefore, measures to support physicians with complex prescriptions in the CPOE system should be established.

Mortality and Hospitalizations Among Patients Enrolled in an Interprofessional Medication Management Program.

BACKGROUND: Measures for improving medication safety in outpatient care are often complex and involve medication reviews. Over the period 2016-2022 (with a preceeding one-year pilot phase), an interprofessional medication management program- the Medicines Initiative Saxony-Thuringia (Arzneimittelinitiative Sachsen-Thüringen, ARMIN)-was implemented in two German federal states. More than 5000 patients received a medication review by the end of 2019 by a team composed of physicians and pharmacists and were provided with joint, continuous care thereafter. METHODS: In the framework of a retrospectively registered cohort study, the mortality and hospitalizations of this population (5033 patients) were studied using routine data from a statutory health insurer (observation period 2015-2019) and compared with those of a control group (10 039 patients) determined from the routine data by propensity score matching. Mortality was compared by survival analysis (Cox regression), and hospitalization rates were compared in terms of event probabilities within two years of enrollment in the medication management program. Robustness was tested in multiple sensitivity analyses. RESULTS: Over the observation period, 9.3% of the ARMIN participants and 12.9% of persons in the control group died (hazard ratio of the adjusted Cox regression, 0.84; 95% confidence interval [0.76; 0.94], P = 0.001). In the first two years after inclusion, the ARMIN participants were hospitalized just as often as the persons in the control group (52.4% versus 53.4%; odds ratio from the adjusted model, 1.04 [0.96; 1.11], P = 0.347). The effects were consistent in sensitivity analyses. CONCLUSION: In this retrospective cohort study, participation in the ARMIN program was associated with a lower risk of death. Exploratory analyses provide clues to the potential origin of this association.

Attitudes of non-participating general practitioners and community pharmacists towards interprofessional medication management in primary care: an interview study.

BACKGROUND: Interprofessional medication management in primary care is a recognized strategy for improving medication safety, but it is poorly implemented in Germany. As a pilot project, ARMIN [Arzneimittelinitiative Sachsen-Thüringen] was initiated in 2014 to establish better interprofessional medication management between general practitioners and community pharmacists. AIM: The aim of this study was to explore the views of non-participating general practitioners and community pharmacists towards interprofessional medication management within ARMIN and to identify barriers to participation. METHOD: This was an interview study comprising a series of semi-structured telephone interviews. In total, 36 general practitioners and 15 community pharmacists were interviewed in the period between March and June 2020. Data were analyzed using thematic analysis as an inductive approach and the consolidated framework for implementation research as a deductive approach. RESULTS: Many general practitioners and community pharmacists had a generally positive attitude towards interprofessional medication management. However, various barriers were identified and categorized into five major themes: (I) collaboration between general practitioners and community pharmacists, e.g. concerning general practitioners' professional sovereignty and pharmacists' fear of jeopardizing their relationship with general practitioners when interfering in therapy; (II) eligibility for participation, e.g., the fact that patients had to be insured with a specific statutory health insurance fund; (III) local circumstances, e.g. many pharmacists could not find a collaborating general practitioner (and vice versa). Moreover, patient demand was low, probably because patients were not aware of the program; (IV) information technology, e.g. concerning the lack of available software and data security concerns; and (V) cost-benefit ratio, e.g. the fact that potential benefits were outweighed by program-associated costs. CONCLUSION: The perceived discrepancy between positive attitudes and multiple prevalent barriers indicates considerable potential for further interprofessional collaboration between general practitioners and community pharmacists.

Development of an Electronic Tool to Assess Patient Preferences in Geriatric Polypharmacy (PolyPref).

Purpose: Medical decision-making in older adults with multiple chronic conditions and polypharmacy should include the individual patient's treatment preferences. We developed and pilot-tested an electronic instrument (PolyPref) to elicit patient preferences in geriatric polypharmacy. Patients and Methods: PolyPref follows a two-stage direct approach to preference assessment. Stage 1 generates an individual preselection of relevant health outcomes and medication regimen characteristics, followed by stage 2, in which their importance is assessed using the Q-sort methodology. The feasibility of the instrument was tested in adults aged ≥70 years with ≥2 chronic conditions and regular intake of ≥5 medicines. After the assessment with PolyPref, the patients rated the tool with regard to its comprehensibility and usability and assessed the accuracy of the personal result. Evaluators rated the patients' understanding of the task. Results: Eighteen short-term health outcomes, 3 long-term health outcomes, and 8 medication regimen characteristics were included in the instrument. The final population for the pilot study comprised 15 inpatients at a clinic for geriatric rehabilitation with a mean age of 80.6 (± 6.0) years, a median score of 28 (range 25-30) points on the Mini-Mental State Examination, and a mean of 11.6 (± 3.6) regularly taken medicines. Feedback by the patients and the evaluators revealed ratings in favor of understanding and comprehensibility of 86.7% to 100%. The majority of the patients stated that their final result summarized the most important aspects of their pharmacotherapy (93.3%) and that its ranking order reflected their personal opinion (100%). Preference assessment took an average of 35 (± 8.5) min, with the instrument being handled by the evaluator in 14 of the 15 participants. Conclusion: Preference assessment with PolyPref was feasible in older adults with multiple chronic conditions and polypharmacy, offering a new strategy for the standardized evaluation of patient priorities in geriatric pharmacotherapy.

Modulators Influencing Medication Alert Acceptance: An Explorative Review.

OBJECTIVES: Clinical decision support systems (CDSSs) use alerts to enhance medication safety and reduce medication error rates. A major challenge of medication alerts is their low acceptance rate, limiting their potential benefit. A structured overview about modulators influencing alert acceptance is lacking. Therefore, we aimed to review and compile qualitative and quantitative modulators of alert acceptance and organize them in a comprehensive model. METHODS: In accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline, a literature search in PubMed was started in February 2018 and continued until October 2021. From all included articles, qualitative and quantitative parameters and their impact on alert acceptance were extracted. Related parameters were then grouped into factors, allocated to superordinate determinants, and subsequently further allocated into five categories that were already known to influence alert acceptance. RESULTS: Out of 539 articles, 60 were included. A total of 391 single parameters were extracted (e.g., patients' comorbidity) and grouped into 75 factors (e.g., comorbidity), and 25 determinants (e.g., complexity) were consequently assigned to the predefined five categories, i.e., CDSS, care provider, patient, setting, and involved drug. More than half of all factors were qualitatively assessed (n = 21) or quantitatively inconclusive (n = 19). Furthermore, 33 quantitative factors clearly influenced alert acceptance (positive correlation: e.g., alert type, patients' comorbidity; negative correlation: e.g., number of alerts per care provider, moment of alert display in the workflow). Two factors (alert frequency, laboratory value) showed contradictory effects, meaning that acceptance was significantly influenced both positively and negatively by these factors, depending on the study. Interventional studies have been performed for only 12 factors while all other factors were evaluated descriptively. CONCLUSION: This review compiles modulators of alert acceptance distinguished by being studied quantitatively or qualitatively and indicates their effect magnitude whenever possible. Additionally, it describes how further research should be designed to comprehensively quantify the effect of alert modulators.

Task sharing in an interprofessional medication management program - a survey of general practitioners and community pharmacists.

BACKGROUND: Pharmacist-led medication review and medication management programs (MMP) are well-known strategies to improve medication safety and effectiveness. If performed interprofessionally, outcomes might even improve. However, little is known about task sharing in interprofessional MMP, in which general practitioners (GPs) and community pharmacists (CPs) collaboratively perform medication reviews and continuously follow-up on patients with designated medical and pharmaceutical tasks, respectively. In 2016, ARMIN (Arzneimittelinitiative Sachsen-Thüringen) an interprofessional MMP was launched in two German federal states, Saxony and Thuringia. The aim of this study was to understand how GPs and CPs share tasks in MMP when reviewing the patients' medication. METHODS: This was a cross-sectional postal survey among GPs and CPs who participated in the MMP. Participants were asked who completed which MMP tasks, e.g., checking drug-drug interactions, dosing, and side effects. In total, 15 MMP tasks were surveyed using a 5-point Likert scale ranging from "I complete this task alone" to "GP/CP completes this task alone". The study was conducted between 11/2020 and 04/2021. Data was analyzed using descriptive statistics. RESULTS: In total, 114/165 (69.1%) GPs and 166/243 (68.3%) CPs returned a questionnaire. The majority of GPs and CPs reported (i) checking clinical parameters and medication overuse and underuse to be completed by GPs, (ii) checking storage conditions of drugs and initial compilation of the patient's medication including brown bag review being mostly performed by CPs, and (iii) checking side-effects, non-adherence, and continuous updating of the medication list were carried out jointly. The responses differed most for problems with self-medication and adding and removing over-the-counter medicines from the medication list. In addition, the responses revealed that some MMP tasks were not sufficiently performed by either GPs or CPs. CONCLUSIONS: Both GPs' and CPs' expertise are needed to perform MMP as comprehensively as possible. Future studies should explore how GPs and CPs can complement each other in MMP most efficiently.

Shortcomings of Administrative Data to Derive Preventive Strategies for Inhospital Drug-Induced Acute Kidney Failure-Insights from Patient Record Analysis.

Structured analyses of hospital administrative data may detect potentially preventable adverse drug events (ADE) and therefore are considered promising sources to prevent future harm and estimate cost savings. Whether results of these analyses indeed correspond to ADE that may be preventable in clinical routines needs to be verified. We exemplarily screened all adult inpatients admitted to a German University Hospital (n = 54,032) for International Classification of Diseases-10th revision (ICD-10) diagnoses coding for drug-induced kidney injury (AKI). In a retrospective chart review, we checked the coded adverse events (AE) for inhospital occurrence, causality to drug exposure, and preventability in all identified cases and calculated positive predictive values (ppv). We identified 69 inpatient cases of whom 41 cases (59.4%) experienced the AE in the hospital (ppv-range 0.43-0.80). Causality assessment revealed a rather likely causal relationship between AE and drug exposure in 11 cases (15.9, 11/69, ppv-range 0.17-0.22) whereby preventability measures could be postulated for seven cases (10.1%, 7/69). Focusing on drug-induced AKI, this study exemplarily underlines that ICD-10-code-based ADE prevention efforts are quite limited due to the small identification rate and its high proportion of primarily outpatient events. Furthermore, causality assessment revealed that cases are often too complex to benefit from generic prevention strategies. Thus, ICD-10-code-based calculations might overestimate patient harm and economic losses.

HIOPP-6 - a pilot study on the evaluation of an electronic tool to assess and reduce the complexity of drug treatment considering patients' views.

BACKGROUND: A complex drug treatment might pose a barrier to safe and reliable drug administration for patients. Therefore, a novel tool automatically analyzes structured medication data for factors possibly contributing to complexity and subsequently personalizes the results by evaluating the relevance of each identified factor for the patient by means of key questions. Hence, tailor-made optimization measures can be proposed. METHODS: In this controlled, prospective, exploratory trial the tool was evaluated with nine general practitioners (GP) in three study groups: In the two intervention groups the tool was applied in a version with (GI_with) and a version without (GI_without) integrated key questions for the personalization of the analysis, while the control group (GC) did not use any tools (routine care). Four to eight weeks after application of the tool, the benefits of the optimization measures to reduce or mitigate complexity of drug treatment were evaluated from the patient perspective. RESULTS: A total of 126 patients regularly using more than five drugs could be included for analysis. GP suggested 117 optimization measures in GI_with, 83 in GI_without, and 2 in GC. Patients in GI_with were more likely to rate an optimization measure as helpful than patients in GI_without (IRR: 3.5; 95% CI: 1.2-10.3). Thereby, the number of optimization measures recommended by the GP had no significant influence (P = 0.167). CONCLUSIONS: The study suggests that an automated analysis considering patient perspectives results in more helpful optimization measures than an automated analysis alone - a result which should be further assessed in confirmatory studies. TRIAL REGISTRATION: The trial was registered retrospectively at the German Clinical Trials register under DRKS-ID DRKS00025257 (17/05/2021).

Prevalence and patient-rated relevance of complexity factors in medication regimens of community-dwelling patients with polypharmacy.

PURPOSE: To describe the prevalence of complexity factors in the medication regimens of community-dwelling patients with more than five drugs and to evaluate the relevance of these factors for individual patients. METHODS: Data were derived from the HIOPP-6 trial, a controlled study conducted in 9 general practices which evaluated an electronic tool to detect and reduce complexity of drug treatment. The prevalence of complexity factors was based on the results of the automated analysis of 139 patients' medication data. The relevance assessment was based on the patients' rating of each factor in an interview (48 patients included for analysis). RESULTS: A median of 5 (range 0-21) complexity factors per medication regimen were detected and at least one factor was observed in 131 of 139 patients. Almost half of these patients found no complexity factor in their medication regimen relevant. CONCLUSION: In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves. When assessing complexity of medication regimens, one should especially consider factors that are both particularly frequent and often challenging for patients, such as use of inhalers or tablet splitting. TRIAL REGISTRATION: The HIOPP-6 trial was registered retrospectively on May 17, 2021, in the German Clinical Trials register under DRKS-ID DRKS00025257.