[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.

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

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. 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.

Effectiveness, barriers and facilitating factors of strategies for active delabelling of patients with penicillin allergy labels: a systematic review protocol.

INTRODUCTION: Up to 15% of adult patients in the clinical setting report to be allergic to penicillin. However, in most cases, penicillin allergy is not confirmed. Due to the negative aspects associated with erroneous penicillin allergy, the implementation of active delabelling processes for penicillin allergy is an important part of antibiotic stewardship programmes. Depending on the clinical setting, different factors need to be considered during implementation. This review examines the effectiveness of different delabelling interventions and summarises components and structures that facilitate, support or constrain structured penicillin allergy delabelling. METHODS AND ANALYSIS: This review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The databases MEDLINE (via PubMed), EMBASE and Cochrane Library were searched for studies reporting on any intervention to identify, assess or rule out uncertain penicillin allergy. To improve completeness, two further databases are also searched for grey literature. Study design, intervention type, professional groups involved, effectiveness, limitations, barriers, facilitating factors, clinical setting and associated regulatory factors will be extracted and analysed. In addition, exclusion criteria for participation in the delabelling intervention and criteria for not delabelling penicillin allergy will be summarised. In case of failed protocols, these are highlighted and quantitatively analysed if possible. Two independent reviewers will perform the screening process and data extraction. Discordant decisions will be resolved through review by a third reviewer. Bias assessment of the individual studies will be performed using the Newcastle Ottawa Scale. ETHICS AND DISSEMINATION: Because individual patient-related data are not analysed, an ethical approval is not required. The review will be published in a peer-reviewed scientific journal.

Performance and risks of ChatGPT used in drug information: an exploratory real-world analysis.

OBJECTIVES: To investigate the performance and risk associated with the usage of Chat Generative Pre-trained Transformer (ChatGPT) to answer drug-related questions. METHODS: A sample of 50 drug-related questions were consecutively collected and entered in the artificial intelligence software application ChatGPT. Answers were documented and rated in a standardised consensus process by six senior hospital pharmacists in the domains content (correct, incomplete, false), patient management (possible, insufficient, not possible) and risk (no risk, low risk, high risk). As reference, answers were researched in adherence to the German guideline of drug information and stratified in four categories according to the sources used. In addition, the reproducibility of ChatGPT's answers was analysed by entering three questions at different timepoints repeatedly (day 1, day 2, week 2, week 3). RESULTS: Overall, only 13 of 50 answers provided correct content and had enough information to initiate management with no risk of patient harm. The majority of answers were either false (38%, n=19) or had partly correct content (36%, n=18) and no references were provided. A high risk of patient harm was likely in 26% (n=13) of the cases and risk was judged low for 28% (n=14) of the cases. In all high-risk cases, actions could have been initiated based on the provided information. The answers of ChatGPT varied over time when entered repeatedly and only three out of 12 answers were identical, showing no reproducibility to low reproducibility. CONCLUSION: In a real-world sample of 50 drug-related questions, ChatGPT answered the majority of questions wrong or partly wrong. The use of artificial intelligence applications in drug information is not possible as long as barriers like wrong content, missing references and reproducibility remain.

[Central anticholinergic, neuroleptic malignant and serotonin syndromes]. / Zentrales anticholinerges, malignes neuroleptisches und Serotoninsyndrom: Wichtige Differenzialdiagnosen bei postoperativen Bewusstseinsstörungen.

Impaired consciousness is a frequent phenomenon after general anesthesia. In addition to the classical causes (e.g., overhang of sedatives), an impairment of consciousness can also be an adverse side effect of drugs. Many drugs used in anesthesia can trigger these symptoms. Alkaloids, such as atropine can trigger a central anticholinergic syndrome, opioids can promote the occurrence of serotonin syndrome and the administration of a neuroleptic can lead to neuroleptic malignant syndrome. These three syndromes are difficult to diagnose due to the individually very heterogeneous symptoms. Mutual symptoms, such as impaired consciousness, tachycardia, hypertension and fever further complicate the differentiation between the syndromes; however, more individual symptoms, such as sweating, muscle tension or bowl sounds can be helpful in distinguishing these syndromes. The time from the trigger event can also help to differentiate the syndromes. The central anticholinergic syndrome is the fastest to appear, usually taking just a few of hours from trigger to clinical signs, serotonin syndrome takes several hours up to 1 day to show and neuroleptic malignant syndrome usually takes days. The clinical symptoms can range from mild to life-threatening. Generally, mild cases are treated with discontinuation of the trigger and extended observation. More severe cases can require specific antidotes. The specific treatment recommended for central anticholinergic syndrome is physostigmine with an initial dose of 2 mg (0.04 mg/kg body weight, BW) administered over 5 min. For serotonin syndrome an initial dose of 12 mg cyproheptadine followed by 2 mg every 2 h is recommended (maximum 32 mg/day or 0.5 mg/kgBW day-1) but this medication is only available in Germany as an oral formulation. For neuroleptic malignant syndrome 25-120 mg dantrolene (1-2.5 mg/kgBW maximum 10 mg/kgBW day-1) is the recommended treatment.

[Central anticholinergic, neuroleptic malignant and serotonin syndromes : Important differential diagnoses in postoperative impairment of consciousness]. / Zentrales anticholinerges, malignes neuroleptisches und Serotoninsyndrom : Wichtige Differenzialdiagnosen bei postoperativen Bewusstseinsstörungen.

Impaired consciousness is a frequent phenomenon after general anesthesia. In addition to the classical causes (e.g., overhang of sedatives), an impairment of consciousness can also be an adverse side effect of drugs. Many drugs used in anesthesia can trigger these symptoms. Alkaloids, such as atropine can trigger a central anticholinergic syndrome, opioids can promote the occurrence of serotonin syndrome and the administration of a neuroleptic can lead to neuroleptic malignant syndrome. These three syndromes are difficult to diagnose due to the individually very heterogeneous symptoms. Mutual symptoms, such as impaired consciousness, tachycardia, hypertension and fever further complicate the differentiation between the syndromes; however, more individual symptoms, such as sweating, muscle tension or bowl sounds can be helpful in distinguishing these syndromes. The time from the trigger event can also help to differentiate the syndromes. The central anticholinergic syndrome is the fastest to appear, usually taking just a few of hours from trigger to clinical signs, serotonin syndrome takes several hours up to 1 day to show and neuroleptic malignant syndrome usually takes days. The clinical symptoms can range from mild to life-threatening. Generally, mild cases are treated with discontinuation of the trigger and extended observation. More severe cases can require specific antidotes. The specific treatment recommended for central anticholinergic syndrome is physostigmine with an initial dose of 2 mg (0.04 mg/kg body weight, BW) administered over 5 min. For serotonin syndrome an initial dose of 12 mg cyproheptadine followed by 2 mg every 2 h is recommended (maximum 32 mg/day or 0.5 mg/kgBW day-1) but this medication is only available in Germany as an oral formulation. For neuroleptic malignant syndrome 25-120 mg dantrolene (1-2.5 mg/kgBW maximum 10 mg/kgBW day-1) is the recommended treatment.

Analysing and improving preoperative medication management in cardiac surgery.

AIMS: The objective of this study was to analyse the preoperative medication management within the cardiac surgery patient population and measure the effectiveness of an interprofessional intervention in routine care. METHODS: A jointly developed preoperative medication management was implemented in routine care on multiple levels (inclusion in admission letter to primary care, hotline for inquiries, pocket cards for physicians and correspondence with referring centres). The effectiveness was evaluated by analysing preoperative management before and after implementation. The primary endpoint was the number of drugs managed correctly according to the guidelines after implementation. Secondary endpoints consisted amongst others of bleeding on the intensive care unit, re-thoracotomy, postoperative infarction and cerebrovascular complications. Additionally, possible associations between the correct management and different variables were investigated by multivariate analysis. RESULTS: After the implementation, the number of drugs managed correctly according to guidelines increased from 54.0 to 73.5% (P < .001). The effect was more prominent for direct oral anticoagulants and prophylactic aspirin where the guideline adherence increased from 29.2 to 74.5% and from 78.6 to 95.1%, respectively. No difference was seen for sodium-glucose transporter-2 inhibitors, metformin, vitamin-K antagonists and dual-antiplatelet therapy. Secondary endpoints showed no safety signals with regard to bleeding or thrombotic events. In multivariate analysis, the intervention was effective (odds ratio 2.17, 95% confidence interval [1.32-3.62]) after adjusting for possible confounders. CONCLUSION: An interprofessional programme was effective to improve preoperative medication management in cardiac surgery patients. Sodium-glucose transporter-2 inhibitors, metformin and direct oral anticoagulants appear to be especially at risk for incorrect management before cardiac surgery with possible adverse events.

[Principles of the perioperative management of direct oral anticoagulants]. / Grundlagen des perioperativen Umgangs mit direkten oralen Antikoagulanzien.

Within the approved indications direct oral anticoagulants (DOAC) are increasingly gaining acceptance instead of vitamin K antagonists (VKA). In the last 12 months 5 guidelines relevant to the perioperative management of DOACs have been updated. This article summarizes the current recommendations for the perioperative management of treatment with DOACs. The available substances and their pharmacological properties as well as the possibilities for specific laboratory diagnostics of the effect of DOAC are explained. Special focus is placed on anesthesiologically important aspects of substance-specific preoperative and postoperative intermission intervals, the procedure for neuraxial regional anesthesia and antagonization with specific antidotes in cases of life-threatening bleeding.

Validation and Application of an HPLC-UV Method for Routine Therapeutic Drug Monitoring of Dalbavancin.

Dalbavancin is emerging as a promising alternative in the ambulant treatment of gram-positive infections that require long-term antibiotic treatment such as osteomyelitis, prosthetic joint infections, and endocarditis. The aim of the current study was to develop and validate a simple, rapid, and cost-effective high-performance liquid chromatography-ultraviolet spectrometry (HPLC-UV) method for the quantification of dalbavancin. Sample clean-up included a protein precipitation protocol, followed by chromatographic separation on a reverse phase HPLC column (C-18) with gradient elution of the mobile phase. Quantification was performed with the internal standard (caffeine) method. Linear relationships between peak area responses and drug concentrations were obtained in the range of 12.5-400 mg/L. The variation coefficient of precision and the bias of accuracy (both inter- and intraday) were less than 10%. The limit of quantification (LOQ) was 12.5 mg/L. The simple and reliable HPLC-UV assay described is a powerful tool for routine therapeutic drug monitoring (TDM) of dalbavancin in human serum in clinical laboratories. With a total process time of approximately 20 min, it allows for accurate and selective quantification up to the expected pharmacokinetic peak concentrations. The method was successfully used to analyze subsequent serum samples of three patients and showed good performance in monitoring serum levels.

Comparative Genomic Reveals Clonal Heterogeneity in Persistent Staphylococcus aureus Infection.

Persistent infections caused by Staphylococcus aureus remain a clinical challenge. Adaptational mechanisms of the pathogen influencing infection persistence, treatment success, and clinical outcome in these types of infections by S. aureus have not been fully elucidated so far. We applied a whole-genome sequencing approach on fifteen isolates retrieved from a persistent S. aureus infection to determine their genetic relatedness, virulome, and resistome. The analysis of the genomic data indicates that all isolates shared a common clonal origin but displayed a heterogenous composition of virulence factors and antimicrobial resistance. This heterogeneity was reflected by different mutations in the rpoB gene that were related to the phenotypic antimicrobial resistance towards rifampicin and different minimal inhibitory concentrations of oxacillin. In addition, one group of isolates had acquired the genes encoding for staphylokinase (sak) and staphylococcal complement inhibitor (scn), leading to the truncation of the hemolysin b (hlb) gene. These features are characteristic for temperate phages of S. aureus that carry genes of the immune evasion cluster and confer triple conversion by integration into the hlb gene. Modulation of immune evasion mechanisms was demonstrated by significant differences in biofilm formation capacity, while invasion and intracellular survival in neutrophils were not uniformly altered by the presence of the immune evasion cluster. Virulence factors carried by temperate phages of S. aureus may contribute to the course of infection at different stages and affect immune evasion and pathogen persistence. In conclusion, the application of comparative genomic demonstrated clonal heterogeneity in persistent S. aureus infection.

Changing the medication documentation process for discharge: impact on clinical routine and documentation quality-a process analysis.

OBJECTIVES: In 2017, an in-house best-practice process for medication documentation was developed and implemented to meet the new German legal requirements concerning the management of patient discharge from the hospital. Because this law regulates the common steps of good discharge practices (eg, specification of discharge mediation documentation), we used its implementation to assess the impact of such a measure on the quality of medication documentation and related workflows in clinical routine. METHODS: By observing workflows and interviewing the affected employees, we analysed the medication workflow processes from admission to discharge of seven representative departments of a large university hospital before and early after implementation of a newly defined best-practice process. To investigate the implementation impact, following measures were determined overall and for five key process steps: quality of medication documentation as measured by predefined criteria, the adherence to the best-practice process (range 0%-100%), workload and potential shifts in responsibilities. RESULTS: Already early after implementation, all departments met the legal requirements and the quality of the medication documentation increased from low to high quality in most departments. Mean adherence to the best-practice process was 77% (range 60%-100%) with strictest adherence of 100% in one department. Thereby, the number of process steps and hence, likely also the workload increased in all departments. New tasks were mainly performed by physicians and in one department by pharmacists. CONCLUSIONS: The new lawful best-practice process led to a higher quality in medication documentation at the cost of a higher workload for physicians, potentially limiting time for other care tasks. Therefore, it could be important to define areas of the medication documentation process in which physicians could be supported by other professions or new tools facilitating accurate medication documentation as the basis of continuity of care.

Renal Safety of Hydroxyethyl starch 130/0.42 After Cardiac Surgery: A Retrospective Cohort Analysis.

INTRODUCTION: The risk for renal complications from hydroxyethyl starch 130/0.42 (HES) impacts treatment decisions in patients after cardiac surgery. OBJECTIVE: The objective of this study was to determine the impact of postoperatively administered HES on renal function and 90-day mortality compared to sole crystalloid administration in patients after elective cardiac surgery. METHODS: Using electronic health records from a university hospital, confounding-adjusted models analyzed the associations between postoperative HES administration and the occurrence of postoperative acute kidney injury. In addition, 90-day mortality was evaluated. The impact of HES dosage and timing on renal function on trajectories of estimated glomerular filtration rates over the postoperative period was investigated using linear mixed-effects models. RESULTS: Overall 1009 patients (45.0%) experienced acute kidney injury. Less acute kidney injury occurred in patients receiving HES compared with patients receiving only crystalloids for fluid resuscitation (43.7% vs 51.2%, p = 0.008). In multivariate acute kidney injury models, HES had a protective association (odds ratio: 0.89; 95% confidence interval 0.82-0.96). Crystalloids were not as protective as HES (odds ratio: 0.98; 95% confidence interval 0.95-1.00). There was no association between HES and 90-day mortality (odds ratio: 1.05; 95% confidence interval 0.88-1.25). Renal function trajectories were dose dependent and biphasic, HES appeared to slow down the late postoperative decline. CONCLUSIONS: This study showed no association between HES and the postoperative occurrence of acute kidney injury and thus further closes the evidence gap on HES safety in cardiac surgery patients. Although this was a retrospective cohort study, the results indicated that HES might be safely administered to cardiac surgery patients with regard to renal outcomes, especially if it was administered early and dosed appropriately.

Structure and Content of Drug Monitoring Advices Included in Discharge Letters at Interfaces of Care: Exploratory Analysis Preceding Database Development.

BACKGROUND: Inadequate drug monitoring of drug therapy after hospital discharge facilitates adverse drug events and preventable hospital readmissions. OBJECTIVE: This study aimed to analyze the structure and content of drug monitoring advices of a representative sample of discharge letters as a basis for future electronic information systems. METHODS: On 2 days in November 2016, all discharge letters of 3 departments of a university hospital were extracted from the hospital information system. The frequency, content, and structure of drug monitoring advices in discharge letters were investigated and compared with the theoretical monitoring requirements expressed in the corresponding summaries of product characteristics (SmPC). The quality of the drug monitoring advices in the discharge letters was rated with the domains of an adapted systematic instructions for monitoring (SIM) score. RESULTS: In total, 154 discharge letters were analyzed containing 1180 brands (240 active pharmaceutical substances), of which 50.42% (595/1180) could theoretically be amended with a monitoring advice according to the SmPC. In reality, 40 discharge letters (26.0%, 40/154) contained a total of 66 monitoring advices for 57 brands (4.83%, 57/1180), comprising 18 different monitoring parameters. Drug monitoring advices only addressed mean 1.9 (SD 0.8) of the 7 domains of the SIM score and frequently did not address reasons for monitoring (86%, 57/66), the timing of monitoring, that is, the start (76%, 50/66), the frequency (94%, 63/66), the stop (95%, 63/66), and how to react (83%, 55/66). CONCLUSIONS: Drug monitoring advices were mostly absent in discharge letters and a gold standard for appropriate drug monitoring advices was lacking. Hence, more effort should be put in the development of tools that facilitate easy presentation of clinically meaningful drug monitoring advices at the point of care.

[Medication safety in hospitals : Integration of clinical pharmacists to reduce drug-related problems in the inpatient setting]. / Arzneimitteltherapiesicherheit im Krankenhaus : Einbindung von Stationsapothekern zur Reduktion von arzneimittelbezogenen Problemen im stationären Medikationsprozess.

Drug-related problems (DRPs) are a significant and often preventable cause for morbidity and mortality. Hospitalization is associated with a high risk for DRPs, especially due to a lack of information transfer at transitions of care. At the same time, interventions during inpatient treatment usually require a change in drug therapy and additionally increase the risk of DRPs. Thereby, DRPs can occur at all levels of the medication process and can be caused by different groups of professionals. One way to improve medication safety in hospitals is to integrate clinical pharmacists into the medication process.According to available data, the integration of a clinical pharmacist in multi-professional teams during admission, hospitalization and discharge can significantly reduce DRPs, costs and increases efficacy of drug therapy. In addition, drug supply with unit-dose systems in combination with digitalization of the medication process can achieve an improvement in medication safety. Improvement in continuity of medical care through a structured medication review and seamless transmission of medically relevant information upon discharge contribute to a significant reduction of hospital readmissions and emergency admissions due to ABPs, as well as health costs. With a university education, the hospital pharmacist specialized in clinical pharmacy is the only professional group that can comprehensively support the physician in the field of drug therapy.

Risk factors of adverse health outcomes after hospital discharge modifiable by clinical pharmacist interventions: a review with a systematic approach.

The present review assessed the evidence on risk factors for the occurrence of adverse health outcomes after discharge (i.e. unplanned readmission or adverse drug event after discharge) that are potentially modifiable by clinical pharmacist interventions. The findings were compared with patient characteristics reported in guidelines that supposedly indicate a high risk of drug-related problems. First, guidelines and risk assessment tools were searched for patient characteristics indicating a high risk of drug-related problems. Second, a systematic PubMed search was conducted to identify risk factors significantly associated with adverse health outcomes after discharge that are potentially modifiable by a clinical pharmacist intervention. After the PubMed search, 37 studies were included, reporting 16 risk factors. Only seven of 34 patient characteristics mentioned in pertinent guidelines corresponded to one of these risk factors. Diabetes mellitus (n = 11), chronic obstructive lung disease (n = 9), obesity (n = 7), smoking (n = 5) and polypharmacy (n = 5) were the risk factors reported most frequently in the studies. Additionally, single studies also found associations of adverse health outcomes with different drug classes {e.g. warfarin [hazard ratio 1.50; odds ratio (OR) 3.52], furosemide [OR 2.25] or high beta-blocker starting doses [OR 3.10]}. Although several modifiable risk factors were found, many patient characteristics supposedly indicating a high risk of drug-related problems were not part of the assessed risk factors in the context of an increased risk of adverse health outcomes after discharge. Therefore, an obligatory set of modifiable patient characteristics should be created and implemented in future studies investigating the risk for adverse health outcomes after discharge.