The effect of medication reconciliation via a patient portal on medication discrepancies: a randomized noninferiority study

Background: Medication reconciliation has become standard care to prevent medication transfer errors. However, this process is time-consuming but could be more efficient when patients are engaged in medication reconciliation via a patient portal. Objectives: To explore whether medication reconciliation by the patient via a patient portal is noninferior to medication reconciliation by a pharmacy technician. Design (including intervention): Open randomized controlled noninferiority trial. Patients were randomized between medication reconciliation via a patient portal (intervention) or medication reconciliation by a pharmacy technician at the preoperative screening (usual care). Setting and Participants: Patients scheduled for elective surgery using at least 1 chronic medication were included. Measures: The primary endpoint was the number of medication discrepancies compared to the electronic nationwide medication record system (NMRS). For the secondary endpoint, time investment of the pharmacy technician for the medication reconciliation interview and patient satisfaction were studied. Noninferiority was analyzed with an independent t test, and the margin was set at 20%. Results: A total of 499 patients were included. The patient portal group contained 241 patients; the usual care group contained 258 patients. The number of medication discrepancies was 2.6 +/- 2.5 in the patient portal group and 2.8 +/- 2.7 in the usual care group. This was not statistically different and within the predefined noninferiority margin. Patients were satisfied with the use of the patient portal tool. Also, the use of the portal can save on average 6.8 minutes per patient compared with usual care. Conclusions and Implications: Medication reconciliation using a patient portal is noninferior to medication reconciliation by a pharmacy technician with respect to medication discrepancies, and saves time in the medication reconciliation process. Future studies should focus on identifying patient characteristics for successful implementation of patient portal medication reconciliation. (c) 2021 The Authors. Published by Elsevier Inc. on behalf of AMDA -The Society for Post-Acute and Long-Term Care Medicine. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).Clinical Pharmacy and Toxicolog

Liver and kidney function in patients with Covid-19 treated with remdesivir

For the treatment of Covid-19 patients with remdesivir, poor renal and liver function were both exclusion criteria in randomized clinical trials and contraindication for treatment. Also, nephrotoxicity and hepatotoxicity are reported as adverse events. We retrospectively reviewed renal and liver functions of Covid-19 103 patients who received remdesivir in the 15 days after treatment initiation. Approximately 20% of the patient population met randomized clinical trial exclusion criteria. In total, 11% of the patients had a decrease in estimated glomerular filtration rate >10 mL/min/1.73m(2). Also, 25 and 35% had increased alanine transaminase and aspartate transaminase levels, respectively. However, serious adverse events were limited. Therefore, based on these preliminary results, contraindications based on kidney and liver function should not be absolute for remdesivir treatment in patients with Covid-19 if these functions are monitored regularly. A larger patient cohort is warranted to confirm our results.Immunogenetics and cellular immunology of bacterial infectious disease

Real-world metastatic renal cell carcinoma treatment patterns and clinical outcomes in the Netherlands

The number of treatment options for patients with metastatic renal cell carcinoma (mRCC) has significantly grown in the last 15 years. Although randomized controlled trials are fundamental in investigating mRCC treatment efficacy, their external validity can be limited. Therefore, the efficacy of the different treatment options should also be evaluated in clinical practice. We performed a chart review of electronic health records using text mining software to study the current treatment patterns and outcomes. mRCC patients from two large hospitals in the Netherlands, starting treatment between January 2015 and May 2020, were included. Data were collected from electronic health records using a validated text mining tool. Primary endpoints were progression-free survival (PFS) and overall survival (OS). Statistical analyses were performed using the Kaplan-Meier method. Most frequent first-line treatments were pazopanib (n = 70), sunitinib (n = 34), and nivolumab with ipilimumab (n = 28). The overall median PFS values for first-line treatment were 15.7 months (95% confidence interval [95%CI], 8.8-20.7), 16.3 months (95%CI, 9.3-not estimable [NE]) for pazopanib, and 6.9 months (95% CI, 4.4-NE) for sunitinib. The overall median OS values were 33.4 months (95%CI, 28.1-50.9 months), 39.3 months (95%CI, 29.5-NE) for pazopanib, and 28.1 months (95%CI, 7.0-NE) for sunitinib. For nivolumab with ipilimumab, median PFS and median OS were not reached. Of the patients who finished first- and second-line treatments, 64 and 62% received follow-up treatments, respectively. With most patients starting on pazopanib and sunitinib, these real-world treatment outcomes were most likely better than in pivotal trials, which may be due to extensive follow-up treatments.Clinical epidemiolog

Treatment failure in patients with epilepsy -Exploring causes of ineffectiveness and adverse effects

Epilepsy is a neurological disorder that leads to seizures affecting a variety of mental and physical functions. Antiepileptic drugs are the mainstay of treatment. However, in one third of patients treatment fails: patients keep getting seizures or experience bothersome side effects. In this thesis the two components of treatment failure in epilepsy are studied: 1. Ineffectiveness: the burden that seizures cannot be controlled with medication and 2. Adverse effects: the unwanted symptoms of antiepileptic drugs. We state that treatment response -independent of the disease or the syndrome- relies on three key actors: the patient, the drug, and the health care professional. In this thesis, the interaction and the different roles of these important modulators on treatment response in epilepsy was clarified. In the first part we illustrated that health care professional-related factors such as changes in medication regimes, and patient-related factors such as omitting medication can lead to insufficient seizure control. Also, we concluded that patients with low antiepileptic drugs serum levels have a nine times higher risk of seizures compared with patients with therapeutic antiepileptic drugs levels. Therapeutic drug monitoring is therefore a valuable tool that, once used appropriate, may prevent seizures. In the second part of this thesis gene-related causes of drug-resistant epilepsy were studied. This is an interesting phenomenon since if an association between certain genetic factors and refractory epilepsy could be confirmed, patients with epilepsy could be screened beforehand in order to optimize drug selection leading to improved seizure-control. To study pharmacogenetic associations almost 300 patients treated at one of the main tertiary epilepsy centres in the Netherlands were asked to participate. We extensively explored the association between all known variations (high resolution haplotypes) of the ABCB1 gene and drug-resistant epilepsy as well as a functional polymorphism in the SCN1A gene and drug-resistant epilepsy. No association was found for individual polymorphisms or haplotypes from ABCB1 or SCN1A and drug-resistant epilepsy. In the third part adverse effects of antiepileptic drugs are studied. For this thesis we made a selection of those that we thought were clinically relevant and often leading to therapeutic failure. Hypersensitivity reactions can be severe in patients using antiepileptic drugs; so far it was unclear why this occurs. We found that the presence of an aromatic ring as a commonality in chemical structures of antiepileptic drugs may explain hypersensitivity reactions. Aplastic anemia is a rare, but feared adverse effect of drug treatment often responsible for taking drugs from the market. We studied whether the use of antiepileptic drugs was associated with aplastic anemia. Our conclusion was that use of antiepileptic drugs is associated with a ninefold increased risk of aplastic anemia. Therefore, health care professionals should be alert to the possibility of AED-associated aplastic anemia. In conclusion, treatment failure in epilepsy has an enormous impact on daily life. In this thesis we studied causes of ineffectiveness and adverse events of AED treatment and provided suggestions for interventions in order to improve treatment response in patients with epilepsy

Improving patient access to hospital pharmacists using eConsults: retrospective descriptive study

Background: eConsults are increasingly used worldwide to reduce specialist referrals and increase access to medical care. An additional benefit of using an eConsult tool is a reduction of health care costs while improving the quality of health care and patient participation. Currently, shared decision making is increasingly implemented and preferred by patients. eConsults are also a promising tool to improve access to the hospital pharmacist. Patients often have questions about their medication. When medication is started during a hospital admission or outpatient visit, community pharmacists are not always sufficiently informed to answer patient questions. Direct contact with hospital pharmacists may be more appropriate and efficient. This contact is facilitated through the eConsult feature in the hospital's patient portal. Objective: This study aims to evaluate the prevalence and contents of the eConsults sent by patients to hospital pharmacists.Methods: A first retrospective descriptive study was conducted at the Leiden University Medical Center in the Netherlands. Patients who sent at least one eConsult to a hospital pharmacist between March 2017 and December 2021 were included. Patient characteristics and the number of medications taken were extracted from electronic health records. The content of eConsults was analyzed and grouped into different subjects. Time of sending of the eConsults was analyzed. A comparison was made between the number of eConsults sent to the hospital pharmacy and the number sent to the medical center. Finally, the appropriateness for evaluation by the hospital pharmacist was assessed in all eConsults.Results: During the study period, 983 eConsults (from 808 patients) were sent to the hospital pharmacist. The average patient age was 56 (SD 15.9) years, and 51.4% (415/808) were male; 47.8% (386/808) of the patients used 0 to 4 medications, 33.0% (267/808) used 5 to 9 medications, and 19.2% (155/808) used =10 medications. Of the eConsults, 10.9% (107/983) were excluded due to not being medication-related or not intended for the hospital pharmacist. Patients being treated in 31 medical specialties sent eConsults to the hospital pharmacist. The most common medical specialty was cardiology with 22.5% (197/876) of the eConsults. Most eConsults were sent during office hours (614/876, 70.2%). eConsult subjects were medication verification (372/876, 42.5%), logistics (243/876, 27.7%), therapeutic effect and adverse events (100/876, 11.4%), use of medication (87/876,Conclusions: Introducing eConsults allows patients to ask medication-related questions directly to hospital pharmacists. Our study shows that patients send medication reconciliation-related eConsults most often. Use of the eConsult tool leads to fast, direct, and documented communication between patient and hospital pharmacist. This can reduce medication-related errors, improve patient empowerment, and increase access to the hospital pharmacist.Clinical Pharmacy and Toxicolog

An electronic health record text mining tool to collect real-world drug treatment outcomes: a validation study in patients with metastatic renal cell carcinoma

Real-world evidence can close the inferential gap between marketing authorization studies and clinical practice. However, the current standard for real-world data extraction from electronic health records (EHRs) for treatment evaluation is manual review (MR), which is time-consuming and laborious. Clinical Data Collector (CDC) is a novel natural language processing and text mining software tool for both structured and unstructured EHR data and only shows relevant EHR sections improving efficiency. We investigated CDC as a real-world data (RWD) collection method, through application of CDC queries for patient inclusion and information extraction on a cohort of patients with metastatic renal cell carcinoma (RCC) receiving systemic drug treatment. Baseline patient characteristics, disease characteristics, and treatment outcomes were extracted and these were compared with MR for validation. One hundred patients receiving 175 treatments were included using CDC, which corresponded to 99% with MR. Calculated median overall survival was 21.7 months (95% confidence interval (CI) 18.7-24.8) vs. 21.7 months (95% CI 18.6-24.8) and progression-free survival 8.9 months (95% CI 5.4-12.4) vs. 7.6 months (95% CI 5.7-9.4) for CDC vs. MR, respectively. Highest F1-score was found for cancer-related variables (88.1-100), followed by comorbidities (71.5-90.4) and adverse drug events (53.3-74.5), with most diverse scores on international metastatic RCC database criteria (51.4-100). Mean data collection time was 12 minutes (CDC) vs. 86 minutes (MR). In conclusion, CDC is a promising tool for retrieving RWD from EHRs because the correct patient population can be identified as well as relevant outcome data, such as overall survival and progression-free survival

Application of Electronic Health Record Text Mining: real-world tolerability, safety, and efficacy of adjuvant melanoma treatments

Simple Summary: Recently, nivolumab, pembrolizumab, both immune-checkpoint inhibitors (ICIs) and the combination of dabrafenib plus trametinib (D + T) were registered as adjuvant melanoma treatments, to prevent recurrence. The aim of this paper was to retrospectively review the benefits and risks of these treatments in clinical practice, by extracting data from electronic health records with a text-mining tool. In a population of 122 patients, 55 used nivolumab, 48 used pembrolizumab and 20 used D + T, and we found that the ICIs were better tolerated than D + T. However, the frequent adverse events of D + T are reversible and include pyrexia and fatigue. ICIs show immune-related chronic adverse events, and chronic thyroid-related adverse events occurred frequently. The efficacy results, including the recurrence-free survival, are promising; however, the follow-up was too short for conclusions. This study furthermore showed that the application of text-mining is a valuable method to collect data for the evaluation of adjuvant melanoma treatments.Abstract - Introduction:  Nivolumab (N), pembrolizumab (P), and dabrafenib plus trametinib (D + T) have been registered as adjuvant treatments for resected stage III and IV melanoma since 2018. Electronic health records (EHRs) are a real-world data source that can be used to review treatments in clinical practice. In this study, we applied EHR text-mining software to evaluate the real-world tolerability, safety, and efficacy of adjuvant melanoma treatments. Methods: Adult melanoma patients receiving adjuvant treatment between January 2019 and October 2021 at the Leiden University Medical Center, the Netherlands, were included. CTcue text-mining software (v3.1.0, CTcue B.V., Amsterdam, The Netherlands) was used to construct rule-based queries and perform context analysis for patient inclusion and data collection from structured and unstructured EHR data. Results: In total, 122 patients were included: 54 patients treated with nivolumab, 48 with pembrolizumab, and 20 with D + T. Significantly more patients discontinued treatment due to toxicity on D + T (N: 16%, P: 6%, D + T: 40%), and X-2 (6, n = 122) = 14.6 and p = 0.024. Immune checkpoint inhibitors (ICIs) mainly showed immune-related treatment-limiting adverse events (AEs), and chronic thyroid-related AE occurred frequently (hyperthyroidism: N: 15%, P: 13%, hypothyroidism: N: 20%, P: 19%). Treatment-limiting toxicity from D + T was primarily a combination of reversible AEs, including pyrexia and fatigue. The 1-year recurrence-free survival was 70.3% after nivolumab, 72.4% after pembrolizumab, and 83.0% after D + T. Conclusions: Text-mining EHR is a valuable method to collect real-world data to evaluate adjuvant melanoma treatments. ICIs were better tolerated than D + T, in line with RCT results. For BRAF+ patients, physicians must weigh the higher risk of reversible treatment-limiting AEs of D + T against the risk of long-term immune-related AEs.</p

Application of Electronic Health Record Text Mining: Real-World Tolerability, Safety, and Efficacy of Adjuvant Melanoma Treatments

Simple Summary Recently, nivolumab, pembrolizumab, both immune-checkpoint inhibitors (ICIs) and the combination of dabrafenib plus trametinib (D + T) were registered as adjuvant melanoma treatments, to prevent recurrence. The aim of this paper was to retrospectively review the benefits and risks of these treatments in clinical practice, by extracting data from electronic health records with a text-mining tool. In a population of 122 patients, 55 used nivolumab, 48 used pembrolizumab and 20 used D + T, and we found that the ICIs were better tolerated than D + T. However, the frequent adverse events of D + T are reversible and include pyrexia and fatigue. ICIs show immune-related chronic adverse events, and chronic thyroid-related adverse events occurred frequently. The efficacy results, including the recurrence-free survival, are promising; however, the follow-up was too short for conclusions. This study furthermore showed that the application of text-mining is a valuable method to collect data for the evaluation of adjuvant melanoma treatments. Introduction: Nivolumab (N), pembrolizumab (P), and dabrafenib plus trametinib (D + T) have been registered as adjuvant treatments for resected stage III and IV melanoma since 2018. Electronic health records (EHRs) are a real-world data source that can be used to review treatments in clinical practice. In this study, we applied EHR text-mining software to evaluate the real-world tolerability, safety, and efficacy of adjuvant melanoma treatments. Methods: Adult melanoma patients receiving adjuvant treatment between January 2019 and October 2021 at the Leiden University Medical Center, the Netherlands, were included. CTcue text-mining software (v3.1.0, CTcue B.V., Amsterdam, The Netherlands) was used to construct rule-based queries and perform context analysis for patient inclusion and data collection from structured and unstructured EHR data. Results: In total, 122 patients were included: 54 patients treated with nivolumab, 48 with pembrolizumab, and 20 with D + T. Significantly more patients discontinued treatment due to toxicity on D + T (N: 16%, P: 6%, D + T: 40%), and X-2 (6, n = 122) = 14.6 and p = 0.024. Immune checkpoint inhibitors (ICIs) mainly showed immune-related treatment-limiting adverse events (AEs), and chronic thyroid-related AE occurred frequently (hyperthyroidism: N: 15%, P: 13%, hypothyroidism: N: 20%, P: 19%). Treatment-limiting toxicity from D + T was primarily a combination of reversible AEs, including pyrexia and fatigue. The 1-year recurrence-free survival was 70.3% after nivolumab, 72.4% after pembrolizumab, and 83.0% after D + T. Conclusions: Text-mining EHR is a valuable method to collect real-world data to evaluate adjuvant melanoma treatments. ICIs were better tolerated than D + T, in line with RCT results. For BRAF+ patients, physicians must weigh the higher risk of reversible treatment-limiting AEs of D + T against the risk of long-term immune-related AEs.Clinical Pharmacy and Toxicolog

Real-world evaluation of supportive care using an electronic health record text-mining tool: G-CSF use in breast cancer patients

Purpose Chemotherapy-induced febrile neutropenia (FN) is a life-threatening and chemotherapy dose-limiting adverse event. FN can be prevented with granulocyte-colony stimulating factors (G-CSFs). Guidelines recommend primary G-CSF use for patients receiving either high (> 20%) FN risk (HR) chemotherapy, or intermediate (10-20%) FN risk (IR) chemotherapy if the overall risk with additional patient-related risk factors exceeds 20%. In this study, we applied an EHR text-mining tool for real-world G-CSF treatment evaluation in breast cancer patients. Methods Breast cancer patients receiving IR or HR chemotherapy treatments between January 2015 and February 2021 at LUMC, the Netherlands, were included. We retrospectively collected data from EHR with a text-mining tool and assessed G-CSF use, risk factors, and the FN and neutropenia (grades 3-4) and incidence. Results A total of 190 female patients were included, who received 77 HR and 113 IR treatments. In 88.3% of the HR regimens, G-CSF was administered; 7.3% of these patients developed FN vs. 33.3% without G-CSF. Although most IR regimen patients had >= 2 risk factors, only 4% received G-CSF, of which none developed neutropenia. However, without G-CSF, 11.9% developed FN and 31.2% severe neutropenia. Conclusions Our text-mining study shows high G-CSF use among HR regimen patients, and low use among IR regimen patients, although most had >= 2 risk factors. Therefore, current practice is not completely in accordance with the guidelines. This shows the need for increased awareness and clarity regarding risk factors. Also, text-mining can effectively be implemented for the evaluation of patient care.Clinical Pharmacy and Toxicolog

Prospective Validation of a Risk Prediction Model to Identify High-Risk Patients for Medication Errors at Hospital Admission

Personalised Therapeutic