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Clinical Pharmacokinetics Jun 2024Levetiracetam is an antiseizure medication used for several seizure types in adults and children aged 1 month and older; however, due to a lack of data, pharmacokinetic...
Application of Physiologically Based Pharmacokinetic Modeling to Characterize the Effects of Age and Obesity on the Disposition of Levetiracetam in the Pediatric Population.
BACKGROUND
Levetiracetam is an antiseizure medication used for several seizure types in adults and children aged 1 month and older; however, due to a lack of data, pharmacokinetic (PK) variability of levetiracetam is not adequately characterized in certain populations, particularly neonates, children younger than 2 years of age, and children older than 2 years of age with obesity.
OBJECTIVE
This study aimed to address the gap by leveraging PK data from two prospective standard-of-care pediatric trials (n = 88) covering an age range from 1 month to 19 years, including those with obesity (64%), and applying a physiologically based PK (PBPK) modeling framework.
METHODS
A published PBPK model of levetiracetam for children aged 2 years and older was extended to pediatric patients younger than 2 years of age and patients older than 2 years of age with obesity by accounting for the obesity and age-related changes in PK using PK-Sim software. The prospective pediatric data, along with the literature data for neonates and children younger than 2 years of age, were used to evaluate the extended PBPK models.
RESULTS
Overall, 82.4% of data fell within the 90% interval of model-predicted concentrations, with an average fold error within twofold of the accepted criteria. PBPK modeling revealed that children with obesity had lower weight-normalized clearances (0.053 L/h/kg) on average than children without obesity (0.063 L/h/kg). The effect of maturation was well-characterized, resulting in comparable PBPK-simulated, weight-normalized clearances for neonates and children younger than 2 years of age reported from the literature.
CONCLUSIONS
PBPK modeling simulations revealed that the current US FDA-labeled pediatric dosing regimen listed in the prescribing information can produce the required exposure of levetiracetam in these target populations with dose adjustments for children with obesity aged 4 years to younger than 16 years.
Topics: Humans; Levetiracetam; Child, Preschool; Child; Models, Biological; Infant; Adolescent; Anticonvulsants; Male; Female; Age Factors; Infant, Newborn; Young Adult; Obesity; Prospective Studies; Computer Simulation
PubMed: 38814425
DOI: 10.1007/s40262-024-01367-2 -
European Journal of Hospital Pharmacy :... May 2024Patients in intensive care units (ICUs) are susceptible to medication errors (MEs) for many reasons, including the complexity and intensity of care. Little is known...
BACKGROUND
Patients in intensive care units (ICUs) are susceptible to medication errors (MEs) for many reasons, including the complexity and intensity of care. Little is known about patient safety culture, its relationship to medication safety, and ME prevention strategies used in ICUs. This study explored the attitudes of healthcare professionals (HCPs) working in ICUs or within medication safety towards patient safety culture, medication safety, and factors influencing implementation of ME prevention strategies in ICUs across Europe.
METHODS
This qualitative study employed focus group discussions; ethical approval was obtained. Invitations to participate were distributed to HCPs working in ICUs or as medication safety officers across Europe. In May 2022, online focus group discussions were conducted. Discussions were transcribed verbatim and analysed. The framework analysis employed was inductive, systematic and transparent, and completed through a collaborative and iterative process.
RESULTS
Three nurses and 11 pharmacists, from seven different countries, participated in three focus group discussions. There was a sense of improvement in blame culture leading to more open culture, although it was not the case for all participants. Blame culture, when present, was thought to be prevalent among more senior ICU staff and hospital managers. Facilitators for improving medication safety included communicating with HCPs and providing feedback on MEs and ME prevention strategies, interprofessional working without hierarchies, and having a 'good' culture and environment. Barriers included lack of engagement of HCPs and their attitudes towards medication safety, and an existing blame culture. Participants reported 25 different ME prevention strategies in use including: assessing knowledge; teaching and training; auditing practice; incident reporting; and involvement of pharmacists.
CONCLUSIONS
This study examined the attitudes of HCPs on patient safety culture and medication safety in the ICU setting in Europe and gained their insight into facilitators and barriers to the implementation of ME prevention strategies to improve medication safety.
PubMed: 38811151
DOI: 10.1136/ejhpharm-2024-004212 -
Biological Research For Nursing May 2024The aim of this study was to investigate the effects of an 8-week yoga intervention on muscle strength, proprioception, pain, concerns about falling, and quality of life...
OBJECTIVE
The aim of this study was to investigate the effects of an 8-week yoga intervention on muscle strength, proprioception, pain, concerns about falling, and quality of life in individuals diagnosed with diabetic neuropathy.
METHODS
A quasi-experimental design incorporating a pretest-posttest methodology and a control group was implemented in the present study. A total of 30 patients who were diagnosed with type 2 diabetes and neuropathy were recruited and randomly assigned to intervention ( = 15) or non-exercise control ( = 15). Yoga sessions were conducted for a duration of 60 min on three occasions per week, with participants requested to practice at home on other days.
RESULTS
The results showed significant main effects of time on the muscle strength (both flexor and extensor muscles, < .001, ηp = 0.652 and < .001, ηp = 0.539, respectively), proprioception error ( < .001, ηp = 0.807), pain intensity ( < .001, ηp = 0.538), concerns about falling ( < .001, ηp = 0.700), and overall score of quality of life ( < .001, ηp = 0.475). Moreover, there were significant group-by-time interactions for all variables ( < .001 for all).
CONCLUSION
The study reveals that yoga intervention can be an effective alternative therapeutic approach to medication for individuals with diabetic neuropathy. Yet, future studies are needed on a larger sample size to strengthen the present understanding of the advantageous impact of yoga intervention in this population.
PubMed: 38810022
DOI: 10.1177/10998004241256097 -
Rhode Island Medical Journal (2013) Jun 2024Remote self-measured blood pressure (SMBP) programs improve racial health equity among postpartum people with hypertensive disorders of pregnancy (HDP) who receive... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Remote self-measured blood pressure (SMBP) programs improve racial health equity among postpartum people with hypertensive disorders of pregnancy (HDP) who receive recommended blood pressure ascertainment after hospital discharge.1-3 However, as prior studies have been conducted within racially diverse but ethnically homogeneous populations,1-3 the effect of SMBP programs on ethnicity-based inequities is less understood.4 We examined whether SMBP rates differed among Hispanic versus non-Hispanic participants in remote SMBP programs.
STUDY DESIGN
This is a planned secondary analysis of a RCT conducted among postpartum patients with HDP who were enrolled into our remote SMBP program, in which they obtain SMBP and then manually enter the SMBP value into a patient portal for individual provider response. In the parent trial, consenting patients were randomized to continued manual blood pressure entry of SMBP or use of a Bluetooth-enabled blood pressure cuff synched to a smartphone application utilizing artificial intelligence to respond to each obtained blood pressure or symptom for six weeks and to flag abnormalities for providers. Both SMBP programs were available in Spanish and English. For this study, women who self-reported their ethnicity were stratified into two ethnic groups - Hispanic and non-Hispanic - regardless of randomization group. Those who did not self-report ethnicity but completed all study procedures in Spanish were also categorized as Hispanic. Outcomes were the same in the parent study and this secondary analysis. The primary outcome was ≥1 SMBP assessment within 10 days postpartum. Secondary outcomes included number of blood pressure assessments and healthcare utilization outcomes (remote antihypertensive medication initiation or dose-increase and presentation to the Emergency Department or readmission for hypertension within 30 days of discharge). Participants rated their experience with SMBP via a scale from 0 (worst possible) to 10 (best possible) and the Decision Regret Scale, which assessed their regret in SMBP program participation (0=no regret; 100=high regret)).5 Outcomes were compared between groups. Risk differences (RD) were calculated for categorical and regression coefficients for continuous outcomes. The parent RCT was IRB-approved and published on clinicaltrials.gov (NCT05595629) before enrollment.
RESULTS
Among 119 women in the parent study, 83 (70%) self-reported ethnicity and the proportion of Hispanic people was similar in both treatment groups. This study compared 23 Hispanic (19% monolingual in Spanish) to 62 non-Hispanic women. Rates of SMBP assessment within 10 days postpartum was similar (Hispanic 64% vs non-Hispanic 79%; RD -0.1 (95% Confidence Interval (CI) -0.4, 0.1). There were no differences in mean number of remote SMBP assessments or rates of remote antihypertensive medication initiation or dose titration. The rates of hypertension-related presentations to the Emergency Department or hospital readmission were also similar between groups. Lastly, regardless of ethnicity, participants had low scores on the Decision Regret Scale and rated their experience with their remote SMBP program highly favorably. (See Table 1.) Conclusion: Hispanic and non-Hispanic postpartum patients with HDP had similar outcomes and favorable patient perceptions. The small sample size in this study may have produced inadequate power to detect a difference between study groups, thereby leading to Type II error. Thus, more research on Hispanic participants in remote SMBP programs is needed. However, the effect of remote SMBP programs on perinatal equity may not be limited to race-based disparities.
Topics: Humans; Female; Hispanic or Latino; Pregnancy; Adult; Pilot Projects; Postpartum Period; Hypertension, Pregnancy-Induced; Blood Pressure Determination; Blood Pressure; Telemedicine
PubMed: 38810010
DOI: No ID Found -
BMJ Open May 2024Polypharmacy is common among individuals with multimorbidity, often leading to inappropriate medication use and is associated with an increased risk of frailty,...
INTRODUCTION
Polypharmacy is common among individuals with multimorbidity, often leading to inappropriate medication use and is associated with an increased risk of frailty, hospitalisation and mortality. Structured medication reviews (SMRs) have emerged as a promising method for optimising medication use. However, research examining their efficacy is limited. This review aims to evaluate the impact of SMRs on improving outcomes for adults with multimorbidity and polypharmacy in primary care settings. Additionally, this review seeks to identify prevailing patterns and trends in the mode of delivery of SMRs.
METHODS AND ANALYSIS
A systematic review will be conducted using Ovid MEDLINE, Ovid EMBASE, Web of Science and CINAHL (1997-present). Primary outcomes will include medication-related measures such as dose, frequency and dosage form. Secondary outcomes under investigation will include physical, mental, functional and health service outcomes, as reported. Two independent reviewers will conduct the screening and data extraction, resolving disagreements through discussion. Once eligible studies are identified, the extracted data will be summarised in tabular format. The risk of bias in the articles will be assessed using either the Cochrane Risk of Bias 2 tool or the Newcastle-Ottawa scale, depending on the design of the studies retrieved. Subgroup analysis will be performed using demographic variables and modes of delivery where the data supports. If appropriate, a meta-analysis of the data extracted will be conducted to determine the impact of the SMRs on reported outcomes. If a meta-analysis is not possible due to heterogeneity, a narrative synthesis approach will be adopted.
ETHICS AND DISSEMINATION
This proposed review is exempt from ethical approval as it aims to collate and summarise peer-reviewed, published evidence. This protocol and the subsequent review will be disseminated in peer-reviewed journals, conferences and patient-led lay summaries.
PROSPERO REGISTRATION NUMBER
CRD42023454965.
Topics: Humans; Systematic Reviews as Topic; Polypharmacy; Multimorbidity; Primary Health Care; Research Design; Inappropriate Prescribing; Adult
PubMed: 38806416
DOI: 10.1136/bmjopen-2023-082825 -
Farmacia Hospitalaria : Organo Oficial... May 2024The main objective was to analyze unjustified discrepancies during the medication reconciliation process in patients admitted to the Hematology Service of our hospital...
OBJECTIVE
The main objective was to analyze unjustified discrepancies during the medication reconciliation process in patients admitted to the Hematology Service of our hospital and the pharmaceutical interventions. As a secondary objective, to detect possible points of the procedure to be perfected with a view to protocolizing the medication reconciliation process in hematological patients that adapts to the conditions of our center.
METHODS
Cross-sectional observational pilot study carried out in a reference hospital in hematology for a population of 800,000 inhabitants. Adult inpatients admitted to the Hematology Service between August and October 2022 whose medication had been reconciled were included. The main variables were: number and type of unjustified discrepancy, proposed pharmaceutical intervention, and acceptance rate.
RESULTS
36 conciliation processes were analyzed, 34 admissions and 2 intrahospital transfer. 58.3% of the patients presented at least one unjustified discrepancy. 38 unjustified discrepancies were detected, with an acceptance of pharmaceutical interventions of 97.4%. The most common types of discrepancy were medication omission (56.8%) and drug interaction (24.3%). The most frequent pharmaceutical interventions were reintroducing medication (48.6%) and treatment discontinuation (16.2%). Polypharmacy and chemotherapy multiplied by 4 the probability of presenting drug interactions.
CONCLUSIONS
The most common unjustified discrepancies in the medication reconciliation process in hospitalized hematology patients are: Medication omission and drug interactions. The reintroduction of medication and suspension of the prescription are the most frequent accepted pharmaceutical interventions. Polypharmacy is related to an increase in unjustified discrepancies. The factors that promote the appearance of interactions are admissions to receive chemotherapy treatment and polypharmacy. The main point of improvement detected is the need to create a circuit that allows conciliation to be carried out on discharge. Medication reconciliation contribute to improving patient safety by reducing medication errors.
PubMed: 38806362
DOI: 10.1016/j.farma.2024.04.004 -
Health Informatics Journal 2024Complex socio-technical health information systems (HIS) issues can create new error risks. Therefore, we evaluated the management of HIS-related errors using the...
Complex socio-technical health information systems (HIS) issues can create new error risks. Therefore, we evaluated the management of HIS-related errors using the proposed human, organization, process, and technology-fit framework to identify the lessons learned. Qualitative case study methodology through observation, interview, and document analysis was conducted at a 1000-bed Japanese specialist teaching hospital. Effective management of HIS-related errors was attributable to many socio-technical factors including continuous improvement, safety culture, strong management and leadership, effective communication, preventive and corrective mechanisms, an incident reporting system, and closed feedback loops. Enablers of medication errors include system sophistication and process factors like workarounds, variance, clinical workload, slips and mistakes, and miscommunication. The case management effectiveness in handling the HIS-related errors can guide other clinical settings. The potential of HIS to minimize errors can be achieved through continual, systematic, and structured evaluation. The case study validated the applicability of the proposed evaluation framework that can be applied flexibly according to study contexts to inform HIS stakeholders in decision-making. The comprehensive and specific measures of the proposed framework and approach can be a useful guide for evaluating complex HIS-related errors. Leaner and fitter socio-technical components of HIS can yield safer system use.
Topics: Humans; Health Information Systems; Medical Errors; Qualitative Research; Japan; Patient Safety; Medication Errors; Hospitals, Teaching; Organizational Culture
PubMed: 38805345
DOI: 10.1177/14604582241252763 -
Pediatrics Jun 2024Many youth with acute and chronic health conditions require medication to be administered during the school day. This policy statement offers guidance to school...
Many youth with acute and chronic health conditions require medication to be administered during the school day. This policy statement offers guidance to school physicians, community prescribers, school nurses, other school health professionals, and groups providing oversight to school health activities and ensures patient safety and equity lenses are applied to administration of medications during school and for school-related activities. The American Academy of Pediatrics supports a robust collaborative model that allows all those involved in student health, including the student and family, to communicate, participate in effective medication management, inform delegated medication responsibilities, and promote safe medication storage and administration. School medication administration protocols are developed to help prevent medication administration errors specific to potential risks in the school setting and are responsive to the maturing students' evolving understanding of their health needs, growing autonomy, and responsibility. All protocols involving school nurses, unlicensed assistive personnel, and prescribers must be consistent with state and federal regulations on scope of practice, student privacy laws, and professional nursing organization guidelines. Consistent policies and messaging on safety of the patient and the entire school community enable school health teams to ensure equitable treatment of students prescribed therapeutic agents newly regulated by the US Food and Drug Administration, over-the-counter medications, or products that are currently not regulated by the US Food and Drug Administration.
Topics: Humans; United States; School Health Services; Child; Schools; Medication Errors; Patient Safety
PubMed: 38804057
DOI: 10.1542/peds.2024-066839 -
BMJ Open May 2024Polypharmacy and multimorbidity pose escalating challenges. Despite numerous attempts, interventions have yet to show consistent improvements in health outcomes. A key... (Review)
Review
INTRODUCTION
Polypharmacy and multimorbidity pose escalating challenges. Despite numerous attempts, interventions have yet to show consistent improvements in health outcomes. A key factor may be varied approaches to targeting patients for intervention.
OBJECTIVES
To explore how patients are targeted for intervention by examining the literature with respect to: understanding how polypharmacy is defined; identifying problematic polypharmacy in practice; and addressing problematic polypharmacy through interventions.
DESIGN
We performed a scoping review as defined by the Joanna Briggs Institute.
SETTING
The focus was on primary care settings.
DATA SOURCES
Medline, Embase, Cumulative Index to Nursing and Allied Health Literature and Cochrane along with ClinicalTrials.gov, Science.gov and WorldCat.org were searched from January 2004 to February 2024.
ELIGIBILITY CRITERIA
We included all articles that had a focus on problematic polypharmacy in multimorbidity and primary care, incorporating multiple types of evidence, such as reviews, quantitative trials, qualitative studies and policy documents. Articles focussing on a single index disease or not written in English were excluded.
EXTRACTION AND ANALYSIS
We performed a narrative synthesis, comparing themes and findings across the collective evidence to draw contextualised insights and conclusions.
RESULTS
In total, 157 articles were included. Case-finding methods often rely on basic medication counts (often five or more) without considering medical history or whether individual medications are clinically appropriate. Other approaches highlight specific drug indicators and interactions as potentially inappropriate prescribing, failing to capture a proportion of patients not fitting criteria. Different potentially inappropriate prescribing criteria also show significant inconsistencies in determining the appropriateness of medications, often neglecting to consider multimorbidity and underprescribing. This may hinder the identification of the precise population requiring intervention.
CONCLUSIONS
Improved strategies are needed to target patients with polypharmacy, which should consider patient perspectives, individual factors and clinical appropriateness. The development of a cross-cutting measure of problematic polypharmacy that consistently incorporates adjustment for multimorbidity may be a valuable next step to address frequent confounding.
Topics: Humans; Polypharmacy; Multimorbidity; Primary Health Care; Inappropriate Prescribing
PubMed: 38803265
DOI: 10.1136/bmjopen-2023-081698 -
Journal of Advanced Nursing May 2024To determine the prevalence of medication administration errors and identify factors associated with medication administration errors among neonates in the neonatal...
AIM(S)
To determine the prevalence of medication administration errors and identify factors associated with medication administration errors among neonates in the neonatal intensive care units.
DESIGN
Prospective direct observational study.
METHODS
The study was conducted in the neonatal intensive care units of five public hospitals in Malaysia from April 2022 to March 2023. The preparation and administration of medications were observed using a standardized data collection form followed by chart review. After data collection, error identification was independently performed by two clinical pharmacists. Multivariable logistic regression was used to identify factors associated with medication administration errors.
RESULTS
A total of 743 out of 1093 observed doses had at least one error, affecting 92.4% (157/170) neonates. The rate of medication administration errors was 68.0%. The top three most frequently occurring types of medication administration errors were wrong rate of administration (21.2%), wrong drug preparation (17.9%) and wrong dose (17.0%). Factors significantly associated with medication administration errors were medications administered intravenously, unavailability of a protocol, the number of prescribed medications, nursing experience, non-ventilated neonates and gestational age in weeks.
CONCLUSION
Medication administration errors among neonates in the neonatal intensive care units are still common. The intravenous route of administration, absence of a protocol, younger gestational age, non-ventilated neonates, higher number of medications prescribed and increased years of nursing experience were significantly associated with medication administration errors.
IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE
The findings of this study will enable the implementation of effective and sustainable interventions to target the factors identified in reducing medication administration errors among neonates in the neonatal intensive care unit.
REPORTING METHOD
We adhered to the STROBE checklist.
PATIENT OR PUBLIC CONTRIBUTION
An expert panel consisting of healthcare professionals was involved in the identification of independent variables.
PubMed: 38803148
DOI: 10.1111/jan.16247