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1.
J Adv Nurs ; 2024 May 27.
Artículo en Inglés | MEDLINE | ID: mdl-38803148

RESUMEN

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.

2.
Drug Dev Ind Pharm ; : 1-9, 2024 Mar 22.
Artículo en Inglés | MEDLINE | ID: mdl-38459761

RESUMEN

OBJECTIVES: This study aimed to determine the incidence, types and predictors of Potentially Harmful Excipients (PHE) exposure among hospitalized neonates. METHODS: A prospective observational study was conducted from March to April 2022 in neonatal wards at a state hospital in Malaysia. The PHEs of interest were aspartame, benzalkonium chloride, benzyl alcohol, benzoic acid or benzoates, ethanol, parabens, polysorbate 80, propylene glycol, saccharin sodium, sorbitol and sulfites. Product information leaflets (PILs) and summaries of product characteristics (SPCs) were referred to obtain information on active pharmaceutical ingredient, strength, trade name as well as type and amount of the excipients. RESULTS: A total of 108 neonates were recruited and 97.2% of them were exposed to at least one PHE. Parabens (47.2%) and sulfites (27.5%) were the two most commonly administered PHEs. Benzyl alcohol is contraindicated in neonates but was administered to 8% of neonates in this study. The median daily dose of ethanol (24.11 mg/kg/day, IQR 19.73, 28.49) exceeded the acceptable daily intake (ADI) by four times. However, the dose was not available for all PHEs as this information is not always available in the PIL or SPC. Administration of cardiovascular drugs was associated with a higher risk of exposure to any PHE (OR 6.38, CI 2.75, 14.79, p-value < 0.001). CONCLUSION: The exposure of PHE among neonates in this study is high with certain PHEs exceeding the ADI. It highlights the need for certain strategies to be implemented to reduce such exposure in neonates.

3.
J Cancer Educ ; 39(4): 383-390, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38530598

RESUMEN

Breast cancer survivors on adjuvant endocrine therapy (AET) have distinct information-seeking experience compared to those in the diagnosis and intensive treatment phase. This study aimed to understand the challenges in obtaining and seeking information among Malaysian breast cancer survivors. We conducted semi-structured, one-to-one interviews among patients using AET from two hospitals and a local cancer organization. Interviews were conducted until theme saturation was achieved (N = 25). Interviews were de-identified, transcribed verbatim, and analysed using thematic analysis. To ensure rigor, coding was conducted through regular discussions between two researchers and the findings were shared with several participants after analysis was completed. Three main themes were identified: limitations in the healthcare system, pitfalls of seeking information online, and limited information from local sources. The participants perceived that their information needs were not met by their healthcare providers and sought information on the Internet to complement their information needs. However, they were faced with risks of misinformation, information overload, and unethical promotion of health products. Those with limited English proficiency had difficulties in accessing quality information, and suggested that there should be more content created by local health advocates in local languages, with information that is tailored for local cultures. As the Internet has become an important medium of health education, healthcare providers and patients should be equipped with the skills to share and search for information online. Digital health literacy needs to be incorporated in patient education modules to create a more informed and empowered patient community.


Asunto(s)
Neoplasias de la Mama , Supervivientes de Cáncer , Conducta en la Búsqueda de Información , Investigación Cualitativa , Humanos , Femenino , Neoplasias de la Mama/psicología , Neoplasias de la Mama/terapia , Supervivientes de Cáncer/psicología , Persona de Mediana Edad , Malasia , Adulto , Anciano , Internet
4.
Epilepsy Behav ; 142: 109154, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-37001468

RESUMEN

INTRODUCTION: Seizure outcomes from antiseizure medication (ASM) therapy can be measured across various domains using assessment tools. The available tools may contain an array of different components or items. Seizure severity assessment, as opposed to seizure frequency count may have been a more accurate measurement in determining the effectiveness of ASM therapy. This study aimed to review studies developing seizure severity assessment tools for adults with epilepsy, describe the development methods and validation, and compare the list of items in these tools. METHODS: The systematic search utilized established databases such as Scopus, Ovid, Web of Science, Medline, Wiley Online, and Cochrane Library. Studies published from inception to December 15, 2022, were selected. Publications describing the development of tools to measure seizure severity among adult epilepsy patients were included. Outcome measures including the tool's content, development methods, validity, and reliability assessments were compared. RESULTS: The search produced eight publications describing the development of eight seizure severity assessment tools. One of these tools is part of a multidimensional assessment of the overall impact of epilepsy. The frequently used method in the initial development was the qualitative method (n = 6) where two publications reanalyzed the items from previous studies. Face validity was the most common validation test conducted (n = 4). At least one reliability assessment was conducted for each of the tools, most commonly by the test-retest method (n = 6) and inter-rater reliability (n = 5). All of these tools cover the components of pre-ictal (warning/aura), ictal, and postictal (recovery) events. CONCLUSION: The identified tools described the assessment of seizure severity using various subscales. The emergence of new methods in quantifying seizure severity unfolds opportunities in discovering more comprehensive assessments of seizure severity in both clinical trials and daily clinical practice.


Asunto(s)
Epilepsia , Humanos , Adulto , Reproducibilidad de los Resultados , Epilepsia/diagnóstico , Epilepsia/tratamiento farmacológico , Convulsiones/diagnóstico , Convulsiones/tratamiento farmacológico , Evaluación de Resultado en la Atención de Salud , Proyectos de Investigación , Anticonvulsivantes/uso terapéutico
5.
Int J Qual Health Care ; 35(4)2023 Dec 29.
Artículo en Inglés | MEDLINE | ID: mdl-38102640

RESUMEN

Medication administration is a complex process, and nurses play a central role in this process. Errors during administration are associated with severe patient harm and significant economic burden. However, the prevalence of under-reporting makes it challenging when analysing the current landscape of medication administration error (MAE) and hinders the implementation of improvements to the existing system. The aim of this study is to describe the reasons for the occurrence of MAEs and the reasons behind the under-reporting of MAEs, to determine the estimated percentage of MAE reporting and to identify factors associated with them from the nurses' perspective. This cross-sectional study was conducted using a validated self-administered questionnaire. The questionnaire contained 65 questions which were divided into three sections: (i) reasons for the occurrence of MAEs, which consisted of 29 items; (ii) reasons for not reporting MAEs, which consisted of 16 items; and (iii) percentage of MAEs actually reported, which consisted of 20 items. It was distributed to 143 nurses in the neonatal intensive care units of five public hospitals in Malaysia. Multivariable logistic regression was used to identify the factors associated with MAE reporting. The estimated percentage of MAE reporting was 30.6%. The most common reasons for MAEs were inadequate nursing staff (5.14 [SD 1.25]), followed by drugs which look alike (4.65 [SD 1.06]) and similar drug packaging (4.41 [SD 1.18]). The most common reasons for not reporting MAEs were that nursing administration focuses on the individual rather than looking at the systems as a potential cause of the error (4.56 [SD 1.32]) and that too much emphasis is placed on MAEs as a measure of the quality of nursing care (4.31 [SD 1.23]). Factors statistically significant with MAE reporting were administration response (adjusted odds ratio [AOR] = 6.90; 95% confidence interval (CI) = 2.01-23.67; P = 0.002), reporting effort (AOR = 3.67; 95% CI = 1.68-8.01; P = 0.001), and nurses with advanced diploma (AOR = 0.29; 95% CI = 0.13-0.65; P = 0.003). Our findings show that under-reporting of MAEs is still common and less than a third of the respondents reported MAEs. Therefore, to encourage error reporting, emphasis should be placed on the benefits of reporting, adopting a non-punitive approach, and creating a blame-free culture.


Asunto(s)
Enfermeras y Enfermeros , Gestión de Riesgos , Recién Nacido , Humanos , Errores de Medicación , Unidades de Cuidado Intensivo Neonatal , Estudios Transversales , Preparaciones Farmacéuticas , Percepción
6.
BMC Cancer ; 22(1): 731, 2022 Jul 04.
Artículo en Inglés | MEDLINE | ID: mdl-35787795

RESUMEN

BACKGROUND: An uninterrupted dose of oxaliplatin-based cytotoxic therapy is an essential component in the standard treatment regimen of metastatic colon cancer (mCC). Data on the impacts of dose intensity reduction on the palliative treatment for patients with mCC remain scarce. Hence, this study aimed to investigate the impact of palliative chemotherapy dose modifications (DM) on the survival of patients with mCC. METHODS: Patients with stage IV colon cancer who received first-line palliative FOLFOX regimen chemotherapy between 2014 until 2018 in the Oncology Department of the National Cancer Institute were conveniently sampled retrospectively to analyse the treatment efficacy. The cumulative dose and duration of chemotherapy received by the patients were summarised as relative dose intensity (RDI) and stratified as High RDI (RDI ≥ 70%) or Low RDI (RDI < 70%). Progression-free survival (PFS) and 2-year overall survival (OS) between the two groups were analysed using Kaplan-Meier survival analysis and Cox proportional hazards models. RESULTS: Out of the 414 patients identified, 95 patients with mCC were eligible and included in the final analysis. About half of the patients (n = 47) completed the 12-cycle chemotherapy regimen and one patient received the complete (100%) RDI. The overall median RDI was 68.7%. The Low RDI group (n = 49) had a 1.5 times higher mortality risk than the High RDI group [OS, Hazard Ratio (HR) = 1.5, 95% Cl: 1.19-1.82] with a significant median OS difference (9.1 vs. 16.0 months, p <  0.01). Furthermore, patients with lower dose intensity showed double the risk of disease progression (PFS, HR = 2.0, 95% CI: 1.23-3.13) with a significant difference of 4.5 months of median PFS (p <  0.01). Gender and RDI were the independent prognostic factors of both OS and PFS. CONCLUSION: Reduction in the dose intensity of palliative chemotherapy may adversely affect both disease progression and overall survival among mCC patients.


Asunto(s)
Neoplasias del Colon , Neoplasias del Recto , Neoplasias del Colon/tratamiento farmacológico , Progresión de la Enfermedad , Humanos , Cuidados Paliativos , Estudios Retrospectivos
7.
Support Care Cancer ; 30(6): 5339-5349, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35290510

RESUMEN

BACKGROUND: Chemotherapy-induced nausea vomiting (CINV) is a common and significant problem in oncology patients and rated as one of cancer chemotherapy's most distressing side effects. The objectives of this study are to describe the incidence of CINV in highly and moderately emetogenic chemotherapy-treated patients and the prescribing pattern of CINV prophylaxis. METHODS: This retrospective, cross-sectional single-center study randomly collected data on demographics, CINV episodes, and prescribing patterns for adult oncology patients receiving intravenous highly or moderately emetogenic chemotherapy (HEC/MEC) between January and December 2019. RESULTS: A total of 419 randomly selected records of HEC/MEC recipients with 2388 total chemotherapy cycles were included. The mean age was 53.6 ± 12.6 years old. The majority was female (66%), Malay (54.4%), diagnosed with cancer stage IV (47.7%), and with no comorbidities (47%). All patients were prescribed with IV granisetron and dexamethasone before chemotherapy for acute prevention, whereas dexamethasone and metoclopramide were prescribed for delayed prevention. Aprepitant was not routinely prescribed for the prevention of CINV. CINV incidence was 57% in the studied population and 20% in the total cycle. This study found a significant association between CINV incidence with performance status and cisplatin-based chemotherapy (OR = 3.071, CI = 1.515-6.223, p = 0.002; OR = 4.587, CI = 1.739-12.099, p = 0.02, respectively). CONCLUSION: CINV incidence was rather high per patient but relatively low per cycle. Most patients were prescribed with dual regimen antiemetic prophylaxis. IMPACT: This study provides evidence that there was suboptimal use of recommended agents for CINV, and there is a clear need for further improvements in CINV management.


Asunto(s)
Antieméticos , Antineoplásicos , Neoplasias , Adulto , Anciano , Antineoplásicos/efectos adversos , Estudios Transversales , Dexametasona/uso terapéutico , Eméticos/efectos adversos , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Náusea/epidemiología , Náusea/prevención & control , Neoplasias/tratamiento farmacológico , Estudios Retrospectivos , Vómitos/inducido químicamente , Vómitos/epidemiología , Vómitos/prevención & control
8.
Dysphagia ; 37(4): 1022-1034, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-34518932

RESUMEN

Dysphagia is associated with increased dependency and treatment costs, whereby patients resort to extemporaneous compounding that may further increase the number of adverse events and medical errors. In the management of dysphagia, increasing the bolus viscosity of medication such as fluid gels can be practiced. This study aimed to prepare and characterize the fluid gels as well as to estimate the cost of using fluid gels and compare it to the conventional practice of extemporaneous preparation of thickened liquid. Fluid gels were formulated using gellan gum and determined for physicochemical characteristics and in vitro drug release profile. The cost-based price of the fluid gel was estimated and compared to the cost of administering standard medication as well as administering thickened liquid using thickening powder. Fluid gels exhibited good physicochemical properties with the viscosity within nectar and honey consistency. A similar dissolution profile to the reference was observed for the 0.5% w/v gellan gum fluid gel and exhibiting the Higuchi release model. The price for 100 mL unit of 50 mg/mL paracetamol/acetaminophen and 20 mg/mL ibuprofen fluid gel was estimated to be about USD2.30 and USD2.37, respectively. A dose of 1000 mg paracetamol and 400 mg ibuprofen fluid gel was estimated to be about USD0.46 and USD0.47, respectively, which is lower than the cost of administering the same dose using extemporaneous thickened liquid. Fluid gels could be a cost-effective formulation for delivering medication in patients with dysphagia and can be developed on a profitable scale.


Asunto(s)
Trastornos de Deglución , Acetaminofén/química , Anciano , Química Farmacéutica , Análisis Costo-Beneficio , Trastornos de Deglución/terapia , Geles/química , Humanos , Ibuprofeno , Polisacáridos Bacterianos/química , Viscosidad
9.
Br J Clin Pharmacol ; 87(7): 2956-2966, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-33377197

RESUMEN

AIMS: There is considerable interpatient variability in the pharmacokinetics (PK) of intravenous immunoglobulin G (IVIG), causing difficulty in optimizing individual dosage regimen. This study aims to estimate the population PK parameters of IVIG and to investigate the impact of genetic polymorphism of the FcRn gene and clinical variability on the PK of IVIG in patients with predominantly antibody deficiencies. METHODS: Patients were recruited from four hospitals. Clinical data were recorded and blood samples were taken for PK and genetic studies. Population PK parameters were estimated by nonlinear mixed-effects modelling in Monolix®. Models were evaluated using the difference in objective function value, goodness-of-fit plots, visual predictive check and bootstrap analysis. Monte Carlo simulation was conducted to evaluate different dosing regimens for IVIG. RESULTS: A total of 30 blood samples were analysed from 10 patients. The immunoglobulin G concentration data were best described by a one-compartment model with linear elimination. The final model included both volume of distribution (Vd) and clearance (CL) based on patient's individual weight. Goodness-of-fit plots indicated that the model fit the data adequately, with minor model mis-specification. Genetic polymorphism of the FcRn gene and the presence of bronchiectasis did not affect the PK of IVIG. Simulation showed that 3-4-weekly dosing intervals were sufficient to maintain IgG levels of 5 g L-1 , with more frequent intervals needed to achieve higher trough levels. CONCLUSIONS: Body weight significantly affects the PK parameters of IVIG. Genetic and other clinical factors investigated did not affect the disposition of IVIG.


Asunto(s)
Inmunoglobulinas Intravenosas , Modelos Biológicos , Administración Intravenosa , Simulación por Computador , Humanos , Inmunoglobulinas Intravenosas/farmacocinética , Método de Montecarlo
10.
J Cancer Educ ; 36(2): 350-358, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-31659620

RESUMEN

Most people with cancer have a combination of treatments, such as surgery with chemotherapy and/or radiation therapy. Providing good quality cancer-related information enables patients to be better prepared for treatment and improves their adherence. This study aimed to determine the level of information received and the perceived usefulness of the sources of information to cancer patients. A 4-month study was conducted at a day care oncology unit and oncology ward of a tertiary care centre in Malaysia using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Information Module (EORTC QLQ-INFO 25). In total, 103 patients successfully completed the questionnaire. Level of information received was moderate. Patients were well-informed about medical tests (mean ± SD = 74.2 ± 17.8) followed by the disease itself (mean ± SD = 68.0 ± 13.6). Patients received less information on both other services (mean ± SD = 47.6 ± 18.1) and different places of care (mean ± SD = 41.3 ± 22.3). Although the correlation between age and level of information received was poor (r = - 0.201; P = .042), younger patients (≤ 65 years old) were found to have higher level of information received than older patients (mean ± SD = 61.5 ± 11.2 versus 57.8 ± 6.6; P = .046). Doctors (mean ± SD = 88.1 ± 17.1), nurses (mean ± SD = 83.7 ± 20.3), and family members (mean ± SD = 81.1 ± 24.9) were the most useful sources of information by cancer patients. There is still a need for improvement in the provision of information by the healthcare team and prioritisation should depend on patients' individual characteristics and their needs of information. More attention is needed in delivering required information especially to older patients.


Asunto(s)
Neoplasias , Calidad de Vida , Anciano , Humanos , Malasia , Neoplasias/terapia , Encuestas y Cuestionarios , Centros de Atención Terciaria
11.
J Clin Immunol ; 40(5): 682-698, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32417999

RESUMEN

PURPOSE: We conducted a systematic review and meta-regression analysis to evaluate the impact of increasing immunoglobulin G (IgG) trough levels on the clinical outcomes in patients with PID receiving intravenous immunoglobulin G (IVIG) treatment. METHODS: Systematic search was conducted in PubMed and Cochrane. Other relevant articles were searched by reviewing the references of the reviewed article. All clinical trials with documented IgG trough levels and clinical outcome of interest in patients receiving IVIG treatment were eligible to be included in this review. Meta-regression analysis was conducted using Comprehensive Meta-analysis Software. Additional sensitivity analyses were undertaken to evaluate the robustness of the overall results. RESULTS: Twenty-eight clinical studies with 1218 patients reported from year 2001 to 2018 were included. The mean IVIG dose used ranges from 387 to 560 mg/kg every 3 to 4 weekly, and mean IgG trough obtained ranges from 660 to 1280 mg/dL. Random-effects meta-regression slope shows that IgG trough level increases significantly by 73 mg/dL with every increase of 100 mg/kg dose of IVIG (p < 0.05). Overall infection rates reduced significantly by 13% with every increment of 100 mg/dL of IgG trough up to 960 mg/dL (p < 0.05). CONCLUSION: This meta-analysis concludes that titrating the IgG trough levels up to 960 mg/dL progressively reduces the rate of infections, and there is less additional benefit beyond that. Further studies to validate this result are required before it can be used in clinical practice.


Asunto(s)
Inmunoglobulina G/metabolismo , Inmunoglobulinas Intravenosas/uso terapéutico , Infecciones/inmunología , Enfermedades de Inmunodeficiencia Primaria/inmunología , Animales , Ensayos Clínicos como Asunto , Humanos , Enfermedades de Inmunodeficiencia Primaria/terapia , Resultado del Tratamiento
12.
Epilepsy Behav ; 111: 107317, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32693382

RESUMEN

PURPOSE: Self-management is crucial in the management of chronic diseases. However, information is limited on medication self-management among parents of children with epilepsy. This study aimed to assess medication self-management among parents of children with epilepsy and its association with sociodemographic data, clinical characteristics, antiepileptic drug (AED) regimen complexity, and parent self-reported AED adherence. METHOD: A cross-sectional survey was conducted at a tertiary care center in Malaysia from February 2019 to June 2019. Parents of children with epilepsy who were on AED for at least 3 months and aged ≤18 years old were recruited. Medication self-management was assessed using a validated Pediatric Epilepsy Medication Self-Management Questionnaire (PEMSQ). A higher total score reflects better medication self-management. RESULTS: A total of 166 patients were recruited. The mean ±â€¯standard deviation (SD) age of patients was 8.20 ±â€¯5.21 years, and 51.8% and 36.7% of patients have generalized seizure and focal seizure, respectively. The mean ±â€¯SD PEMSQ score was 116.2 ±â€¯11.28 from a total score of 135. Among the four domains of PEMSQ, the barriers to treatment contributed to the lowest mean scores. Univariate analysis showed that the following were significantly associated with poorer medication self-management: differences in ethnicity, religion; higher number of medications; presence of comorbidities; inability to swallow tablets; and a more complex AED regimen. Other variables were not significant. Multivariate analysis showed that only ethnicity and presence of comorbidity remained independently significant (R2 = 0.14; F [4, 161] = 6.28; p < 0.001). Poorer medication self-management was observed in the Malaysian Chinese population than in the Malaysian Malay population (b = -8.52; p < 0.001) and in children with comorbidities than in those without comorbidities (b = -5.04, p = 0.01). CONCLUSION: The overall medication self-management was satisfactory. Barriers to treatment should be addressed to empower parents to achieve better medication self-management. Furthermore, medication self-management should be reinforced among Malaysian Chinese patients and children with comorbidities.


Asunto(s)
Anticonvulsivantes/uso terapéutico , Epilepsia/tratamiento farmacológico , Epilepsia/epidemiología , Padres , Automanejo/métodos , Centros de Atención Terciaria , Adolescente , Adulto , Niño , Preescolar , Estudios Transversales , Epilepsia/psicología , Femenino , Humanos , Malasia/epidemiología , Masculino , Cumplimiento de la Medicación/psicología , Persona de Mediana Edad , Padres/psicología , Autoinforme , Automanejo/psicología
13.
Clin Ther ; 2024 Oct 03.
Artículo en Inglés | MEDLINE | ID: mdl-39366801

RESUMEN

PURPOSE: Intravenous immunoglobulin (IVIG) is used to treat various immune system disorders, but the factors influencing its disposition are not well understood. This study aimed to estimate the population pharmacokinetic parameters of IVIG and to investigate the effect of genetic polymorphism of the FCGRT gene encoding the neonatal Fc receptor (FcRn) and clinical variability on the pharmacokinetic properties of IVIG in patients with immune system disorders. METHODS: Patients were recruited from 4 hospitals in Malaysia. Clinical data were recorded, and blood samples were taken for pharmacokinetic and genetic studies. Population pharmacokinetic parameters were estimated by nonlinear mixed-effects modeling in Monolix. Age, weight, baseline immunoglobulin G concentration, ethnicity, sex, genotype, disease type, and comorbidity were investigated as potential covariates. Models were evaluated using the difference in objective function value, goodness-of-fit plots, visual predictive checks, and bootstrap analysis. FINDINGS: A total of 292 blood samples were analyzed from 79 patients. The IVIG concentrations were best described by a 2-compartment model with linear elimination. Weight was found to be an important covariate for volume of distribution in the central compartment (Vc), volume of distribution in the peripheral compartment (Vp), and clearance in the central compartment, whereas disease type was found to be an important covariate for Vp. Goodness-of-fit plots indicated that the model fit the data adequately. Genetic polymorphism of the FCGRT gene encoding the neonatal Fc receptor did not affect the pharmacokinetic properties of IVIG. IMPLICATIONS: This study supports the use of dosage based on weight as per current practice. The study findings highlight that Vp is significantly influenced by the type of disease being treated with IVIG. This relationship suggests that different disease types, particularly inflammatory and autoimmune conditions, may alter tissue permeability and fluid distribution due to varying degrees of inflammation. Increased inflammation can lead to enhanced permeability and retention of IVIG in peripheral tissues, reflecting higher Vp values.

14.
Ther Clin Risk Manag ; 20: 529-541, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39220771

RESUMEN

Aim: Identifying a patient's risk for poor outcomes after starting antiseizure medication (ASM) therapy is crucial in managing epilepsy pharmacologically. To date, there is a lack of designated tools to assess such risks. Purpose: To develop and validate a risk assessment tool for the therapeutic outcomes of ASM therapy. Patients and Methods: A cross-sectional study was carried out in a hospital-based specialist clinic from September 2022 to August 2023. Data was analyzed from patients' medical records and face-to-face assessments. The seizure control domain was determined from the patients' medical records while seizure severity (SS) and adverse effects (AE) of ASM were assessed using the Seizure Severity Questionnaire and the Liverpool Adverse Event Profile respectively. The developed tool was devised from prediction models using logistic and linear regressions. Concurrent validity and interrater reliability methods were employed for validity assessments. Results: A total of 397 patients were included in the analysis. For seizure control, the identified predictors include ≥10 years' epilepsy duration (OR:1.87,95% CI:1.10-3.17), generalized onset (OR:7.42,95% CI:2.95-18.66), focal onset seizure (OR:8.24,95% CI:2.98-22.77), non-adherence (OR:3.55,95% CI:1.52-8.27) and having ≥3 ASM (OR:3.29,95% CI:1.32-8.24). Younger age at epilepsy onset (≤40) (OR:3.29,95% CI:1.32-8.24) and neurological deficit (OR:3.55,95% CI:1.52-8.27) were significant predictors for SS. For AE, the positive predictors were age >35 (OR:0.12,95% CI:0.03-0.20), <13 years epilepsy duration (OR:2.89,95% CI:0.50-5.29) and changes in ASM regimen (OR:2.93,95% CI: 0.24-5.62). The seizure control domain showed a good discriminatory ability with a c-index of 0.711. From the Bonferroni (ANOVA) analysis, only SS predicted scores generated a linear plot against the mean of the actual scores. The AE domain was omitted from the final tool because it did not meet the requirements for validity assessment. Conclusion: This newly developed tool (RAS-TO) is a promising tool that could help healthcare providers in determining optimal treatment strategies for adults with epilepsy.

15.
PLoS One ; 19(7): e0305538, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38990851

RESUMEN

Despite efforts in improving medication safety, medication administration errors are still common, resulting in significant clinical and economic impact. Studies conducted using a valid and reliable tool to assess clinical impact are lacking, and to the best of our knowledge, studies evaluating the economic impact of medication administration errors among neonates are not yet available. Therefore, this study aimed to determine the potential clinical and economic impact of medication administration errors in neonatal intensive care units and identify the factors associated with these errors. A national level, multi centre, prospective direct observational study was conducted in the neonatal intensive care units of five Malaysian public hospitals. The nurses preparing and administering the medications were directly observed. After the data were collected, two clinical pharmacists conducted independent assessments to identify errors. An expert panel of healthcare professionals assessed each medication administration error for its potential clinical and economic outcome. A validated visual analogue scale was used to ascertain the potential clinical outcome. The mean severity index for each error was subsequently calculated. The potential economic impact of each error was determined by averaging each expert's input. Multinomial logistic regression and multiple linear regression were used to identify factors associated with the severity and cost of the errors, respectively. A total of 1,018 out of 1,288 (79.0%) errors were found to be potentially moderate in severity, while only 30 (2.3%) were found to be potentially severe. The potential economic impact was estimated at USD 27,452.10. Factors significantly associated with severe medication administration errors were the medications administered intravenously, the presence of high-alert medications, unavailability of a protocol, and younger neonates. Moreover, factors significantly associated with moderately severe errors were intravenous medication administration, younger neonates, and an increased number of medications administered. In the multiple linear regression analysis, the independent variables found to be significantly associated with cost were the intravenous route of administration and the use of high-alert medications. In conclusion, medication administration errors were judged to be mainly moderate in severity costing USD 14.04 (2.22-22.53) per error. This study revealed important insights and highlights the need to implement effective error reducing strategies to improve patient safety among neonates in the neonatal intensive care unit.


Asunto(s)
Unidades de Cuidado Intensivo Neonatal , Errores de Medicación , Humanos , Errores de Medicación/economía , Errores de Medicación/prevención & control , Errores de Medicación/estadística & datos numéricos , Unidades de Cuidado Intensivo Neonatal/economía , Recién Nacido , Femenino , Masculino , Estudios Prospectivos , Malasia
16.
Value Health Reg Issues ; 44: 101028, 2024 Jul 27.
Artículo en Inglés | MEDLINE | ID: mdl-39068865

RESUMEN

OBJECTIVES: Olanzapine has been shown to be effective in preventing chemotherapy-induced nausea and vomiting (CINV) after highly emetogenic chemotherapy (HEC); however, there is limited work on the impact of CINV on health-related quality of life (HRQoL) and the comparative cost-effectiveness of CINV prophylaxis in the Malaysian context. Therefore, this study was conducted to determine the HRQoL using EQ-5D-5L and the cost-effectiveness of olanzapine compared with aprepitant for CINV prophylaxis in Malaysia using data from a local study. METHODS: Fifty-nine chemo-naive patients receiving either olanzapine or aprepitant were randomly recruited and completed the EQ-5D-5L before and day 5 after HEC. HRQoL utility scores were analyzed according to the Malaysian valuation set. The economic evaluation was conducted from a healthcare payer perspective with a 5-day time horizon. Quality-adjusted life days (QALD) and the rate of successfully treated patients were used to measure health effects. The incremental cost-effectiveness ratio is assessed as the mean difference between groups' costs per mean difference in health effects. A one-way sensitivity analysis was performed to assess variations that might affect outcomes. RESULTS: Aprepitant and olanzapine arms' patients had comparable baseline mean HRQoL utility scores of 0.920 (SD = 0.097) and 0.930 (SD = 0.117), respectively; however, on day 5, a significant difference (P value = .006) was observed with mean score of 0.778 (SD = 0.168) for aprepitant and 0.889 (SD = 0.133) for olanzapine. The cost per successfully treated patient in the aprepitant arm was 60 times greater than in the olanzapine arm (Malaysian Ringgit [MYR] 927 vs MYR 14.83). Likewise, the cost per QALD gain in the aprepitant arm was 36 times higher than in the olanzapine arm (MYR 57.05 vs MYR 1.57). Incremental cost-effectiveness ratio of MYR -937.00 (USD -200.98) per successfully treated patient and MYR -391.84 (USD -85.43) per QALD gained for olanzapine compared with the aprepitant-based regimen. CONCLUSIONS: An olanzapine-based regimen is a cost-effective therapeutic substitution in patients receiving HEC in Malaysia.

17.
BMJ Open ; 14(4): e079606, 2024 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-38569693

RESUMEN

OBJECTIVE: The objective of this study is to explore the information needs related to insulin therapy in children and adolescents with type 1 diabetes mellitus (T1DM) from the children's perspectives as well as their caregivers. DESIGN: Qualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed. SETTING: Participants were recruited from a tertiary care children's hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia. PARTICIPANTS: Thirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia. RESULTS: Four themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy. CONCLUSION: This study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.


Asunto(s)
Diabetes Mellitus Tipo 1 , Niño , Humanos , Adolescente , Adulto , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Automonitorización de la Glucosa Sanguínea , Glucemia , Insulina/uso terapéutico , Investigación Cualitativa
18.
Digit Health ; 9: 20552076231205742, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37808244

RESUMEN

Objective: To determine the prevalence and types of misinformation on Twitter related to breast cancer prevention and treatment; and compare the differences between the misinformation in English and Malay tweets. Methods: A total of 6221 tweets related to breast cancer posted between 2018 and 2022 were collected. An oncologist and two pharmacists coded the tweets to differentiate between true information and misinformation, and to analyse the misinformation content. Binary logistic regression was conducted to identify determinants of misinformation. Results: There were 780 tweets related to breast cancer prevention and treatment, and 456 (58.5%) contain misinformation, with significantly more misinformation in Malay compared to English tweets (OR = 6.18, 95% CI: 3.45-11.07, p < 0.001). Other determinants of misinformation were tweets posted by product sellers and posted before the COVID-19 pandemic. Less misinformation was associated with tweets utilising official/peer-reviewed sources of information compared to tweets without external sources and those that utilised less reliable information sources. The top three most common content of misinformation were food and lifestyle, alternative medicine and supplements, comprising exaggerated claims of anti-cancer properties of traditional and natural-based products. Conclusion: Misinformation on breast cancer prevention and treatment is prevalent on social media, with significantly more misinformation in Malay compared to English tweets. Our results highlighted that patients need to be educated on digital health literacy, with emphasis on utilising reliable sources of information and being cautious of any promotional materials that may contain misleading information. More studies need to be conducted in other languages to address the disparity in misinformation.

19.
BMJ Paediatr Open ; 7(1)2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-36754439

RESUMEN

INTRODUCTION: Medication administration errors (MAEs) are the most common type of medication error. Furthermore, they are more common among neonates as compared with adults. MAEs can result in severe patient harm, subsequently causing a significant economic burden to the healthcare system. Targeting and prioritising neonates at high risk of MAEs is crucial in reducing MAEs. To the best of our knowledge, there is no predictive risk score available for the identification of neonates at risk of MAEs. Therefore, this study aims to develop and validate a risk prediction model to identify neonates at risk of MAEs. METHODS AND ANALYSIS: This is a prospective direct observational study that will be conducted in five neonatal intensive care units. A minimum sample size of 820 drug preparations and administrations will be observed. Data including patient characteristics, drug preparation-related and administration-related information and other procedures will be recorded. After each round of observation, the observers will compare his/her observations with the prescriber's medication order, hospital policies and manufacturer's recommendations to determine whether MAE has occurred. To ensure reliability, the error identification will be independently performed by two clinical pharmacists after the completion of data collection for all study sites. Any disagreements will be discussed with the research team for consensus. To reduce overfitting and improve the quality of risk predictions, we have prespecified a priori the analytical plan, that is, prespecifying the candidate predictor variables, handling missing data and validation of the developed model. The model's performance will also be assessed. Finally, various modes of presentation formats such as a simplified scoring tool or web-based electronic risk calculators will be considered.


Asunto(s)
Unidades de Cuidado Intensivo Neonatal , Errores de Medicación , Humanos , Adulto , Recién Nacido , Femenino , Masculino , Estudios Prospectivos , Reproducibilidad de los Resultados , Errores de Medicación/prevención & control , Preparaciones Farmacéuticas , Estudios Observacionales como Asunto
20.
Breast ; 62: 22-35, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35121501

RESUMEN

PURPOSE: This systematic review aimed to determine the rate and identify correlates of adherence and persistence over five years of treatment with adjuvant endocrine therapy in female breast cancer patients. METHODS: Relevant articles were identified from Medline, Embase, AMED, PsycINFO, International Pharmaceutical Abstracts, and APA PsycArticles. Studies that measured patient adherence in the implementation or persistence phase for a period of at least five years using objective or multiple measures of adherence and investigated correlates of adherence were included. The titles, abstracts and full articles were screened and reviewed by two authors and any discrepancies were discussed with a third author. RESULTS: Twenty-six studies were included. Mean rate of adherence at five-year for implementation phase was 66.2% (SD = 17.3%), and mean persistence was 66.8% (SD = 14.5%). On average, adherence decreased by 25.5% (SD = 9.3%) from the first to fifth year. Higher rate of adherence was observed through self-report in comparison to database or medical record. Older age, younger age, higher comorbidity index, depression and adverse effects were associated with lower adherence. Treatment with aromatase inhibitors, received chemotherapy, and prior medication use were associated with improved adherence. CONCLUSION: Adherence to adjuvant endocrine therapy decreased from the first to fifth year of treatment. On average, one-third of patients were not adherent to treatment by the fifth year. Nineteen recurring factors were found to be significantly associated with long-term adherence in multiple studies. Further research using objective or multiple measures of adherence are needed to improve validity of results.


Asunto(s)
Neoplasias de la Mama , Antineoplásicos Hormonales/uso terapéutico , Inhibidores de la Aromatasa/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Quimioterapia Adyuvante , Terapia Combinada , Femenino , Humanos , Cumplimiento de la Medicación , Recurrencia Local de Neoplasia/tratamiento farmacológico , Cooperación del Paciente
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