Implementation of Beyond-Use Date Guidelines for Single-Use Vials at a Pediatric Hospital.
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ABSTRACT:
SUBMITTER: Hollis K
PROVIDER: S-EPMC7801331 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
Publications
Implementation of Beyond-Use Date Guidelines for Single-Use Vials at a Pediatric Hospital.
Hollis Kathryn K Payen Florence F Vaillancourt Régis R
The Canadian journal of hospital pharmacy 20210101 1
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Project description:Objective: To systematically analyze the supporting evidence, drug information, and the type of off-label drug use in recommendations on off-label drug use in pediatric guidelines. Methods: A cross-sectional study was performed by systematic search through MEDLINE (via PubMed) and Embase databases to identify literature published from 1 January 2018, to 31 December 2020. Only pediatric clinical practice guidelines that included recommendations on off-label use of drugs were included. We present descriptive information on the sources of the included guidelines, country, publication year, evidence grading system used, details on the types of off-label drug use, and the types of studies used as references to support the recommendations. Results: A total of 66 pediatric guidelines with 605 recommendations were included. Eighty-seven (14.4%) recommendations did not cite any references; and the remaining 518 recommendations were supported by 2,240 references (mean 4.3 references/recommendation). The most common types of studies cited were pediatric RCTs (n = 314, 14.0%), pediatric case series studies (n = 260, 11.6%), and reviews (n = 255, 11.4%). Twenty-one percent (n = 470) of the references were studies on adults. One hundred and forty (23.1%) recommendations were graded using the Grading of Recommendations, Assessments, Development, and Evaluations (GRADE) system, of which 37 (26.4%) were graded as strong but supported with only C or D level of evidence. The most commonly reported type of information in the recommendations was indication (n = 499, 82.5%). The most commonly addressed type of off-label drug use in the 523 positive recommendations was unapproved population (n = 255, 48.8%). Sixty-nine (11.4%) recommendations explicitly reported the drug use as off-label. Conclusion: Children may be exposed to medical risks due to gaps in reporting and evidence of off-label drug use recommendations in pediatric guidelines.
| S-EPMC9218488 | biostudies-literature
Project description:Critical illness results in physical impairments which may be mitigated by intensive care unit (ICU)-based early mobility. This initiative aimed to develop and implement ICU-based mobility guidelines for critically ill children.MethodsA multidisciplinary team developed and implemented ICU-based mobility guidelines. Guideline implementation success was determined by comparing utilization of physical (PT) and occupational therapies (OT) and changes in functional status scale scores in preimplementation and postimplementation cohorts. The team also assessed barriers and adverse events.ResultsThirty-four patients were identified preimplementation and 55 patients postimplementation. PT/OT consultation by 72 hours occurred in 44 (81.5%) of patients postimplementation compared to 6 (17%) preimplementation (P < 0.001). Implementation did not result in more ICU-based therapy sessions or shorter time to active therapies. High deferral rates for PT/OT sessions [PT: n = 72 (46.2%) preimplementation versus 112 (39.4%) postimplementation; OT: n = 71 (46.1%) preimplementation versus 134 (41.5%) postimplementation] occurred. No difference in new morbidity between cohorts was identified. Barriers to treatment included the patient's sedation status, severity of illness, and patient availability.ConclusionsImplementation of ICU-based mobility guidelines resulted in a 4-fold increase in PT/OT consultation. They did not result in increased treatment sessions due to frequent deferrals. Future guidelines should focus on interventions to address identified barriers to treatment in a critically ill pediatric population.
| S-EPMC8143751 | biostudies-literature
Project description:To support compounding of products that are sterile and chemically stable, beyond use dating of admixtures must include a thorough evaluation of appropriate resources. In most instances, resources provide documentation of a specific compounded admixture, at a specific concentration and storage parameters, that does not coincide with current operations or patient-specific requirements. To meet the operational demands of a pharmacy, institutions employ a referenced guideline approach to guide decision making for safe sterile admixing. Often these guidelines are established and maintained at individual practicing locations with varying levels of detail and accuracy. In an effort to improve sterile compounding across a multihospital system, we developed and implemented beyond use dating guidelines to improve consistency and patient safety while meeting regulatory concerns.
| S-EPMC5030877 | biostudies-literature
Project description:BackgroundMolecular characterization has the potential to advance the management of pediatric cancer and high-risk hematologic disease. The clinical integration of genome sequencing into standard clinical practice has been limited and the potential utility of genome sequencing to identify clinically impactful information beyond targetable alterations has been underestimated.MethodsThe Precision in Pediatric Sequencing (PIPseq) Program at Columbia University Medical Center instituted prospective clinical next generation sequencing (NGS) for pediatric cancer and hematologic disorders at risk for treatment failure. We performed cancer whole exome sequencing (WES) of patient-matched tumor-normal samples and RNA sequencing (RNA-seq) of tumor to identify sequence variants, fusion transcripts, relative gene expression, and copy number variation (CNV). A directed cancer gene panel assay was used when sample adequacy was a concern. Constitutional WES of patients and parents was performed when a constitutionally encoded disease was suspected. Results were initially reviewed by a molecular pathologist and subsequently by a multi-disciplinary molecular tumor board. Clinical reports were issued to the ordering physician and posted to the patient's electronic medical record.ResultsNGS was performed on tumor and/or normal tissue from 101 high-risk pediatric patients. Potentially actionable alterations were identified in 38% of patients, of which only 16% subsequently received matched therapy. In an additional 38% of patients, the genomic data provided clinically relevant information of diagnostic, prognostic, or pharmacogenomic significance. RNA-seq was clinically impactful in 37/65 patients (57%) providing diagnostic and/or prognostic information for 17 patients (26%) and identified therapeutic targets in 15 patients (23%). Known or likely pathogenic germline alterations were discovered in 18/90 patients (20%) with 14% having germline alternations in cancer predisposition genes. American College of Medical Genetics (ACMG) secondary findings were identified in six patients.ConclusionsOur results demonstrate the feasibility of incorporating clinical NGS into pediatric hematology-oncology practice. Beyond the identification of actionable alterations, the ability to avoid ineffective/inappropriate therapies, make a definitive diagnosis, and identify pharmacogenomic modifiers is clinically impactful. Taking a more inclusive view of potential clinical utility, 66% of cases tested through our program had clinically impactful findings and samples interrogated with both WES and RNA-seq resulted in data that impacted clinical decisions in 75% of cases.
| S-EPMC5180407 | biostudies-literature
Project description:BACKGROUND/OBJECTIVES:Malnutrition is present in 20-50% of hospitalized patients, and nutritional care is a challenge. The aim was to evaluate whether the implementation of a nutritional strategy would influence nutritional care performance in a university hospital. SUBJECTS/METHODS:This was a prospective quality improvement program implementing guidelines for nutritional care, with the aim of improving nutritional practice. The Nutrition Risk Screening (NRS) 2002 was used. Point prevalence surveys over 2 years to determine whether nutritional practice had improved. RESULTS:In total, 3604 (70%) of 5183 eligible patients were screened and 1230 (34%) were at nutritional risk. Only 53% of the at-risk patients got nutritional treatment and 5% were seen by a dietician. The proportion of patients screened increased from the first to the eighth point prevalence survey (P=0.012), but not the proportion of patients treated (P=0.66). The four initial screening questions in NRS 2002 identified 92% of the patients not at nutritional risk. CONCLUSIONS:Implementation of nutritional guidelines improved the screening performance, but did not increase the proportion of patients who received nutritional treatment. Point prevalence surveys were useful to evaluate nutritional practice in this university hospital. In order to improve practice, we suggest using only the four initial screening questions in NRS 2002 to identify patients not at risk, better education in nutritional care for physicians and nurses, and more dieticians employed. Audit of implementation of guidelines, performed by health authorities, and specific reimbursement for managing nutrition may also improve practice.
| S-EPMC3303136 | biostudies-literature
Project description:Background: Extemporaneous preparations are commonly used in Indonesia, hence, Beyond-Use Date (BUD) information needs to be delivered by pharmacists to patients to maximize drug stability and enhance safety. Objective: This study aims to evaluate BUD interventions carried out by Indonesian pharmacists. Methods: A cross-sectional design was used, while a validated and reliable questionnaire was given to the samples using the snowballing and purposive sampling methods. The sample criteria were Indonesian pharmacists who had experience serving patients' extemporaneous prescriptions and those that completed the questionnaire. The significance of the relationship between BUD interventions and samples' characteristics was evaluated using the Mann-Whitney U test. Results: From the 221 total respondents, the majority admitted that they always provide BUD labeling on crushed tablets 46%, syrup 50.7%, and ointment 49.6% extemporaneous preparations. Similarly, most of the respondents also affirmed that they always provided BUD verbal information to patients on crushed tablets 66.8%, syrup 68%, and ointment 64% extemporaneous preparations. However, the remaining pharmacists, ranging from 32% to 54%, acknowledged that they did not always deliver both BUD labeling and verbal information to patients. Compared to the community-based, hospital pharmacists provided BUD labeling more frequently on all extemporaneous formulations as demonstrated by P < .05. Additionally, pharmacists found to work in Jakarta and the surrounding areas provided substantially more BUD labeling on crushed tablets and ointment (P < .05) compared to other workplace. Adult pharmacists also provided BUD labeling on crushed tablet formulations more often than the middle-aged (P < .05). Only the crushed tablet preparation was associated with the provision of BUD verbal information (P = .004). Conclusions: Based on the results, not all pharmacists verbally inform patients about BUDs nor provide drug labeling on various extemporaneous preparations. The determinant factors contributing to BUD labeling provisions were the type of practice, workplace location, and age. For the provision of verbal information, the only determinant factor was the type of practice.
| S-EPMC10977058 | biostudies-literature
Project description:Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec, which provides long-lasting basal insulin coverage, and insulin aspart, which targets postprandial glycaemia. This review provides expert opinion on the practical clinical use of IDegAsp, including: dose timings relative to meals, when and how to intensify treatment from once-daily (OD) to twice-daily (BID) dose adjustments, and use in special populations (including hospitalized patients). IDegAsp could be considered as one among the choices for initiating insulin treatment, preferential to starting on basal insulin alone, particularly for people with severe hyperglycaemia and/or when postprandial hyperglycaemia is a major concern. The recommended starting dose of IDegAsp is 10 units with the most carbohydrate-rich meal(s), followed by individualized dose adjustments. Insulin doses should be titrated once weekly in two-unit steps, guided by individualized fasting plasma glucose targets and based on patient goals, preferences and hypoglycaemia risk. Options for intensification from IDegAsp OD are discussed, which should be guided by HbA1c, prandial glucose levels, meal patterns and patient preferences. Recommendations for switching to IDegAsp from basal insulin, premixed insulins OD/BID, and basal-plus/basal-bolus regimens are discussed. IDegAsp can be co-administered with other antihyperglycaemic drugs; however, sulphonylureas frequently need to be discontinued or the dose reduced, and the IDegAsp dose may need to be decreased when sodium-glucose co-transporter-2 inhibitors or glucagon-like peptide-1 receptor agonists are added. Considerations around the initiation or continuation of IDegAsp in hospitalized individuals are discussed, as well as in those undergoing medical procedures.
| S-EPMC7689716 | biostudies-literature
Project description:Congenital heart defects (CHDs) occur in approximately 8 per 1000 live births. Improvements in detection and treatment have increased survival. Few national estimates of the healthcare costs for infants, children and adolescents with CHDs are available.We estimated hospital costs for hospitalizations using pediatric (0-20 years) hospital discharge data from the 2009 Healthcare Cost and Utilization Project Kids' Inpatient Database (KID) for hospitalizations with CHD diagnoses. Estimates were up-weighted to be nationally representative. Mean costs were compared by demographic factors and presence of critical CHDs (CCHDs).Up-weighting of the KID generated an estimated 4,461,615 pediatric hospitalizations nationwide, excluding normal newborn births. The 163,980 (3.7%) pediatric hospitalizations with CHDs accounted for approximately $5.6 billion in hospital costs, representing 15.1% of costs for all pediatric hospitalizations in 2009. Approximately 17% of CHD hospitalizations had a CCHD, but it varied by age: approximately 14% of hospitalizations of infants, 30% of hospitalizations of patients aged 1 to 10 years, and 25% of hospitalizations of patients aged 11 to 20 years. Mean costs of CHD hospitalizations were higher in infancy ($36,601) than at older ages and were higher for hospitalizations with a CCHD diagnosis ($52,899). Hospitalizations with CCHDs accounted for 26.7% of all costs for CHD hospitalizations, with hypoplastic left heart syndrome, coarctation of the aorta, and tetralogy of Fallot having the highest total costs.Hospitalizations for children with CHDs have disproportionately high hospital costs compared with other pediatric hospitalizations, and the 17% of hospitalizations with CCHD diagnoses accounted for 27% of CHD hospital costs.
| S-EPMC4422978 | biostudies-literature
Project description: Not available
| S-EPMC11919036 | biostudies-literature
Project description:Background: Modeling techniques in the field of pediatrics present unique challenges beyond traditional model limitations, and sometimes difficulties in faithfully simulating the condition's evolution over time. Objective: This study aimed to identify whether economic modeling approaches in diabetes in pediatric patients align with the recommendations of clinical practice guidelines and the latest scientific evidence. Methods: A literature review was performed in March 2023 to identify modeling-based economic evaluations in diabetes in pediatric patients. Data were extracted and synthesized from eligible studies. Clinical practice guidelines for diabetes were gathered to compare their alignment with modeling strategies. Two endocrinology specialists provided insights on the latest findings in diabetes that are not yet included in the guidelines. A multidisciplinary group of experts agreed on the relevant themes to conduct the comparative analysis: parameter informing on glycemic control, diabetic ketoacidosis/hypoglycemia, C-peptide as prognostic biomarker, metabolic memory, age at diagnosis, socioeconomic status, pediatric-specific sources of risk equations, and pediatric-specific sources of utilities/disutilities. Results: Nineteen modeling-based studies (7 de novo, 12 predesigned models) and 34 guidelines were selected. Hemoglobin A1c was the main parameter to model the glycemic control; however, guidelines recommend the usage of complementary measures (eg, time in range) which are not included in economic models. Eight models included diabetic ketoacidosis (42.1%), 16 included hypoglycemia (84.2%), 2 included C-peptide (1 of those as prognostic factor) (10.5%) and 1 included legacy effect (5.3%). Neither guidelines nor models included recent findings, such as age at diagnosis or socioeconomic status, as prognostic factors. The lack of pediatric-specific sources for risk equations and utility/disutility values were additional limitations. Discussion: Economic models designed for assessing interventions in diabetes in pediatric patients should be based on pediatric-specific data and include novel adjuvant glucose-monitoring metrics and latest evidence on prognostic factors (C-peptide, legacy effect, age at diagnosis, socioeconomic status) to provide a more faithful reflection of the disease. Conclusions: Economic models represent useful tools to inform decision making. However, further research assessing the gaps is needed to enhance evidence-based health economic modeling that best represents reality.
| S-EPMC11797704 | biostudies-literature