Administration Safety Research Articles

Stability comparison of prasugrel tablets unit‐dose packaged versus maintained in the manufacturer container over 90 days

AbstractBackgroundUnit‐dosing medications can improve time to drug administration and patient safety in inpatient settings. No available information supports the practice of unit‐dosing for prasugrel.AimThe stability of unit‐dosed prasugrel tablets was evaluated against tablets maintained in the manufacturer container.MethodThree lots of 10 mg prasugrel tablets were packaged as individual unit‐doses and stored at room temperature. Tablets were analysed for prasugrel concentration over a 90‐day period and compared against control tablets retained in the manufacturer's container. Prasugrel was quantified using a previously validated stability‐indicating high‐performance liquid chromatography method with ultraviolet detection. Experimental lots were monitored for >10% loss of potency. A non‐linear one‐phase decay curve was used to describe drug potency changes in experimental versus control tablets. Ethics approval was not required for this research article as it was a stability study and did not involve human subjects.ResultsAverage potency in all groups remained above 90% for the duration of the study; however, some individual experimental samples dropped below 90% at 7 days. Control tablets did not show a statistically significant potency change until 90 days. Modelling data indicated the ending average potencies in the experimental versus control tablets were 9.083 mg and 9.736 mg, respectively.ConclusionUnit‐dosing 10 mg prasugrel tablets has a negative effect on potency, which was most pronounced by day 7. The average potency remained above 9.00 mg over the 90‐day period. Conservative interpretation of these data may allow institutions to unit‐dose prasugrel tablets and discard after 72 h, when individual data points showed <90% potency. The decision to unit‐dose prasugrel must consider several factors surrounding patient care and individual institutional standards.

Improving Medication-Related Safety for Residents in Nursing Homes: A Qualitative Study.

To gain a better understanding of the perceptions of RNs on medication safety concerns and potential solutions for nursing home (NH) residents. This prospective, qualitative study used semi-structured phone interviews with a description approach. We used purposeful sampling to recruit 12 RNs employed at two NHs in the northeastern region of the United States. The Systems Engineering Initiative for Patient Safety constructs informed the interview guide, coding, and qualitative theme identification. We categorized non-user-friendly charting systems and gained insights into more experience with paper-based charting under the technology component. For the organization component, participants identified the importance of teamwork, communication, and leadership. Participants also mentioned how education and nationality of training impact medication administration (MA) safety. Task-related concerns revealed how different care approaches, extreme workload variation, and task prioritization during the day are perceived as critical issues that need to be addressed. Staff shortages were also expressed as an environment-related concern. Findings highlight the importance of appropriate nurse-to-patient ratio, the significance of user-friendly charting systems, and customizing the interface of MA in the charting system. [Journal of Gerontological Nursing, xx(xx), xx-xx.].

THE LOCAL GOVERNMENT UNITS ALONG THE COASTAL STRIP OF THE REPUBLIC OF POLAND: IMPLEMENTATION POLICY REGARDING THEIR AUTONOMOUS TASKS IN THE FIELD OF HEALTHCARE. SELECTED SEASONAL SAFETY ISSUES

The study assesses the challenges of health care and emergency medical services in tourist areas such as the Baltic coastal strip, focusing on public administration and citizen safety. The study analysed local government at the level of municipalities (in the Mielno municipality), counties (Koszalin county) and provinces (Zachodniopomorskie voivodeship), looking at health care and emergency medical services based on their geographical and social differences. The study asked whether these differences between the three levels of local government in Poland are due to their specific roles in the area and whether seasonal changes affect their increased commitment to tasks. It explored which aspects of health care present the greatest challenges in this context. The study has a national dimension. Methodology adapted to public administration research, using a comparative method, descriptive analysis and document analysis. The process took place in three stages: formulation of the research hypothesis (H1 = Polish coastal municipalities face additional safety and health tasks), selection of research tools, data collection and organisation, and operationalisation of data. The study confirmed the hypothesis, confirming that local governments in coastal areas take on additional safety and health responsibilities in Poland. The results of the study confirm hypothesis H1 at the level of Polish municipalities, indicating significant challenges in these areas. However, in the West Pomeranian Voivodeship and Koszalin County, these relationships are relatively less pronounced compared to the country. The thorough approach and methodology of the study confirm the increased responsibility of coastal municipalities in terms of health care and safety measures, shedding light on the complexity encountered in these regions.

Acoustic Radiation Force Optical Coherence Elastography of the Crystalline Lens: Safety.

To assess the safety of acoustic radiation force optical coherence elastography in the crystalline lens in situ. Acoustic radiation force (ARF) produced by an immersion single-element ultrasound transducer (nominal frequency = 3.5 MHz) was characterized using a needle hydrophone and used for optical coherence elastography (OCE) of the crystalline lens. Preamplified signals at 50, 100, 250, 500, 750, 1000, and 1250 mV peak amplitude were tested on ex vivo porcine eyes (n = 21). Three-dimensional optical coherence tomography (OCT) and confocal microscopy images were acquired before and after ARF exposure to each signal amplitude to determine damage. The acoustic intensity of the ultrasound transducer at 100-mV preamplified peak amplitude input demonstrated a signal-to-noise ratio high enough for tracking elastic wave propagation in the lens and spatial-peak pulse-average (SPPA) intensity of 24.1 W/cm² and mechanical index (MI) of 0.46. The SPPA intensity was lower than the U.S. Food and Drug Administration (FDA) safety limit (28 W/cm2), but the MI was twice the safety limit (0.23). OCT structural and confocal microscopy images showed damage only at levels exceeding 1150 W/cm2 and 3.2 for SPPA intensity and MI, respectively. OCT and confocal microscopy showed that, even when the intensity exceeded FDA recommendations (>100 mV), no noticeable damage was observed. Although a further reduction in acoustic intensity is necessary to meet FDA safety limits, ARF-based elastography shows promise for safe clinical translation in quantitatively characterizing lenticular biomechanical properties. This work assessed the safety standards for acoustic radiation force to be used in human lens elastography according to the FDA safety limits.

Drug Administration Errors Between Anesthetists: The Burden in Libya

Safe medication preparation and administration is a key part of anaesthesia practice. While anaesthesia practice has become safer, some medication errors can be inevitable leading to devastating complications. There is limited data and research on anaesthesia medication errors in developing economies. This study aims to identify the occurrence of medication errors and examines the associated factors, incident reporting, and preventive measures taken by anaesthetist practitioners in Libya. This was a multicentre; cross-sectional survey study conducted at three tertiary teaching hospitals in Libya from January 1, 2023 to June 30, 2023. An online questionnaire was sent to potential participants. Data was analysed using Statistical Package for Social Science (SPSS). The findings are expressed as absolute numbers and percentages. 185 completed surveys were returned for analysis (response rate = 84.09%). Anaesthesia technician (90.8%) commonly does medication preparation. 37.8% of respondents experienced one medication error and did not cause any harm to patients. Heavy workload/long hours (18.4%) were identified as the most common contributor to medication error in the operating room. Nearly all respondents 151 (81.6%) strongly agreed that double-checking the medication before administration was the most crucial preventive measure against medication errors. No effective reporting systems were identified. The study results are valuable to implementing and disseminating potential medication error risk mitigation or preventive strategies in developing economies. Enhancing medication administration safety in clinical practice should be a priority for policymakers at local and national levels across all healthcare contexts.

Evaluation of Door-to-Needle Times Between Alteplase and Tenecteplase for Acute Ischemic Stroke at Two Academic Medical Centers.

Off-label tenecteplase use for acute ischemic stroke (AIS) has increased due to ease of administration and comparable efficacy and safety to alteplase. This study aimed to evaluate time to thrombolysis before and after transition from alteplase to tenecteplase for treatment of AIS at 2 institutions. This retrospective cohort study included adult patients receiving thrombolysis for AIS before and after transition from alteplase to tenecteplase at 2 academic medical centers from January 1, 2020 to January 31, 2024. The primary endpoint was door-to-needle (DTN) time, defined as minutes from hospital arrival to thrombolysis administration. Notable secondary endpoints included time from last known well (LKW) to thrombolysis, time from brain imaging to thrombolysis, hospital length of stay (LOS), and incidence of symptomatic intracranial hemorrhage (sICH). A total of 328 patients (168 tenecteplase and 160 alteplase) were included. Patients were 51.5% female with a median (interquartile range [IQR]) age of 70 [58-80] years and initial National Institutes of Health Stroke Scale (NIHSS) score of 8 [5-14]. There was no statistically significant difference in DTN time (60 vs 56 minutes), time from LKW to thrombolysis (134 vs 147.5 minutes), or time from brain imaging to thrombolysis (32 vs 31 minutes) between tenecteplase and alteplase. Hospital LOS (5.7 vs 4.9 days) and the rates of sICH (3% vs 3.8%) were similar between groups. Tenecteplase and alteplase had comparable DTN times for treatment of AIS and similar safety endpoints. Further studies are warranted to identify opportunities to streamline DTN times with tenecteplase.

Expanding on Methodologies for Analyzing Truck Speeds in States with Differential Speed Limits

The Federal Motor Carrier Safety Administration (FMCSA) and National Highway Traffic Safety Administration (NHTSA) reported that in 2020, 7.3% of large truck driver fatalities had speed as a contributing factor. Several states have implemented truck differential speed limits (DSLs) with the objective of improving safety. This study compares truck speeds in 16 states, 8 of which have implemented DSLs (Arkansas, California, Idaho, Indiana, Michigan, Montana, Oregon, and Washington) and 8 of which have not (Illinois, Kentucky, Minnesota, Oklahoma, South Dakota, Tennessee, Wisconsin, and Wyoming). The DSLs ranged from 55 MPH in California (CA) to 70 MPH in Montana (MT). Over 240,000 speed samples from connected trucks were analyzed during a one-week period from 15–22 April 2024. The 50th percentile truck speeds ranged from 60 MPH in Oregon to 69 MPH in Wyoming. The 85th percentile truck speeds ranged from 65 MPH in Washington, Oregon, and California to 74 MPH in Wyoming. The 85th percentile speeds across all segments were greater than the posted truck speed limit in 90% of segments with DSLs, but only 12.5% of segments without DSLs. The average interquartile range (IQR) of truck speeds for the eight states with DSLs was 19% smaller than the average IQR of the eight states without DSLs. The methodologies and visuals presented by this study are easily scalable to any route and location provided the availability of a representative connected truck dataset.

Bibliometric analysis of the usage of tenecteplase for stroke

IntroductionIn recent years, tenecteplase has been competing with alteplase as a treatment for acute ischemic stroke given its ease of administration, lower dosage, cost-effectiveness, and better safety data. This paper seeks to analyze academic literature regarding the burgeoning usage of tenecteplase as a treatment for acute ischemic stroke across the world.MethodThe Web of Science database was used to collect the data from articles containing the keywords “Tenecteplase” and “Stroke” published from 1999 to 2023. The search resulted in 576 journal articles. This study analyzed metadata related to the country, institution, keywords, and date published for each article in the database pertaining to tenecteplase use for stroke.ResultsThe United States led in publications (260, 39.93%), followed by Australia (101, 15.51%), and a tie for third place between Canada and China (77, 11.83% each). The three most prevalent keywords were tenecteplase (N = 324), alteplase (N = 284), and thrombolysis (N = 244). The University of Melbourne and the University of Calgary were the leading institutions publishing on the use of tenecteplase as a treatment for stroke. In 2023, the number of publications on the usage of tenecteplase for stroke was the greatest, making up 24.3% of all papers on the topic.ConclusionThe surge in academic papers regarding tenecteplase in stroke in 2023 could be a good indicator of the drug’s increasing prevalence as a treatment for stroke. Despite this finding, tenecteplase is currently not an FDA-approved therapy in the US as Genentech, the drug’s manufacturer, has yet to file for federal approval for acute ischemic stroke treatment.

The Intra-Meatal Application of Tadalafil Cream Versus Oral Administration Efficacy and Safety: Results from a Randomized, Two-Administration Route, Cross-Over Clinical Trial.

Background: Tadalafil cream, a topically administered phosphodiesterase-5 inhibitor (PDE5), presents a potential alternative to oral PDE5 inhibitors like tadalafil for the treatment of erectile dysfunction (ED). This study evaluates the non-inferiority and potential superiority of tadalafil cream compared to oral tadalafil. Methods: This randomized controlled trial employed a cross-over design with two treatment periods of two weeks each, separated by a one-week washout phase. Thirty-five male participants aged 18-75 with diagnosed ED (International Index of Erectile Function-Erectile function: IIEF-EF score < 26) were randomized to receive either tadalafil cream or oral tadalafil. Tadalafil cream was applied topically, while tadalafil was taken orally. The primary endpoint was IIEF-EF, and secondary endpoints were measured using the International Index of Erectile Function (IIEF) domain scores. Adverse events and treatment preferences were also assessed. Results: Tadalafil cream showed a higher increase in sexual function across all IIEF domains compared to oral tadalafil. The lower bounds of the confidence interval [improvement: final-baseline scores between tadalafil cream and oral tadalafil 0.72 (95% CI -2.72-4.15)] were above the non-inferiority margin of -3.22, confirming tadalafil cream's non-inferiority in the erectile function domain. In the intercourse satisfaction domain, tadalafil cream was superior to oral tadalafil. At the end of the trial, 88.57% of participants preferred tadalafil cream (95% CI 73.26%-96.79%), a result significantly above the non-inferiority margin that indicated superiority (p < 0.001). No systemic adverse events were reported for tadalafil cream, and significant differences in dizziness, headache, nasal congestion, and erythema were observed between the two treatments. Conclusions: Tadalafil cream is a safe and effective treatment for erectile dysfunction, demonstrating non-inferiority and potential superiority over oral tadalafil, with a high patient preference. Its topical administration offers a promising alternative for patients, particularly those with cardiovascular diseases where oral PDE5 inhibitors are contraindicated or less well tolerated.

IMPACT OF REAL-LIFE ENVIRONMENTAL EXPOSURES ON REPRODUCTION: A contemporary review of machine learning to predict adverse pregnancy outcomes from pharmaceuticals, including DDIs.

Clinical drug trials often do not include pregnant people due to health risks; therefore, many medications have an unknown effect on the developing fetus. Machine learning QSAR models have been used successfully to predict the fetal risk of pharmaceutical use during pregnancy. Those undergoing pregnancy are often excluded from clinical drug trials due to the risk that participation would pose to their health and the health of the developing fetus. However, they often require pharmaceuticals to manage health conditions that, if left untreated, could harm themselves or the fetus. This can mean that such individuals take one or more pharmaceuticals during pregnancy, many of which have unknown reproductive effects. Machine learning models have been used to successfully predict a number of reproductive toxicological outcomes for pharmaceuticals, including transplacental transfer, US Food and Drug Administration safety rating, and drug interactions. Models use quantitative chemical and structural features of active compounds as inputs to make predictions concerning the outcome of interest using computational algorithms. Models are validated and evaluated rigorously with metrics such as accuracy, area under the receiver operator curve, sensitivity, and precision. Results from these models can be a potential source of valuable information for pregnant people and their medical providers when making decisions regarding therapeutic drug use. This review summarizes current machine learning applications to make predictions about the risk and toxicity of medication use during pregnancy. Our review of the recent literature revealed that machine learning quantitative structure-activity relationship models can be used successfully to predict the transplacental transfer and the US Food and Drug Administration pregnancy safety category of pharmaceuticals; such models have also been employed to predict drug interactions, though not specifically during pregnancy. This latter topic is a potential area for future research. In this review, no single algorithm or descriptor-calculation software emerged as the most widely used, and their performances depend on a variety of factors, including the outcome of interest and combination of such algorithms and software.

Transforming the electronic health record from a documentation application to an automated diet program for personalizing neonatal nutrition and improving feeding administration safety through process improvement.

Delivering adequate nutrition to preterm and sick neonates is critical for growth. Infants in the neonatal intensive care unit (NICU) require additional calories to supplement feedings for higher metabolic demands. Traditionally, clinicians enter free-text diet orders for a milk technician to formulate recipes, and dietitians manually calculate nutrition components to monitor growth. This daily process is complex and labor intensive with potential for error. Our goal was to develop an electronic health record (EHR)-integrated solution for entering feeding orders with automated nutrition calculations and mixing instructions. The EHR-integrated automated diet program (ADP) was created and implemented at a 52-bed level III academic NICU. The configuration of the parenteral nutrition orderable item within the EHR was adapted to generate personalized milk mixing recipes. Caloric, macronutrient, and micronutrient constituents were automatically calculated and displayed. To enhance administration safety, handwritten milk bottle patient labels were substituted with electronically generated and scannable patient labels. The program was further enhanced by calculating fortifier powder displacement factors to improve mixing precision. Order entry was optimized to allow for more complex mixing recipes and include a preference list of frequently ordered feeds. The EHR-ADP's safeguarded features allowed for catching multiple near-missed feeding administration errors. The NICU preterm neonate cohort had an average of 6-day decrease (P = 0.01) in the length of stay after implementation while maintaining the same weight gain velocity. The EHR-ADP may improve safety and efficiency; further improvements and wider utilization are needed to demonstrate the growth benefits of personalized nutrition.

A Multi-Institutional, Retrospective, Observational Study on Administration Status and Safety of In-Hospital Oral Selenium Preparation in Pediatric Patients Predominantly Suffering from Gastrointestinal Disease.

Selenium deficiency in patients with gastrointestinal diseases treated with long-term central venous nutrition is a clinical problem. Only injectable selenium is approved in Japan, and oral selenium preparations are prepared in hospitals from reagents, but their efficacy and safety are unknown. We conducted a retrospective study investigating the relationship between selenium administration and oral selenium formulations and adverse events. In this study, 239 selenium-treated cases and 220 selenium-untreated cases adjusted for patient background were selected as a reference group. The median (interquartile range, IQR) age was 1.3 (0.4-4.4) and 1.3 (0.3-4.5) years, respectively; gastrointestinal diseases were most common in 110 (46.0%) and 104 (47.3%) cases. The median (IQR) duration of treatment or observation with oral selenium was 446 (128-1157) and 414 (141-1064) days, respectively. The median (IQR) dose per body weight at the maintenance dose was 2.6 (1.7-3.9) μg/kg, and the median (IQR) serum selenium concentration at the maintenance dose was 8.5 (7.0-10.6) μg/mL within the upper tolerated dose limit and approximately the reference range. There was no difference in selenium dose, serum selenium concentration, or serum-selenium-concentration-to-dose ratio (C/D ratio) for adverse events. The incidence of adverse events was compared with that of patients not treated with selenium. An oral selenium preparation administered below the upper tolerated dose limit can be used effectively and safely in pediatric patients.

Addressing Medication Administration Safety Through Simulation: A Quasi-Experimental Study Among Nursing Students.

Healthcare institutions are dedicated to minimizing medication errors and promoting their reporting. This study investigates the impact of simulation on nursing students' attitudes toward and intention to report medication errors. A quasi-experimental one-group pre-post-test study was conducted. Third-year nursing students (N = 63) participated in a scenario-based simulation for medication administration. Participants' errors were documented. Participants self-reported attitudes toward medication administration safety and intention to report errors. The most reported error was "contraindicated in disease" (61%). The simulation increased attitudes of preparedness by the training program received (p < 0.01) and belief in the patient's involvement in preventing errors (p < 0.01), and decreased the belief that professional incompetence reveals errors (p = 0.015). Intention to report errors was influenced by medication error training received (p = 0.045), confidence in error reporting (p < 0.001), and a sense of responsibility to disclose errors (p = 0.001). Simulation effectively shapes attitudes and intentions regarding medication error reporting. Improving nursing students' awareness, skills, and clinical judgment can foster a safety culture and potentially reduce patient harm. Future research should examine the long-term effects of simulation and its impact on reducing medication errors.

Data quality and timeliness analysis for post-vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform.

This study is part of the U.S. Food and Drug Administration (FDA)'s Biologics Effectiveness and Safety (BEST) initiative, which aims to improve the FDA's postmarket surveillance capabilities by using real-world data (RWD). In the United States, using RWD for postmarket surveillance has been hindered by the inability to exchange clinical data between healthcare providers and public health organizations in an interoperable format. However, the Office of the National Coordinator for Health Information Technology (ONC) has recently enacted regulation requiring all healthcare providers to support seamless access, exchange, and use of electronic health information through the interoperable HL7 Fast Healthcare Interoperability Resources (FHIR) standard. To leverage the recent ONC changes, BEST designed a pilot platform to query and receive the clinical information necessary to analyze suspected AEs. This study assessed the feasibility of using the RWD received through the data exchange of FHIR resources to study post-vaccination AE cases by evaluating the data volume, query response time, and data quality. The study used RWD from 283 post-vaccination AE cases, which were received through the platform. We used descriptive statistics to report results and apply 322 data quality tests based on a data quality framework for EHR. The volume analysis indicated the average clinical resources for a post-vaccination AE case was 983.9 for the median partner. The query response time analysis indicated that cases could be received by the platform at a median of 3 min and 30 s. The quality analysis indicated that most of the data elements and conformance requirements useful for postmarket surveillance were met. This study describes the platform's data volume, data query response time, and data quality results from the queried postvaccination adverse event cases and identified updates to current standards to close data quality gaps.

Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology: ASCO-ONS Standards.

To update the American Society of Clinical Oncology (ASCO)-Oncology Nursing Society (ONS) standards for antineoplastic therapy administration safety in adult and pediatric oncology and highlight current standards for antineoplastic therapy for adult and pediatric populations with various routes of administration and location. ASCO and ONS convened a multidisciplinary Expert Panel with representation of multiple organizations to conduct literature reviews and add to the standards as needed. The evidence base was combined with the opinion of the ASCO-ONS Expert Panel to develop antineoplastic safety standards and guidance. Public comments were solicited and considered in preparation of the final manuscript. The standards presented here include clarification and expansion of existing standards to include home administration and other changes in processes of ordering, preparing, and administering antineoplastic therapy; the advent of immune effector cellular therapy; the importance of social determinants of health; fertility preservation; and pregnancy avoidance. In addition, the standards have added a fourth verification. Standards are provided for which health care organizations and those involved in all aspects of patient care can safely deliver antineoplastic therapy, increase the quality of care, and reduce medical errors.

The place of metformin in the treatment of carbohydrate metabolism disorders and insulin resistance during, before and after pregnancy: resolution of the expert council

Due to its effect on insulin resistance, ease of administration and favorable safety profile, metformin has been included in the recommendations of foreign medical communities for the management of pregnant women with hyperglycemia since 2008. However, in Russia, the use of any oral hypoglycemic agents during pregnancy is still contraindicated. However, recent studies demonstrate the safety and positive effects of metformin on pregnancy in patients with pregestational diabetes mellitus, polycystic ovary syndrome and gestational diabetes mellitus. In 2023, the Federal Service for Surveillance in Healthcare of the Ministry of Health of Russia updated the instructions for the medical use of Glucophage® and Glucophage®Long: pregnancy was excluded from the “Contraindications” section and moved to the “With caution” section. This resolution is intended to evaluate studies of the effectiveness and safety of metformin, as well as to study the experience of foreign colleagues and Russian legal aspects of prescribing metformin in the stages of preparation for pregnancy, during it and in the post-gravid period.

A Case of Esophagogastric Junction Cancer Treated with Pain Control by Administering Methadone Tablets Through a Gastrostomy.

Introduction: Methadone is used to treat intractable cancer pain when other opioid analgesics are ineffective. Methadone tablets may be difficult to administer in cases of gastrointestinal passage obstruction. However, changing the route of methadone tablet administration is possible. Case Description: The patient, diagnosed with esophagogastric junction cancer with multiple metastases, continued to receive methadone tablets even after not being longer able to take oral medication. Method: Methadone tablets were administered using a simple suspension method via gastrostomy. We measured the respiratory rate during sleep daily. We also measured weekly QTc values using a 12-lead electrocardiogram and methadone blood concentration periodically. No side effects were observed. Conclusion: Using a simple suspension method to administer methadone is a safe pain management method when accompanied by careful monitoring. To date, no study has examined the tube administration safety of methadone tablets. Thus, this case report is of important clinical significance.

A novel drive-through approach to vaccination of children and young people with neurodevelopmental disability.

Disparities in preventative health care likely contribute to comorbidities associated with neurodevelopmental disability. These comorbidities are risk factors for poor outcomes of COVID-19, making COVID-19 vaccination a priority for this population. In mid-2021, the Australian Technical Advisory Group (ATAGI) recommended the COVID-19 vaccination rollout include children and young people at risk of severe COVID-19 associated disease. This cohort included children/young people severely immunocompromised, with disability, and/or complex, multiple health conditions. Children and young people with neurodevelopmental disability can be challenging to vaccinate in conventional clinic environments and may experience exacerbation of behaviours posing barriers to vaccination. Remaining unvaccinated for COVID-19 increased risk of secondary complications and affected access to carers and respite facilities. This paper describes a novel, individualised approach to safe vaccination for this cohort. In consultation with stakeholders, a drive-through clinic vaccination model was developed and implemented for children/young people with neurodevelopmental disability. The model prioritised person-centred care and minimised triggering factors experienced in community clinics. Data were collected on successfully administered vaccine doses; administration safety and adverse events following immunisation. Parents/carers and staff provided reflective feedback. Twenty-four children and young people used the model with successful vaccination rate of 96% (n = 23). Most patients received multiple doses through the clinic (n = 16). Some patients were vaccinated after unsuccessful attempts elsewhere. Feedback from carers and staff was positive and no adverse events were reported. This model is generalisable to other health services and may be applied to other vaccinations for people of all ages with neurodevelopmental disabilities.

Perspectives on technology: urethral slings in a post-mesh world.

To detail the history of synthetic mid-urethral slings (SMUSs) and fascial slings, their efficacy, associated complications, and changes to practice that have occurred after the issuing of the 2011 US Food and Drug Administration (FDA) Safety Communication statement on transvaginal mesh (TVM), and to highlight the need for surgical registries and high-quality randomised controlled data to guide recommendations for continence procedures, in view of current concerns regarding mesh. A literature search was conducted in EMBASE, PubMed, and the Cochrane Database of systematic reviews to identify articles published from 2011 onward, following the FDA Safety Communication regarding TVM. Prior to the formal FDA Safety Communication in 2011, TVM was considered a safe option for the treatment of both pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The 2011 FDA safety communications and ensuing widely publicised litigation against TVM manufacturers have shifted both surgeon and patient acceptance of mesh products. Several efforts by medical and government bodies have been made to establish ways to monitor the surgical outcomes and safety of mesh products. The Australasian Pelvic Floor Procedure Registry is one such example. Although SMUSs have a long and established safety profile, perceptions of mesh products for SUI have also been negatively affected. The extent of this, however, has yet to be adequately measured through qualitative and quantitative data. The available data suggest it has been difficult for patients and consumers to distinguish between TVM morbidity for POP vs SUI. Furthermore, there remains a lack of high-quality randomised or real-world registry data to definitively exclude the SMUS from the SUI treatment algorithm. Since SMUSs are a viable option for SUI treatment, the concept of a 'post-mesh world' remains contentious. Controversies surrounding SMUSs have changed the treatment landscape of SUI. Against the background of significant litigious action following the FDA warnings against mesh use, there has been significant reduction in the uptake of synthetic mesh products. Although there are ample data related to surgical outcomes and safety for both autologous fascial and retropubic SMUSs in carefully selected patients, informed consent and surgical training will be of paramount importance as newer synthetic materials reach clinical maturity.

Fifteen-Year Trend in Inferior Vena Cava Filter Utilization before and after U.S. Food and Drug Administration Communications: Data from the National Inpatient Sample 2005–2019

The purpose of this study was to evaluate the contemporary trends in inferior vena cava (IVC) filter utilization in the inpatient setting following the U.S. Food and Drug Administration (FDA) safety communications and compare those trends in relation to incidence of hospital admissions involving venous thromboembolism (VTE). The National Inpatient Sample was queried between 2005 and 2019. There was an increasing trend in the utilization of IVC filters between 2005 and 2010 (P < .01). Following the FDA communication in 2010, this reversed to a decreasing trend (P < .001), which persisted following the second FDA communication in 2014, although there was no significant change in the rate of decline (P = .67). Throughout the study period, the proportion of IVC filters placed in patients with VTE increased from 70.8% to 82.2%.