Anaphylaxis post-COVID-19 vaccinations in Singapore.

Introduction: Anaphylaxis was the first serious adverse event (AE) of special interest surfaced in Singapore following coronavirus disease 2019 (COVID-19) vaccination. Individuals who developed physician-diagnosed severe allergic reactions to the mRNA vaccines would be medically ineligible for mRNA vaccines and offered non-mRNA alternatives. This paper describes anaphylaxis reports received by the Health Sciences Authority (HSA) and presents a review of individuals who received heterologous COVID-19 vaccination.

National income accounting attributes and economic welfare. Evidence from Pakistan.

Economic welfare is essential in the modern economy since it directly reflects the standard of living, distribution of resources, and general social satisfaction, which influences individual and social well-being. This study aims to explore the relationship between national income accounting different attributes and the economic welfare in Pakistan. However, this study used data from 1950 to 2022, and data was downloaded from the World Bank data portal.

Red blood cell transfusion in neurocritical patients: a systematic review and meta-analysis.

Background: Anemia can lead to secondary brain damage by reducing arterial oxygen content and brain oxygen supply. Patients with acute brain injury have impaired self-regulation. Brain hypoxia may also occur even in mild anemia.

The Problems with Online Health Product Sales: How can Regulations be Improved?

With the rapid proliferation of online businesses, national authorities are facing challenges managing the online supply of illegal health products due to the anonymity of the internet, increasing number of global syndicates, new technologies, and inability to enforce against overseas sellers. This paper describes these challenges and the Health Sciences Authority's regulatory approaches to tackle the online sales of illegal health products. These include partnering with platform administrators to remove illegal online postings, leveraging technological tools and relevant legislation, empowering consumers to make informed decisions, and fostering closer collaborations across different jurisdictions to combat online pharmaceutical crimes.

An updated analysis on myocarditis and pericarditis cases reported following mRNA SARS-CoV-2 vaccination in Singapore.

Introduction: Messenger ribonucleic acid (mRNA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines have been associated with myocarditis/pericarditis, especially in young males. We evaluated the risk of myocarditis/pericarditis following mRNA vaccines by brand, age, sex and dose number in Singapore.

Methods: Adverse event reports of myocarditis/pericarditis following mRNA vaccines received by the Health Sciences Authority from 30 December 2020 to 25 July 2022 were included, with a data lock on 30 September 2022.

Nationwide safety surveillance of COVID-19 mRNA vaccines following primary series and first booster vaccination in Singapore.

Background: The real-world safety profile of COVID-19 mRNA vaccines remains incompletely elucidated.

Methods: We performed a nationwide post-market safety surveillance analysis in Singapore, on vacinees aged 5 years and older, through mid-September 2022. Observed-over-expected (O/E) analyses were performed to identify potential safety signals among eight shortlisted adverse events of special interest (AESIs): strokes, cerebral venous thrombosis (CVT), acute myocardial infarction, myocarditis/pericarditis, pulmonary embolism, immune thrombocytopenia, convulsions and appendicitis.

3D Molybdenum Disulfide Nanospheres Loaded with Metformin to Enhance SCPP Scaffolds for Bone Regeneration.

Conventional strontium-doped calcium polyphosphate (SCPP) ceramics have attracted a lot of attention due to good cytocompatibility and controlled degradation. However, their poor mechanical strength, brittleness, and difficulty in eliminating unavoidable postoperative inflammation and bacterial infections in practical applications limit their further clinical application. In this study, carboxylated molybdenum disulfide nanospheres (MoS-COOH) were first prepared via a one-step hydrothermal method.

Pericarditis and myocarditis after COVID-19 mRNA vaccination in a nationwide setting.

Introduction: Despite reports suggesting an association between COVID-19 mRNA vaccination and pericarditis and myocarditis, detailed nationwide population-based data are sparsely available. We describe the incidence of pericarditis and myocarditis by age categories and sex after COVID-19 mRNA vaccination from a nationwide mass vaccination programme in Singapore.

Methods: The incidence of adjudicated cases of pericarditis and myocarditis following COVID-19 mRNA vaccination that were reported to the vaccine safety committee between January to July 2021 was compared with the background incidence of myocarditis in Singapore.

Association between neutrophil-to-lymphocyte ratio and major postoperative complications after carotid endarterectomy: A retrospective cohort study.

Background: Carotid artery cross-clamping during carotid endarterectomy (CEA) may damage local cerebral perfusion and induce cerebral ischemia-reperfusion injury to activate local inflammatory responses. Neutrophil-to-lymphocyte ratio (NLR) is an indicator that reflects systemic inflammation. However, the correlation between NLR and complications after CEA remains unclear.

Discriminating electrocardiographic responses to His-bundle pacing using machine learning.

Background: His-bundle pacing (HBP) has emerged as an alternative to conventional ventricular pacing because of its ability to deliver physiological ventricular activation. Pacing at the His bundle produces different electrocardiographic (ECG) responses: selective His-bundle pacing (S-HBP), non-selective His bundle pacing (NS-HBP), and myocardium-only capture (MOC). These 3 capture types must be distinguished from each other, which can be challenging and time-consuming even for experts.

Feasibility of Ultra-Rapid Exome Sequencing in Critically Ill Infants and Children With Suspected Monogenic Conditions in the Australian Public Health Care System.

Importance: Widespread adoption of rapid genomic testing in pediatric critical care requires robust clinical and laboratory pathways that provide equitable and consistent service across health care systems.

Objective: To prospectively evaluate the performance of a multicenter network for ultra-rapid genomic diagnosis in a public health care system.

Design, Setting, And Participants: Descriptive feasibility study of critically ill pediatric patients with suspected monogenic conditions treated at 12 Australian hospitals between March 2018 and February 2019, with data collected to May 2019.

Usage Pattern of Carbamazepine and Associated Severe Cutaneous Adverse Reactions in Singapore Following Implementation of Genotyping as Standard-of-Care.

In April 2013, the Ministry of Health and Health Sciences Authority of Singapore jointly issued recommendations for genotyping before starting carbamazepine (CBZ) in new patients of Asian ancestry as standard of care. The Ministry of Health also approved a 75% subsidy for genotyping to all patients on subsidy at public healthcare institutions. To understand the impact of these regulatory decisions, we researched the usage patterns for CBZ and levetiracetam, the trend of Stevens-Johnson syndrome/toxic epidermal necrolysis [Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)] reports associated with antiepileptic drugs and the take-up rates of tests in Singapore.

Ecotoxicological test based on inhibition of fungal laccase activity: Application to agrochemicals and the monitoring of pesticide degradation processes.

Ecotoxicological evaluations require the use of assays with several bioindicators from different trophic levels. Only a few ecotoxicological tests using fungi have been developed, reason why, detection of adverse effects from compounds that exert fungicide action may be overlooked. This work developed a toxicity test based on the inhibition of laccase enzymatic activity in the fungus Trametes versicolor.

Quantitative data mining in signal detection: the Singapore experience.

: In Singapore, the Health Sciences Authority (HSA) reviews an average of 20,000 spontaneous adverse event (AE) reports yearly. Potential safety signals are identified manually and discussed on a weekly basis. In this study, we compared the use of four quantitative data mining (QDM) methods with weekly manual review to determine if signals of disproportionate reporting (SDRs) can improve the efficiency of manual reviews and thereby enhance drug safety signal detection.

Introduction to risk management plans in the Singapore context.

A risk management plan (RMP) contains an overview of important safety concerns associated with the use of a therapeutic product (TP) and proposed pharmacovigilance activities to monitor and manage these safety concerns in the post-approval stage. The Health Sciences Authority (HSA) of Singapore has legislated its requirements for RMPs as part of its product life cycle approach in the management of safety concerns associated with TPs. Under the Health Product (Therapeutic Products) Regulations enacted in November 2016, companies may be required to implement RMPs under the direction of HSA to help ensure that the benefits of TPs outweigh their risks.

Anaesthesia use in catheter ablation for atrial fibrillation: a systematic review and meta-analysis of observational studies.

Objectives: This meta-analysis and systematic review seeks to compare both characteristic parameters and procedural outcomes of atrial fibrillation (AF) catheter ablation in patients under general anaesthesia (GA)/deep sedation and mild/moderate sedation.

Background: Catheter ablation has become a widely applied intervention for treating symptomatic AF and arrhythmias that are refractory to medical therapy. It can be conducted through from mild sedation to GA.

Fetal diagnosis of Mowat-Wilson syndrome by whole exome sequencing.

Mowat-Wilson syndrome (MWS) is a complex genetic disorder associated with heterozygous variation in ZEB2. It is mainly characterized by moderate-to-severe intellectual disability, facial dysmorphism, epilepsy, and various malformations including Hirschsprung disease, corpus callosum anomalies, and congenital heart defects. It is rarely diagnosed prenatally and there is limited information available on the prenatal phenotype associated with MWS.

LC‑MS/MS metabolome analysis detects the changes in the lipid metabolic profiles of dMMR and pMMR cells.

The DNA mismatch repair (MMR) system plays an important role in the initiation, diagnosis and treatments of colorectal cancer (CRC). Compared to CRC patients deficient in DNA MMR (dMMR), CRC patients proficient in DNA MMR (pMMR) have higher metastasis, short survival and poor response to chemotherapy and immunotherapy. It is well‑known that a high‑fat diet can cause CRC, and lipid metabolism is closely related to the development and metastasis of CRC.

Tailoring of recommendations to reduce serious cutaneous adverse drug reactions: a pharmacogenomics approach.

The Health Sciences Authority launched a pharmacogenetics initiative in 2008 to facilitate evaluation of pharmacogenetics associations pertinent for Chinese, Malays and Indians in Singapore. The aim was to reduce the incidence and unpredictability of serious adverse drug reactions, with a focus on serious skin adverse drug reactions. This paper describes the gathering of evidence and weighing of factors that led to different genotyping recommendations for HLA-B*15:02 with carbamazepine and HLA-B*58:01 with allopurinol, despite both having strong genetic associations.

Detecting Signals of Disproportionate Reporting from Singapore's Spontaneous Adverse Event Reporting System: An Application of the Sequential Probability Ratio Test.

Introduction: The ability to detect safety concerns from spontaneous adverse drug reaction reports in a timely and efficient manner remains important in public health.

Objective: This paper explores the behaviour of the Sequential Probability Ratio Test (SPRT) and ability to detect signals of disproportionate reporting (SDRs) in the Singapore context.

Methods: We used SPRT with a combination of two hypothesised relative risks (hRRs) of 2 and 4.

A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms.

Introduction: Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures.

Objectives: This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA).

Data mining spontaneous adverse drug event reports for safety signals in Singapore - a comparison of three different disproportionality measures.

Objectives: Quantitative data mining methods can be used to identify potential signals of unexpected relationships between drug and adverse event (AE). This study aims to compare and explore the use of three data mining methods in our small spontaneous AE database.

Methods: We consider reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Gamma Poisson Shrinker (GPS) assuming two different sets of criteria: (1) ROR-1.

The Effect of Using an Electric Fan on Dyspnea in Chinese Patients With Terminal Cancer.

Background: Fan therapy is often suggested for relieving the symptom of dyspnea in patients with advanced cancer, but relevant literature among Asians is limited.

Objective: Phase 2 clinical trial to assess the clinical feasibility and outcome of using an electric fan to alleviate the symptom of dyspnea in Chinese patients with advanced cancer.

Methods: Thirty patients with advanced cancer having unresolved breathlessness were recruited from Hospice and Palliative Care Centre of Kiang Wu Hospital in Macau.

Genetic heterogeneity in Cornelia de Lange syndrome (CdLS) and CdLS-like phenotypes with observed and predicted levels of mosaicism.

Background: Cornelia de Lange syndrome (CdLS) is a multisystem disorder with distinctive facial appearance, intellectual disability and growth failure as prominent features. Most individuals with typical CdLS have de novo heterozygous loss-of-function mutations in NIPBL with mosaic individuals representing a significant proportion. Mutations in other cohesin components, SMC1A, SMC3, HDAC8 and RAD21 cause less typical CdLS.