A5061585053- Pharmaceutical Economics and Policy
- Pharmaceutical Quality and Counterfeiting
- SARS-CoV-2 and COVID-19 Research
- Drug-Induced Adverse Reactions
- Animal Virus Infections Studies
- Viral Infections and Immunology Research
- Pharmacovigilance and Adverse Drug Reactions
- Polyamine Metabolism and Applications
- Intellectual Property and Patents
- Statistical and Computational Modeling
- Diabetes and associated disorders
- Identification and Quantification in Food
- Water Treatment and Disinfection
- Inflammatory mediators and NSAID effects
- Biotechnology and Related Fields
- Pericarditis and Cardiac Tamponade
- RNA Interference and Gene Delivery
- Peptidase Inhibition and Analysis
- Pharmacological Effects and Toxicity Studies
- Allergic Rhinitis and Sensitization
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Genetic Associations and Epidemiology
- Biosimilars and Bioanalytical Methods
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical industry and healthcare
Health Sciences Authority
2011-2024
National Heart Centre Singapore
2022
Despite reports suggesting an association between COVID-19 mRNA vaccination and pericarditis myocarditis, detailed nationwide population-based data are sparsely available. We describe the incidence of myocarditis by age categories sex after from a mass programme in Singapore.The adjudicated cases following that were reported to vaccine safety committee January July 2021 was compared with background Singapore.As end 2021, total 34 (9 only, 14 11 concomitant myocarditis) 7,183,889 doses...
As of December 2017, 20 diabetic ketosis (DK)/diabetic ketoacidosis (DKA) cases associated with sodium–glucose co-transporter 2 inhibitors (SGLT2i) had been reported to the Health Sciences Authority (HSA), Singapore. We aimed provide a detailed analysis profile these cases. part emerging safety issue monitoring, HSA followed up on SGLT2i-associated DK/DKA reporters obtain missing and/or supplementary information. Descriptive statistics were employed summarise data collected, while...
The objective of this study is to collate and analyse adverse event reports associated with the use complementary health products (CHP) submitted Health Sciences Authority (HSA) Singapore for period 2010-2016 identify various trends signals pharmacovigilance purposes. A total 147,215 suspected be pharmaceutical CHP were received by HSA between 2010 2016. Of these, 143,191 (97.3%) chemical drugs, 1,807 (1.2%) vaccines, 1,324 (0.9%) biological drugs (biologics), 893 (0.6%) CHP. number Chinese...
Abstract 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 by brand, age, sex and dose number Singapore. Methods: Adverse event reports received Health Sciences Authority from 30 December 2020 to 25 July 2022 were included, a data lock on September 2022. Case adjudication was done an...
Substandard medicines are that fail to meet their quality standards and/or specifications. can lead serious safety issues affecting public health. With the increasing number of pharmaceuticals and complexity pharmaceutical manufacturing supply chain, monitoring for substandard via manual environmental scanning be laborious time consuming.A web crawler was developed automatically detect extract alerts on published Internet by regulatory agencies. The crawled data were labelled as related or...
Information on drug safety in different ethnic populations reported public documents such as the European Public Assessment Reports (EPARs), Summary of Product Characteristics (SmPCs) or Singapore Package Inserts (SGPIs) generally appears limited. This study aimed to clarify extent data that is available registration dossiers used for Union (EU) and Singapore, how much this information then included EPARs SmPCs SGPIs. For purpose, these a selection 25 drugs authorized both EU were compared...
Background: The real-world safety profile of COVID-19 mRNA vaccines remains incompletely understood. We sought to identify and validate potential signals associated with vaccines.Methods: performed a nationwide post-market surveillance analysis in vacinees aged 5 years above, up till mid-September 2022. Observed over expected (O/E) analyses were among eight shortlisted adverse events special interest (AESIs): strokes, cerebral venous thrombosis (CVT), acute myocardial infarction,...
Introduction: Despite reports suggesting an association between COVID-19 mRNA vaccination and pericarditis myocarditis, detailed nationwide population-based data are sparsely available. We describe the incidence of myocarditis by age categories sex after from a mass programme in Singapore. Methods: The adjudicated cases following that were reported to vaccine safety committee January July 2021 was compared with background All treatment discontinued 2 months. Average NAPSI score on each hand...
Background: Effective benefit–risk communication to healthcare professionals plays a vital role in promoting the rational use of medicinal products. The Health Sciences Authority (HSA) Singapore has implemented Physician Educational Materials (PEMs) and Patient Medication Guides (PMGs) as educational materials support informed decision-making. To evaluate their effectiveness safety tool, we sought understand prescribers’ experiences preferences with these materials. Methods: Invitations an...
Monitoring for substandard medicines by regulatory agencies is a key post-market surveillance activity. It important to prioritise critical product defects review ensure that prompt risk mitigation actions are taken.A impact prioritisation model (RISMED) with 11 factors considering the seriousness and extent of defect was developed. The generated an overall score categorised cases into high, medium or low impact. further developed statistical scoring (stat-RISMED) using multivariate logistic...
Anaphylaxis was the first serious adverse event of special interest following COVID-19 vaccination to have surfaced in Singapore. Characteristics reported anaphylaxis cases received through HSA’s spontaneous reporting system from 30 December 2020 31 July 2022 and results review a subset exposed heterologous are presented this paper. Most occurred females, adults persons with allergy histories, which were similarly observed for post-COVID 19 vaccinations other reports globally. The...