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Implementation Aspects of a Medicines Shortage Policy Tool: Evidence from Australia's Serious Scarcity Substitution Instruments
Implementation Aspects of a Medicines Shortage Policy Tool: Evidence from Australia's Serious Scarcity Substitution Instruments
Medication shortages are a considerable and ongoing issue in healthcare, disrupting consumer access to medicines....
Enhancing Disease Surveillance and Pharmacovigilance Practices for RTS,S/AS01 Malaria Vaccine Rollout in Ghana, Kenya, and Malawi: Strategies, Impact, Challenges, and Lessons Learned
Enhancing Disease Surveillance and Pharmacovigilance Practices for RTS,S/AS01 Malaria Vaccine Rollout in Ghana, Kenya, and Malawi: Strategies, Impact, Challenges, and Lessons Learned
The rollout of new vaccines in low- and middle-income countries often faces significant challenges due to underdeveloped d...
Safety and Management of Targeted Therapies for Relapsed/Refractory Chronic Lymphocytic Leukemia
Safety and Management of Targeted Therapies for Relapsed/Refractory Chronic Lymphocytic Leukemia
Targeted therapies have transformed the treatment landscape for patients with chronic lymphocytic leukemia (CLL). These th...
Augmenting Medical Judgment in Signal Confirmation: Design Considerations for an AI-Enabled Causality Assessment Framework
Augmenting Medical Judgment in Signal Confirmation: Design Considerations for an AI-Enabled Causality Assessment Framework
The safety signal assessment process evaluates the potential causal association between a medicinal product and a specific...
Ponatinib Safety Profile: An Analysis of 10 Years of Real-World Experience
Ponatinib Safety Profile: An Analysis of 10 Years of Real-World Experience
Ponatinib is a third-generation BCR::ABL1 tyrosine kinase inhibitor indicated for the treatment of chronic myeloid leukemi...
Presence of Benzodiazepines in Aquatic Environments: A Systematic Review of the Literature
Presence of Benzodiazepines in Aquatic Environments: A Systematic Review of the Literature
Pharmaceuticals in aquatic environments are a growing environmental concern. Because of their widespread use and poor remo...
Challenges and Opportunities for Signal Detection During Public Health Emergencies: An Historical Re-evaluation of the Disproportionality Analysis of the ADR Reporting of Anti-COVID-19 Monoclonal Antibodies in Vigibase
Challenges and Opportunities for Signal Detection During Public Health Emergencies: An Historical Re-evaluation of the Disproportionality Analysis of the ADR Reporting of Anti-COVID-19 Monoclonal Antibodies in Vigibase
Anti-spike monoclonal antibodies (mAbs) for early treatment of COVID-19 represented a significant improvement in the pharm...
Transient Oral Corticosteroid Use and Acute Upper Gastrointestinal Bleeding in Mild-to-Moderate Asthma: A Case-Crossover Study
Transient Oral Corticosteroid Use and Acute Upper Gastrointestinal Bleeding in Mild-to-Moderate Asthma: A Case-Crossover Study
Sustained exposure to oral corticosteroids (OCS) increases the risk of upper gastrointestinal bleeding (UGIB). It is uncer...
Incident Neutropenia in New Users of Different Non-opioid Analgesics: An Observational Propensity Score-Controlled Cohort Study
Incident Neutropenia in New Users of Different Non-opioid Analgesics: An Observational Propensity Score-Controlled Cohort Study
Nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol have been associated with neutropenia and agranulocytosis wi...
AS01-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine (Adjuvanted RSVPreF3): Review of the First 2 Years of Post-Marketing Safety Surveillance
AS01-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine (Adjuvanted RSVPreF3): Review of the First 2 Years of Post-Marketing Safety Surveillance
The AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (adjuvanted RSVPreF3) received its first mark...
Optimising Pharmacovigilance Efficiency with MLIT (Machine Learning for Intelligent Triage): A Tool for Statistical Safety Alerts
Optimising Pharmacovigilance Efficiency with MLIT (Machine Learning for Intelligent Triage): A Tool for Statistical Safety Alerts
Pharmacovigilance is essential to ensuring patient safety by enabling timely identification of adverse reactions in increa...
Phloroglucinol Exposure During Early Pregnancy and Risk of Major Congenital Malformations: A Nationwide Cohort Study in France
Phloroglucinol Exposure During Early Pregnancy and Risk of Major Congenital Malformations: A Nationwide Cohort Study in France
Phloroglucinol is a spasmolytic drug widely prescribed in France for gastrointestinal or pelvic pain, and frequently used ...
When does Follow-up on Adverse Events Improve the Understanding of Medicine and Vaccine Safety? Insights from Global Expert Perspectives
When does Follow-up on Adverse Events Improve the Understanding of Medicine and Vaccine Safety? Insights from Global Expert Perspectives
Adverse events (AEs) reported with medicines and vaccines form the foundation of pharmacovigilance (PV), enabling the dete...
Harmonising Pharmacovigilance and Pharmacoepidemiology: Lessons from Europe for Cohesive Medicines Safety Science
Harmonising Pharmacovigilance and Pharmacoepidemiology: Lessons from Europe for Cohesive Medicines Safety Science
Historically, PE’s first major inflection point was its move from academic inquiry to regulatory science, particularly thr...
Antiemetic Combination Use During the First Trimester and Adverse Circulatory Outcomes in Newborn Infants: A Data-Mining Analysis
Antiemetic Combination Use During the First Trimester and Adverse Circulatory Outcomes in Newborn Infants: A Data-Mining Analysis
Pregnant women sometimes need antiemetic combination therapy to control severe nausea and vomiting during pregnancy. Becau...
Artificial Intelligence in Pharmacovigilance: Guiding Principles from the CIOMS Working Group XIV
Artificial Intelligence in Pharmacovigilance: Guiding Principles from the CIOMS Working Group XIV
Artificial intelligence (AI) is increasingly being explored to support pharmacovigilance activities including processes in...
Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions
Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions
Post-authorization studies (PAS) are often mandated by regulatory authorities as a condition of marketing authorization of...
Incretin-Based Drugs and the Risk of Dementia Among Patients with Type 2 Diabetes
Incretin-Based Drugs and the Risk of Dementia Among Patients with Type 2 Diabetes
Incretin-based drugs, namely glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and dipeptidyl peptidase 4 (DPP-4) inhi...
Strengthening Signal Detection in Pharmacovigilance by Using International Nonproprietary Name (INN) Stems
Strengthening Signal Detection in Pharmacovigilance by Using International Nonproprietary Name (INN) Stems
‘Stems’, which mark pharmacological relationships between substances, form the backbone of the International N...
Sexual Dysfunctions Associated with Proton Pump Inhibitors: Insights from VigiBase, the World Health Organization Pharmacovigilance Database
Sexual Dysfunctions Associated with Proton Pump Inhibitors: Insights from VigiBase, the World Health Organization Pharmacovigilance Database
Over the years, several observational studies and case reports have been published hypothesizing a potential association b...
A National Response to Warfarin Shortages: Evaluating Regulatory Substitution and Notified Shortages and Their Effects on Antithrombotic Dispensings, Pathology Monitoring and Adverse Event Trends in Australia
A National Response to Warfarin Shortages: Evaluating Regulatory Substitution and Notified Shortages and Their Effects on Antithrombotic Dispensings, Pathology Monitoring and Adverse Event Trends in Australia
Medicine shortages are an increasing threat to medicine safety and access. In Australia, a 7-month shortage of Coumadin 5-...
Medications Associated with Increased Risk of Hypoglycemia in Older Adults on Sulfonylureas: A High-Throughput Case-Crossover-Based Screening Study
Medications Associated with Increased Risk of Hypoglycemia in Older Adults on Sulfonylureas: A High-Throughput Case-Crossover-Based Screening Study
Sulfonylureas (SU) are widely used for diabetes management in older adults but can cause hypoglycemia, which may be worsen...
Systematic Review of Active Safety Surveillance of Vaccines and Medicines in Low- and Middle-Income Countries
Systematic Review of Active Safety Surveillance of Vaccines and Medicines in Low- and Middle-Income Countries
Functional active safety surveillance is essential for post-authorization assessment and life-cycle safety evidence genera...
Hepatic Effects, Potential Drug-Induced Liver Injury, and Other Liver Safety Considerations of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in the New Era of Expanding Non-oncology Indications: Literature Review and Expert Consensus
Hepatic Effects, Potential Drug-Induced Liver Injury, and Other Liver Safety Considerations of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in the New Era of Expanding Non-oncology Indications: Literature Review and Expert Consensus
Chimeric antigen receptor T-cell (CAR-T) therapy is a rapidly expanding key therapeutic category, originally pioneered for...
Unsuspected Adverse Drug Reactions to Dermatologic Medications: An Epidemiological Hypothesis-Free Screening Study of Real-World Data in Denmark
Unsuspected Adverse Drug Reactions to Dermatologic Medications: An Epidemiological Hypothesis-Free Screening Study of Real-World Data in Denmark
Many adverse drug reactions (ADRs) to dermatological drugs may be underrecognized due to limitations in traditional survei...
MCSG: A Method for Simultaneous Disproportionality Analysis and Background Rate Estimation in Large Pharmacovigilance Databases
MCSG: A Method for Simultaneous Disproportionality Analysis and Background Rate Estimation in Large Pharmacovigilance Databases
Databases for safety monitoring of medicinal products contain records of a huge number of pairings of drugs and adverse ev...
Narrative Search Engine for Case Series Assessment Supported by Artificial Intelligence Query Suggestions
Narrative Search Engine for Case Series Assessment Supported by Artificial Intelligence Query Suggestions
Manual identification of case narratives with specific relevant information can be challenging when working with large num...
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ
The life expectancy of patients with schizophrenia is reduced, partly due to cardiovascular diseases. Antipsychotics are a...
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients
Chimeric antigen receptor T-cell (CAR-T) therapies are one of the main approaches among targeted cellular therapies. Despi...
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update
While glatiramer acetate (GA) is generally considered safe during pregnancy and breastfeeding, long-term data, particularl...
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