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Open access Sep 2026

Physician Understanding and Perceptions of Risk Communication Related to Drugs Covered by Risk Evaluation and Mitigation Strategy Programs.

PURPOSE To help ensure that a drug's benefits outweigh its risks, the US Food and Drug Administration may require a Risk Evaluation and Mitigation Strategy (REMS) program with requirements such as laboratory tests or special education. Since physicians are often responsible for REMS testing or education, it is critical...

Heidi Zakoul, Carol Cosenza, Su Been Lee et al. · 0 citations
Review Open access Sep 2026

Mapping benefits, risks, and challenges of expedited drug approval programs

Objective: This scoping review identified the benefits, risks, and challenges associated with expedited drug approval programs implemented by regulatory agencies. Methods: A systematic search was conducted in Embase, Scopus, PubMed, Lilacs, Cochrane, and Google Scholar, complemented by gray literature, to identify revi...

Jenny Patricia Clavijo Rojas, Eduardo A. Rueda Barrera, J. J. López · 0 citations
Open access Sep 2026

Important potential risks not reflected in Japanese drug labeling: implications for risk management plan termination

Risk management plans (RMPs) support lifecycle management of drug-related risks. In Japan, however, their use in clinical practice remains limited, and healthcare professionals often rely on the package insert for safety information. After RMP termination at re-examination, healthcare professionals may no longer readil...

Natsuko Kameyama, Ayana Ide, Hideki Maeda · 0 citations
Review Open access Sep 2026

Electronic prescribing and patient safety: a rigour-stratified systematic review of medication error, adverse drug events, workflow, and communication

Background Electronic prescribing is promoted to improve medication safety. Whether its benefit differs between process failure and patient harm is rarely asked. Objective To synthesise the evidence on electronic prescribing and medication error, adverse drug events, workflow and communication against the designs able...

S. Bhavana, Sanjay N. Pat Il, R. J. Varshini et al. · 0 citations
Review Open access Sep 2026

PHARMACOVIGILANCE: A FRAMEWORK FOR SAFER THERAPEUTICS PRACTICES

The study concludes that a robust pharmacovigilance framework significantly contributes to safer therapeutic practices and improved patient outcomes.

Samaraddhi Vishwakarma, Akshay Kumar · 0 citations
Review Open access Aug 2026

Comparative Evaluation of Pharmacovigilance Regulatory Requirements in India, USA and European Union

Pharmacovigilance is an essential scientific and regulatory discipline concerned with the detection, assessment, understanding and prevention of adverse drug reactions and other medicine-related problems throughout the life cycle of medicinal products. As pre-marketing clinical trials involve limited and selected popul...

B. N. Narasimha Rao, M. Rao, A. Veni et al. · 0 citations

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