Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 2 of Module III on pharmacovigilance inspections.
Disproportionality analysis of spontaneous reporting systems is usually used to identify positive signals, meaning drugevent pairs reported more often than expected. The same statistical structure also has a lower-reporting side. A reporting odds ratio (ROR) above unity indicates higher-than-expected reporting, whereas an ROR below unity indicates lower-than-expected reporting. Neither result directly estimates incidence, absolute risk, or causality.
Prescribing cascades (PCs) occur when an adverse drug reaction (ADR) is intentionally or unintentionally treated with an additional medication, potentially perpetuating inappropriate polypharmacy. Digital tools that systematically support the identification of potential PCs during medication review are lacking. Here, we describe the development of an algorithm designed to identify drug pairs potentially compatible with PCs and evaluate its classification performance.
And much more...
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 2 of Module III on pharmacovigilance inspections
Benefits of sodium oxybate continue to outweigh risks in people with alcohol dependency
As with all licensed medicines, the MHRA will keep the safety and effectiveness of lurbinectedin under close review.
Prescribing cascades (PCs) occur when an adverse drug reaction (ADR) is intentionally or unintentionally treated with an additional medication, potentially perpetuating inappropriate polypharmacy. Digital tools that systematically support the identification of potential PCs during medication review are lacking. Here, we describe the development of an algorithm designed to identify drug pairs potentially compatible with PCs and evaluate its classification performance.
As healthcare providers begin to embed agentic AI into their workflows, effective governance and accountability becomes key.
Diagnostic accuracy in Large Language Models (LLM) is an increasing concern as physicians employ LLMs into their medical practice. We measured whether diagnostic correctness in LLMs changed after a certainty challenge or clinician specialty framing.
Disproportionality analysis of spontaneous reporting systems is usually used to identify positive signals, meaning drug–event pairs reported more often than expected. The same statistical structure also has a lower-reporting side. A reporting odds ratio (ROR) above unity indicates higher-than-expected reporting, whereas an ROR below unity indicates lower-than-expected reporting. Neither result directly estimates incidence, absolute risk, or causality.
The aim of this study was to analyze the structure, readability, and informational content of educational materials used in REMS programs to assess their potential to communicate drug-related risks and support safe use for 13 drugs with active REMS programs as of 2021.
Trust is a central obstacle to realizing the potential of AI agents at work. Employees are unlikely to give agents meaningful autonomy if they are uncertain about their reliability, intentions, or ability to act safely. Research suggests adoption improves when organizations are explicit about an agent’s limitations, emphasize competence over friendliness, connect its recommendations to users’ broader goals, frame it as a helper rather than an autonomous authority, and preserve human control over consequential decisions.
Pictures used in this newsletter were generated by AI.