Real-World Safety Outcomes and Policy Responses to Adverse Drug Reactions

Adverse drug reactions (ADRs) remain a major, and often preventable, source of patient harm even after drugs have received marketing authorization. In line with the Drugs Outcomes Research and Policies section’s focus on drug policies that improve access to safe, effective, quality-assured medicines (WHO) — ensuring reliable and consistent availability, appropriateness of prescribing, affordability, and protection of patients from catastrophic expenditure — this Research Topic focuses on generating real-world evidence on ADR outcomes among marketed drugs and evaluating the policy and regulatory responses designed to reduce their impact.We welcome original research, meta-analyses, and policy studies on:• Real-world and post-marketing safety outcomes related to adverse drug reactions in drugs with existing marketing authorization• Health policy and regulatory interventions to improve drug safety, availability, and affordability, including prescribing policies, medication adherence programs, and access policies• Cost-effectiveness and health-related quality-of-life outcomes linked to adverse drug reaction management• Drug utilization studies and prioritization frameworks relevant to adverse drug reaction preventionOut of scope, in line with the section’s editorial policy:• Pharmacovigilance and disproportionality analyses of adverse drug reactions using spontaneous reporting databases (e.g., FAERS and similar databases)• Clinical studies of drugs that have not yet received marketing authorization• Preclinical studies• Studies of medical devices not containing drugs• Studies on nutraceuticals, vitamins, wound-healing products, herbal medicines, or traditional medicines• Routine pharmacy dispensing operations, patient counselling/education services, and general science communication• Case reports, clinical trials, or observational studies (e.g., surgical/anesthesia protocols, oncology treatment comparisons, risk-prediction models) where ADR/drug safety is not the primary outcome, or that lack a real-world evidence or policy-analysis framework Topic editors: Zhiyao He, Santosh Chokkakula Source: https://www.frontiersin.org/research-topics/85166/real-world-safety-outcomes-and-policy-responses-to-adverse-drug-reactions