ReviewDrug safety2013
Postmarketing safety surveillance : where does signal detection using electronic healthcare records fit into the big picture?
Review in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
47 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review.Pharmacoepidemiology and drug safety · 2023Pooled it
- Drug-drug interactions with direct oral anticoagulants associated with adverse events in the real world: A systematic review.Thrombosis research · 2020Pooled it
- Uncovering the Hidden Hurdles: Exploring Challenges in Pediatric Pharmacovigilance in the Netherlands.Drug safety · 2026Article
- Establishment of a visualization platform for ADR query and analysis: an example of severe skin adverse reactions caused by sulfonylureas.European journal of clinical pharmacology · 2025Article
- Low-Dose Oral Minoxidil and Associated Adverse Events: Analyses of the FDA Adverse Event Reporting System (FAERS) With a Focus on Pericardial Effusions.Journal of cosmetic dermatology · 2025Article
- Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Safety assessment of Tafamidis: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events.BMC pharmacology & toxicology · 2024Article
- Editorial: Traditional and innovative approaches for signal detection.Frontiers in drug safety and regulation · 2024Article
- A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS).Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023Article
- Future of ChatGPT in Pharmacovigilance.Drug safety · 2023Article
- Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.Drug safety · 2023Article
- Article
- Generalizability of machine learning methods in detecting adverse drug events from clinical narratives in electronic medical records.Frontiers in pharmacology · 2023Article
- Hierarchy-aware Adverse Reaction Embeddings for Signal Detection.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2022Article
- Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness.Chinese journal of integrative medicine · 2021Observational
- Cardiovascular Safety Profile of Romosozumab: A Pharmacovigilance Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS).Journal of clinical medicine · 2021Article
- Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021Article
- Detecting Medicine Safety Signals Using Prescription Sequence Symmetry Analysis of a National Prescribing Data Set.Drug safety · 2020Article
- JAK Inhibitors Safety in Ulcerative Colitis: Practical Implications.Journal of Crohn's & colitis · 2020Review
- Detecting and Filtering Immune-Related Adverse Events Signal Based on Text Mining and Observational Health Data Sciences and Informatics Common Data Model: Framework Development Study.JMIR medical informatics · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The safety profile of a drug evolves over its lifetime on the market; there are bound to be changes in the circumstances of a drug's clinical use which may give rise to previously unobserved adverse effects, hence necessitating surveillance postmarketing. Postmarketing surveillance has traditionally been carried out by systematic manual review of spontaneous reports of adverse drug reactions. Vast improvements in computing capabilities have provided opportunities to automate signal detection, and several worldwide initiatives are exploring new approaches to facilitate earlier detection, primarily through mining of routinely-collected data from electronic healthcare records (EHR). This paper provides an overview of ongoing initiatives exploring data from EHR for signal detection vis-à-vis established spontaneous reporting systems (SRS). We describe the role SRS has played in regulatory decision making with respect to safety issues, and evaluate the potential added value of EHR-based signal detection systems to the current practice of drug surveillance. Safety signal detection is both an iterative and dynamic process. It is in the best interest of public health to integrate and understand evidence from all possibly relevant information sources on drug safety. Proper evaluation and communication of potential signals identified remains an imperative and should accompany any signal detection activity.
Indexed as
Identifiers
23377696What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.