ArticleDrug safety2011
Modified prescription-event monitoring studies: a tool for pharmacovigilance and risk management.
Article in Drug safety, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 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
18 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.Drug safety · 2024Pooled it
- Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.Frontiers in medicine · 2019Pooled it
- Preventive pharmacologic treatments for episodic migraine in adults.Journal of general internal medicine · 2013Pooled it
- Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: Results from a two-armed, open-label, cluster-randomized, community study.PLoS neglected tropical diseases · 2020Trial
- Trial
- Current Challenges in Monitoring the Safety and Utilisation of the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs): A UK Perspective.Drug safety · 2026Article
- After the green light: Evaluating drugs in Phase IV studies.Indian journal of pharmacology · 2026Review
- The Role of Pharmacogenomics in Rare Diseases.Drug safety · 2024Review
- Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Event Monitoring and Evaluation by Community Pharmacists in Japan: A Pilot Study on Fenofibrate and Pemafibrate.Current drug safety · 2022Article
- Use of Statins Among Patients Taking Levothyroxine: an Observational Drug Utilization Study Across Sites.Journal of the Endocrine Society · 2021Article
- Active Safety Surveillance in Africa: Pragmatism and Agility.Drug safety · 2018Article
- A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms.Drug safety · 2017Article
- Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.Drug safety · 2015Review
- A comparison of active adverse event surveillance systems worldwide.Drug safety · 2014Review
- Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England.Drug safety · 2013Article
- Article
- Reasons for and time to discontinuation of rimonabant therapy: a modified prescription-event monitoring study.Drug safety · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Prescription-Event Monitoring (PEM) is a well established postmarketing surveillance technique designed to monitor the overall safety of newly marketed medicines as used in real-life clinical practice, usually in cohorts of at least 10 000 patients. At the Drug Safety Research Unit in the UK we are now moving towards a more targeted safety surveillance known as Modified PEM (M-PEM). These studies combine the advantages of conventional PEM studies (in monitoring general safety and identification of unexpected risks of a medicine) with that of a more targeted safety study that addresses specific questions (to better understand known or partially known risks with a medicine). Through the use of enhanced data collection questionnaires, M-PEM expands the range of applications of conventional PEM, which include more detailed characterization of real-life drug use, adherence to prescribing recommendations and targeted analysis of events requiring special monitoring by regulatory authorities. A particularly useful application is the evaluation of the safety of a medicine in special populations or subgroups (e.g. patients switching from another therapy or patients with a particular risk factor) or following important changes in the product's lifecycle (e.g. a licensing or formulation change). M-PEM studies therefore have an important contribution to make to pharmacovigilance and the risk management of medicines by providing valuable information on the use of new medications under real-life situations.
Indexed as
Identifiers
22077508What 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.