ReviewEuropean journal of clinical pharmacology2012
A plea for a more epidemiological and patient-oriented pharmacovigilance.
Review in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.Frontiers in medicine · 2019Pooled it
- The value of patient reporting to the pharmacovigilance system: a systematic review.British journal of clinical pharmacology · 2017Pooled it
- Real-World Data for Safety Studies: Challenges and Opportunities From the Italian Multiple Sclerosis and Related Disorders Register.Pharmacoepidemiology and drug safety · 2026Article
- Jordanians' knowledge, attitude and practice regarding adverse drug reactions reporting.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023Article
- Discrepancy between patient- and healthcare provider-reported adverse drug reactions in inflammatory bowel disease patients on biological therapy.United European gastroenterology journal · 2021Article
- The Perception of Primary School Teachers Regarding the Pharmacotherapy of Attention Deficit Hyperactivity Disorder.International journal of environmental research and public health · 2021Article
- Public Awareness about Medicine Information, Safety, and Adverse Drug Reaction (ADR) Reporting in Dammam, Saudi Arabia.Pharmacy (Basel, Switzerland) · 2020Article
- Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database.Drugs - real world outcomes · 2018Article
- Assessment of Knowledge, Attitude and Barriers towards Pharmacovigilance among Physicians and Pharmacists of Abbottabad, Pakistan.Pharmacy (Basel, Switzerland) · 2018Article
- Adverse drug reactions (ADRS) reporting: awareness and reasons of under-reporting among health care professionals, a challenge for pharmacists.SpringerPlus · 2016Article
- Pediatric drug safety signal detection: a new drug-event reference set for performance testing of data-mining methods and systems.Drug safety · 2015Article
- The out-of-focus bias in drug surveillance.European journal of clinical pharmacology · 2013Article
- Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities?Drug safety · 2012Review
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
The present work has the main objective of summarizing the history of pharmacovigilance and the associated methods and legislation and of showing how it could/should be reformulated in terms of a transition from a drug-centered to a patient/population-centered approach. The recurrent emergencies associated with new drug molecules raise many questions about the efficacy and efficiency of methodological tools as well as the role of regulatory systems. Drugs cannot be considered as an independent variable: the evaluation of all their effects must take into account the real contexts in which they are used and which affect not only their efficacy but also their tolerability and safety. Specific emphasis is given to recent and promising developments focused on the participation of patients and populations as key actors in producing knowledge that could technically integrate what has been produced so far and allow the evolution of surveillance from a role of controlling severe adverse reactions attributable to individual molecules to one of promoting a comprehensive assessment of the benefit/risk profile of drugs as they are utilized in society.
Indexed as
Identifiers
21773732What 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.