Related Experiment Videos
[Adverse drug reactions: a pilot study on patient reporting through patient associations]
Daphney Nasrallah-Irles1, Anne Castot, Laure Thomas
1Afssaps, Service de l'Evaluation et de la Surveillance du Risque et de l'Information sur les Médicaments, Saint-Denis, France.
Background:
The expected evolution of monitoring systems for health products, aims at increasing the involvement of patients into health products safety system. As a result, it seems necessary to consider the ability for patients to directly report their own adverse events.
Methods:
A pilot study has been undertaken by Afssaps (Health Agency) for 23 patient associations using a reporting form specially created for patients.
Results:
According to the analysis of the first 200 reports, received from June 2006 to August 2007, the reported adverse events are mostly serious in terms of consequences on patients' quality of life and expected. The quality of information shows that the proposed tools are adequate and could be used in case of a future change in legislation allowing patient reporting of adverse events.
Conclusion:
The patient, eventually helped by his association, may provide contributory safety information, especially regarding side effects affecting daily life.
Related Concept Videos
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Toxicity: Risk factors
Bioavailability Study Design: Healthy Subjects Versus Patients
Pharmaceutical Poisoning: Potential Scenarios
Therapeutic Drug Monitoring: Affecting Factors
Factors Affecting Protein-Drug Binding: Patient-Related Factors
Age stands as a key determinant in protein-drug binding. Neonates, characterized by low albumin content, experience heightened concentrations of unbound drugs such as phenytoin and...