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[Adverse drug reactions: a pilot study on patient reporting through patient associations]. 2008

Daphney Nasrallah-Irles, and Anne Castot, and Laure Thomas, and Samy Babai, and Bernard Delorme, and Hervé Le-Louët
Afssaps, 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. CONCLUSIONS The patient, eventually helped by his association, may provide contributory safety information, especially regarding side effects affecting daily life.

UI MeSH Term Description Entries
D008991 Monitoring, Physiologic The continuous measurement of physiological processes, blood pressure, heart rate, renal output, reflexes, respiration, etc., in a patient or experimental animal; includes pharmacologic monitoring, the measurement of administered drugs or their metabolites in the blood, tissues, or urine. Patient Monitoring,Monitoring, Physiological,Physiologic Monitoring,Monitoring, Patient,Physiological Monitoring
D010361 Patients Individuals participating in the health care system for the purpose of receiving therapeutic, diagnostic, or preventive procedures. Clients,Client,Patient
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D004358 Drug Therapy The use of DRUGS to treat a DISEASE or its symptoms. One example is the use of ANTINEOPLASTIC AGENTS to treat CANCER. Chemotherapy,Pharmacotherapy,Therapy, Drug,Chemotherapies,Drug Therapies,Pharmacotherapies,Therapies, Drug
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012449 Safety Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property. Safeties
D064420 Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals. Drug-Related Side Effects and Adverse Reaction,Adverse Drug Event,Adverse Drug Reaction,Drug Side Effects,Drug Toxicity,Side Effects of Drugs,Toxicity, Drug,Adverse Drug Events,Adverse Drug Reactions,Drug Event, Adverse,Drug Events, Adverse,Drug Reaction, Adverse,Drug Reactions, Adverse,Drug Related Side Effects and Adverse Reaction,Drug Related Side Effects and Adverse Reactions,Drug Side Effect,Drug Toxicities,Effects, Drug Side,Reactions, Adverse Drug,Side Effect, Drug,Side Effects, Drug,Toxicities, Drug

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