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Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some countries consumers) to identify and report any adverse events to their national pharmacovigilance center, health authority (such as the European Medicines Agency or FDA), or to the drug manufacturer ...
An adverse event can also be declared in the normal treatment of a patient which is suspected of being caused by the medication being taken or a medical device used in the treatment of the patient. In Australia, 'Adverse EVENT' refers generically to medical errors of all kinds, surgical, medical or nursing related.
Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose Results in death; Is life-threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability/incapacity
MedWatch was founded in 1993 to collect data regarding adverse events in healthcare. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary ...
Electronic medical record systems can be programmed to fire alerts when a potential adverse drug event is about to occur or has already occurred.[3,4] Automated adverse drug event monitors can search for keywords or phrases throughout the patient's medical record to identify drug therapies, laboratory results, or problem lists that may indicate ...
Between 1998 and 2007, 33 serious adverse drug or device reactions have been reported by RADAR investigators. The toxicities involved multiple biological system and included thrombotic thrombocytopenic purpura (TTP) (ticlopidine and clopidogrel), thromboembolism (thalidomide and lenalidomide), liver failure (gemtuzumab and nevirapine), hypersensitivity (drug eluting coronary arterial stents ...
With primary objective of identify the earliest possible pharmacovigilance signals, the usage of VigiBase is permitted and accessed by the following authorities: [5] Member states: Authorized centre of all member countries have the free access to the data through VigiSearch/ VigiLyze, or can be requested for data to UMC. Although these data ...