Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
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Under-reporting of Adverse Drug Reactions: The Need for an Automated Reporting System
Although upwards of 32,000 adverse drug reactions are reported to Health Canada annually, this represents only approximately 5% of cases experienced by Canadians every year. This gross display of underreporting not only results in unrepresentative data in regards to adverse drug reactions, but further discredits databases used by healthcare ...
openaire +2 more sources
Awareness among nurses about reporting of adverse drug reactions in Sweden
Elisabet Ekman,1–3 Göran Petersson,2 Sven Tågerud,3 Martin Bäckström41Regional Pharmacovigilance Unit, R & D Centre Skåne, Skåne University Hospital, Lund, 2eHealth Institute ...
Ekman E+3 more
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Assessing the 2004-2018 fentanyl misusing issues reported to an international range of adverse reporting systems [PDF]
© 2019 Schifano, Chiappini, Corkery and Guirguis. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY).
Chiappini, Stephania+3 more
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Background While medication labels are considered the authoritative resource for medication information, emerging research suggests that patient-generated health data (PGHD) are a valuable tool to understand the ways in which patients experience ...
David A. Blaser+6 more
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Systematic review of the safety of medication use in inpatient, outpatient and primary care settings in the Gulf Cooperation Council countries [PDF]
Background Errors in medication use are a patient safety concern globally, with different regions reporting differing error rates, causes of errors and proposed solutions.
Abu Yassin+95 more
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BackgroundRobust adverse drug event (ADE) reporting systems are crucial to monitor and identify drug safety signals, but the quantity and type of ADEs captured may vary by system characteristics.
Erica Y Lau+4 more
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Linking Activity Theory Within User-Centered Design: Novel Framework to Inform Design and Evaluation of Adverse Drug Reaction Reporting Systems in Pharmacy (Preprint) [PDF]
Joel Fossouo Tagne+3 more
openalex +1 more source
Geriatric pharmacotherapy : optimisation through integrated approach in the hospital setting [PDF]
Since older patients are more vulnerable to adverse drug-related events, there is a need to ensure appropriate prescribing in these patients in order to prevent misuse, overuse and underuse of drugs.
A Corsonello+63 more
core +1 more source
Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis
Background : Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the
Francesca Scicchitano+18 more
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