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Adverse Event Reporting: How reliable is the new legislation?
The new legislation on pharmacovigilance will be applicable from July next year. However, the current system for monitoring the safety of medicines on the European market is already being affected by these upcoming regulations.
One of the benefits of the new procedures is that, for example, will allow patients to report adverse drug reactions directly to the competent authorities and reporting of adverse reactions will be broadened to cover, medication errors. Although it sounds as a pretty logical move there are doubts regarding how reliable is a patient when coming across self-reporting particular symptoms.
Laurie Scudder, DNP, NP from NP Alternatives, Ellicott City, Maryland on her Patient Report of Chemotherapy Adverse Effects refers to this as "Earlier research has documented the lack of congruence between patient and healthcare professional perception of symptoms and between patient report of and healthcare professional perception of patient symptoms. Although numerous studies have examined the issue of patient self-assessment of symptoms compared with caregiver or healthcare professional assessment, surprisingly little research has examined the impact of timing of patient report. Earlier studies have found that patients have difficulty accurately recalling their own symptoms and correctly identifying the stage in the chemotherapy cycle at which they occurred."
Back in Europe, Mick Foy, the Group Manager of the Vigilance Intelligence and Research Group of the MHRA is very well involved with the new legislative requirements in Directive 2010/84/EU, and how the regulatory expectations have and will change. Being well aware of the potential impact of the new regulation - Mick will be addressing an introduction to these and will compare international regulations and requirements at the Adverse Event Reporting - Online Training Course. Furthermore, he will be discussing how regulations could also affect current IT systems and electronic transfer.
The New Pharmacovigilance Legislation and its Impact on Adverse Event Reporting, Mick Foy, Head Pharmacovigilance Signal Management Group, MHRA
For more news: https://www.adverseeventreportingtraining.com/
Page Updated Last on: Jun 09, 2011