Unit:
Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και ΠρόσβασηLibrary of the School of Health Sciences
Author:
Diamantopoulou Maria
Supervisors info:
Κωνσταντίνος Συρίγος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Ηλίας Κοττέας, Αναπληρωτής Καθηγητής,Ιατρική Σχολή, ΕΚΠΑ
Ανδριαννή Χαρπίδου, Ακαδημαϊκή Υπότροφος, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Η σημασία της καταγραφής της ασφάλειας και της αποτελεσματικότητας των φαρμακευτικών σκευασμάτων μετά την πρώτη άδεια κυκλοφορίας από τις ρυθμιστικές αρχές
Translated title:
The importance of recording the safety and efficacy of medicinal products after first marketing authorization by regulatory authorities
Summary:
The present research focuses on exploring the significance of monitoring the safety and
effectiveness of pharmaceutical products after their initial market approval. The emphasis is on the field of Pharmacovigilance, which involves the collection and analysis of data related to drug safety post-approval.
A questionnaire was distributed to 87 healthcare professionals, predominantly in the private sector. The results reveal that a considerable number of professionals are unfamiliar with the Pharmacovigilance system, and many consider their knowledge in this area to be insufficient.
Key observations from the research include a heightened awareness of specific drugs, limited use of the "Yellow Card," correlation between age and the ability to complete the Yellow Card, difficulty in using the recording system, and a high agreement on recording adverse events through
electronic prescribing.
In summary, the research underscores the need for education among healthcare professionals regarding Pharmacovigilance, the enhancement of "Yellow Card" utilization, and improvements in recording systems. Proposed measures include the introduction of educational programs, enhancements in recording systems, reinforcement of electronic prescribing, and the
establishment of compensated Pharmacovigilance services, along with regular monitoring of adverse events.
In conclusion, Pharmacovigilance plays a crucial role in ensuring the safety and effectiveness of drugs, requiring active participation from healthcare professionals. The proposed measures are essential steps toward improving the management of pharmaceutical products in the market.
Main subject category:
Health Sciences
Keywords:
Pharmacovigilance
File:
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