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Pregled bibliografske jedinice broj: 1037291

Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation

Mirosevic Skvrce, Nikica; Galic, Iva; Pacadi, Carmen; Kandzija, Neva; Mucalo, Iva
Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation // Research in Social and Administrative Pharmacy, 18 (2019), 1; 1551-7411, 7 doi:10.1016/j.sapharm.2019.10.003 (međunarodna recenzija, članak, znanstveni)

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Naslov
Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation

Autori
Mirosevic Skvrce, Nikica ; Galic, Iva ; Pacadi, Carmen ; Kandzija, Neva ; Mucalo, Iva

Izvornik
Research in Social and Administrative Pharmacy (1551-7411) 18 (2019), 1; 1551-7411, 7

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
adverse drug reactions ; medication error ; overdose ; new pharmacovigilance legislation ; medication safety

Sažetak
Background New European (EU) pharmacovigilance (PV) legislation, introduced in 2012, widened the scope of an Adverse Drug Reactions (ADR) definition so that it also includes noxious and unintended response to a medicinal product arising from the use outside the terms of the marketing authorisation (MA), whereby the use outside the MA also includes off-label use, overdose, misuse, abuse and medication errors (MEs). Objectives To explore the influence of the new EU PV legislation on the quality and reporting rate of ADRs arising from the use outside the terms of the MA reports in the Croatian pharmacovigilance database. Methods A retrospective, observational study of the HALMED PV database was undertaken before and after the implementation of the new legislation in Croatia. The outcome measure included ADRs arising from the use of the products outside the terms of the MA. An assessment was performed based on the information provided in a reference document, an SmPC, using predefined criteria. Results Among 679 ADRs included in the analysis, 162 (23, 9%) ADR reports were related to the use outside of the MA, 370 (54, 5%) were related to the use within the MA and 147 (21, 6%) were adjudged as not-assessable. Our study demonstrated a significant increase in the number of ADRs arising from the use outside the terms of the MA after the implementation of the new legislation (P = 0, 039), primarily due to a notable increase in the number of overdose reports received by the poisoning centre, while the number of ADRs caused by MEs did not change significantly (P = 0, 672). Conclusion This study elucidated partial implementation of the new EU PV legislation and the need for instilling proper education for patients and HCPs, improving reporting systems and strengthening collaboration between relevant stakeholders.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija



POVEZANOST RADA

Ustanove:
Farmaceutsko-biokemijski fakultet, Zagreb

Profili:

Avatar Url Iva Mucalo (autor)

Poveznice na cjeloviti tekst rada:

doi

Citiraj ovu publikaciju:

Mirosevic Skvrce, Nikica; Galic, Iva; Pacadi, Carmen; Kandzija, Neva; Mucalo, Iva
Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation // Research in Social and Administrative Pharmacy, 18 (2019), 1; 1551-7411, 7 doi:10.1016/j.sapharm.2019.10.003 (međunarodna recenzija, članak, znanstveni)
Mirosevic Skvrce, N., Galic, I., Pacadi, C., Kandzija, N. & Mucalo, I. (2019) Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation. Research in Social and Administrative Pharmacy, 18 (1), 1551-7411, 7 doi:10.1016/j.sapharm.2019.10.003.
@article{article, author = {Mirosevic Skvrce, Nikica and Galic, Iva and Pacadi, Carmen and Kandzija, Neva and Mucalo, Iva}, year = {2019}, pages = {7}, DOI = {10.1016/j.sapharm.2019.10.003}, chapter = {1551-7411}, keywords = {adverse drug reactions, medication error, overdose, new pharmacovigilance legislation, medication safety}, journal = {Research in Social and Administrative Pharmacy}, doi = {10.1016/j.sapharm.2019.10.003}, volume = {18}, number = {1}, issn = {1551-7411}, title = {Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation}, keyword = {adverse drug reactions, medication error, overdose, new pharmacovigilance legislation, medication safety}, chapternumber = {1551-7411} }
@article{article, author = {Mirosevic Skvrce, Nikica and Galic, Iva and Pacadi, Carmen and Kandzija, Neva and Mucalo, Iva}, year = {2019}, pages = {7}, DOI = {10.1016/j.sapharm.2019.10.003}, chapter = {1551-7411}, keywords = {adverse drug reactions, medication error, overdose, new pharmacovigilance legislation, medication safety}, journal = {Research in Social and Administrative Pharmacy}, doi = {10.1016/j.sapharm.2019.10.003}, volume = {18}, number = {1}, issn = {1551-7411}, title = {Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation}, keyword = {adverse drug reactions, medication error, overdose, new pharmacovigilance legislation, medication safety}, chapternumber = {1551-7411} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Social Science Citation Index (SSCI)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE

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