Pregled bibliografske jedinice broj: 1270374
Adverse Drug Reactions Arising from the Use of the Products Outside the Terms of the Marketing AuthorisationAdverse Drug Reactions Arising from the Use of the Products Outside the Terms of the Marketing Authorisation
Adverse Drug Reactions Arising from the Use of the Products Outside the Terms of the Marketing AuthorisationAdverse Drug Reactions Arising from the Use of the Products Outside the Terms of the Marketing Authorisation // Research in Social and Administrative Pharmacy
Ženeva, Švicarska, 2018. str. 928-934 (poster, međunarodna recenzija, sažetak, znanstveni)
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Naslov
Adverse Drug Reactions Arising from the Use of the
Products Outside the Terms of the Marketing
AuthorisationAdverse Drug Reactions Arising from
the Use of the Products Outside the Terms of the
Marketing Authorisation
(Adverse Drug Reactions Arising from the Use of the
Products Outside the Terms of the Marketing
Authorisation)
Autori
Mirošević Skvrce, N. ; Mucalo, I. ; Galić, I. ; Pacadi, C. ; Kandžija, N.
Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni
Izvornik
Research in Social and Administrative Pharmacy
/ - , 2018, 928-934
Skup
18th annual meeting of international society of pharmacovigilance
Mjesto i datum
Ženeva, Švicarska, 11.11.2018. - 14.11.2018
Vrsta sudjelovanja
Poster
Vrsta recenzije
Međunarodna recenzija
Ključne riječi
drug reactions ; pharmacovigilance ; HALMED
Sažetak
Background/Introduction: New European (EU) pharmacovigilance (PV) legislation, introduced in 2012, widened the scope of an Adverse Drug Reactions 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). Objective/Aim: To describe 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. 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, on a case-by-case basis, 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. Majority were due to medication errors (N = 155). Off-label use was identified in 87 reports, while misuse and overdose were identified in 11 and 39 reports, respectively. There were no reports of abuse among the analysed reports. In only 27 out of 128 reports (21.09%), reporters recognized an ADR as a consequence of use outside MA. Conclusion: The main observation derived from this study was a rather high proportion of ADR reports that arise from the medicinal product use outside the use of MA. Moreover, a considerable portion of ADRs outside the terms of the MA was not- assessable nor recognized by a reporter, suggesting the need for targeted education and improving reporting systems, since forms currently used were not designed for reporting ADRs outside the MA. Disclosure of Interest: None declared.
Izvorni jezik
Engleski
Znanstvena područja
Farmacija
