Naslov
Medication Errors Detected Among the Spontaneously Reported Adverse Drug Reactions to the Croatian Agency for Medicinal Products and Medical Devices

Autori
Macolić Šarinić, M. ; Kandžija, N. ; Pacadi, C. ; Mucalo, I. ; Ortner Hadžiabdić, M. ; Krnić, D. ; Mirošević Skvrce, N. ;

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Abstracts ; INTERNATIONAL SOCIETY OF PHARMACOVIGILANCE / - , 2015, 940-940

Skup
15th ISoP Annual Meeting ˝Cubism in pharmacovigilance˝

Mjesto i datum
Prag, Češka Republika, 27.10.2015. - 30.10.2015

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
HALMED, medication errors, drug reactions

Sažetak
Background: Medication errors are the most common preventable cause of adverse drug reactions (ADRs) in medication practice and present a major public health burden. Aim of the study: The objective of the study was to identify, evaluate and describe medication errors (ME) among the spontaneously reported ADRs to the Croatian Agency for Medicinal Products and Medical Devices (HALMED). Method: A retrospective observational study was performed on 100 spontaneously reported ADRs in 2013. The previously validated ‘‘P-method’’1 was employed to systematically detect MEs in individual case safety reports (ICSR) sent to the Croatian pharmacovigilance centre (PVC) at HALMED. ME that lead to ADR identified by reporter as well as ME suspected by assessor are described. Results: Ninety-seven MEs were detected in 100 analysed cases [gender 38 M, 62 F ; age 56.1 ± 21.9 (range 2–93) ; number of medicines 2.8 ± 2, 0 (range 1–13), comorbidities 1.7 ± 1.2 (range 0–5)]: 21, 65 % (n=21) related to a suspected drug led to an ADR, whereas 78, 3 %(n=76) related to both suspected drug or concomitant therapy did not lead to harm. In only 3 cases (14, 29 %) ME that lead to ADR was identified by reporter. Out of 36 (36 %) spontaneously reported serious ADRs, 9 (25 %) were caused by medication errors. The most commonly identified preventability criteria for ADR occurrence was ‘‘Drug–drug interaction’’ reported in 24.7 % of overall MEs, followed by ‘‘Incorrect dose’’ (21.6 %). Conclusion: A high proportion of MEs was identified in ICSRs sent to PVC with one fourth of the serious ADRs caused by medication errors. In 20 % of reported ADRs MEs was identified. In most cases (86 %), ME was suspected only by assessor. In process of identifying a medication error in practice it is very hard to check that in particular case it was unintended failure in the drug treatment process. Process of identifying ME is very sensitive and relationship between reporter and national pharmacovigilance centre as well as legal implications in the context of HCP liability in some countries must be taken into account. Our results indicate the need to capture suspected ME by assessor in databases as well as promoting reporting of ME and customizing ADR forms for reporting ME.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

POVEZANOST RADA