Naslov
MEDICATION ERRORS DETECTED AMONG THE SPONTANEOUSLY REPORTED ADVERSE DRUG REACTIONS TO THE CROATIAN AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES

Autori
Mirošević Skvrce, N. ; Kandžija, N. ; Pacadi, C. ; Mucalo, I. ; Ortner Hadžiabdić, M. ; Tadinac, P. ; Gvozdanović, K. ; Tomić, S.

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

Skup
8. hrvatski kongres farmakologije s međunarodnim sudjelovanjem

Mjesto i datum
Split, Hrvatska, 15.09.2016. - 18.09.2016

Vrsta sudjelovanja
Poster

Vrsta recenzije
Domaća recenzija

Ključne riječi
medication errors, drug reactions, HALMED

Sažetak
Introduction As laid down in the Directive 2010/84/EU amending, Directive 2001/83/EC on the Community code, term 'adverse drug reaction' is noxious and unintended effects resulting not only from authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including overdose, abuse and misuse and suspected adverse reactions associated with occupational exposure. Medication errors are the most common preventable cause of adverse drug reactions (ADRs) in medication practice and present a major public health burden. Materials and methods Non-interventional, observational study aimed at identifying, evaluating and describing preventable adverse drug reactions among the spontaneously reported ADRs was conducted. The previously validated “P-method” was employed as to systematically detect preventable ADRs among the individual case safety reports (ICSR) reported to the Croatian Agency for Medicinal Products and Medical Devices (HALMED). Additionally, medication errors were analyzed according to the „Good practice guide on recording, coding, reporting and assessment of medication errors”1. Results A high proportion of MEs was identified among the spontaneously reported ADRs to the HALMED. In most cases ME was identified only by an assessor and not recognized by a reporter. The two most commonly identified preventability criteria for ADR occurrence were “Incorrect dose” and “Documented hypersensitivity to administered drug”. On the other hand, among MEs without harm “Labelled drug-drug interaction” was the most commonly identified type of ME. Conclusion Our results indicate the need for enforcing a standardized education for reporters and for customizing ADR forms for ME reporting.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

POVEZANOST RADA