Naslov
ANALYSIS OF ADVERSE DRUG REACTIONS FOR BIOLOGICAL MEDICINAL PRODUCTS AND BIOSIMILARS REPORTED TO THE CROATIAN AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES

Autori
Gvozdanović Katarina, Stanić Benić Mirjana, Javor Eugen, Dolinić Barbara, Krnić Darko, Tomić Siniša

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, prošireni 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
Međunarodna recenzija

Ključne riječi
Biologicals, biosimilars, adverse effect, batch number

Sažetak
Introduction Concept of biosimilars continuously raises numerous questions among health care professionals (HCPs) and patients, mainly related to their efficacy and safety compared to the original biological product and also with regards to drug interchangeability. Post-marketing safety monitoring is mandatory for all medicines, however monitoring adverse reactions (ADRs) of biological and biosimilar medicines requires special attention due to their complex structure and manufacturing process. For this group of medicines it is extremely important to report ADRs using brand name of suspected medicine and to indicate the batch number in order to enable traceability. Materials and methods ADR data was extracted from the Croatian national ADR database (VigiBase) by filtering ADR reports containing biological or biosimilar products. A descriptive data analysis was preformed with the special emphasis on the availability of data on batch number and brand name in the reported ADRs, reporter qualification and seriousness of the report. Results A high proportion of analysed ADR reports contain data on both international non- proprietary name and brand name, however batch numbers are generally lacking. As per seriousness, most of the reports are considered serious. Majority of reporters were physicians although increasing trend of reporting by nurses was noticed. Conclusion ADR reports could be valuable source of information about safety and efficacy of biologicals and biosimilars but the prerequisite is quality of data provided in the ADR report. High quality ADR data will allow HALMED to tailor further evidence-based regulatory actions related to this type of medicines.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti

POVEZANOST RADA