Ovrednotenje stanja in možnosti nadgradnje farmakovigilančnega sistema za poročanje o neželenih učinkih zdravil za uporabo v humani medicini v Sloveniji

Žitnik, May (author), Kos, Mitja (mentor), Radoha Bergoč, Milena (comentor)

Poročanje o domnevnih neželenih učinkih dosega 6 % vseh dejanskih neželenih učinkov. To lahko vpliva na varnost uporabe zdravil po prihodu zdravila na trg. Poročanje je za zdravstvene delavce v Sloveniji obvezno, vendar je v praksi težko poročati vsak domnevni neželeni učinek zdravila. Namen projekta, ki ga izvajajo na Javni agenciji za zdravila in medicinske pripomočke, je spodbuditi poročanje zdravstvenih delavcev z olajšanjem poročanja. Namen magistrske naloge je bil ovrednotiti sistem farmakovigilance v Sloveniji za poročanje o domnevnih neželenih učinkih zdravil za uporabo v humani medicini in iskati možnosti nadgradnje le-tega. Izpostavili smo izzive, s katerimi se deležniki srečujejo, in možnosti izboljšav, ki jih želijo v prihodnosti, ter s tem ocenili možnosti za nadgradnjo. Analizirali smo podatke o številu poročil o domnevnih neželenih učinkih zdravil, zbranih v okviru projekta informacijske podpore farmakovigilanci, zdravil za uporabo v humani medicini, v katerega sta bili vključeni instituciji v lekarniškem okolju in na primarni ravni zdravstvene dejavnosti. Z metodo fokusnega panela smo kvalitativno ovrednotili diskusijo s pomočjo programa NVivo 11 Pro. Na fokusnem panelu je sodelovalo pet ključnih deležnikov: predstavnik generične industrije, regulatorja, lekarniškega in bolnišničnega okolja ter foruma inovativne industrije. Rezultati kvantitativne analize prejetih podatkov iz projekta so pokazali, da se je ob umestitvi obrazca za poročanje v informacijski sistem, ki ga zdravstveni delavec uporablja pri vsakdanjem delu, povečalo poročanje o domnevnih neželenih učinkih zaradi skrajšanja časa poročanja in aktivno vključitvijo v projekt, saj so s tem imeli dodatno motivacijo in izobraževanje o farmakovigilanci. Rezultati fokusnega panela so ponudili 7 dejavnikov neporočanja, ki so temelj nadgradnje: znanje zdravstvenih delavcev, ozaveščenost zdravstvenih delavcev, pomanjkanje motivacije zdravstvenih delavcev, sledljivosti zdravil, časa, kadra in problematika informacijskih sistemov. Dejavniki, ki jih moramo prioritetno reševati, so: znanje zdravstvenih delavcev, ozaveščenost zdravstvenih delavcev in pomanjkanje motivacije zdravstvenih delavcev. Ti so med seboj povezani in bi z nadgradnjo kateregakoli od njih nadgradili tudi ostala dva.

• Language: Slovenian
• Keywords: neželeni učinki zdravil, farmakovigilančni sistem, Slovenija, ovrednotenje in nadgradnja sistema, dejavniki neporočanja o domnevnih neželenih učinkov zdravil
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2019
• PID: 20.500.12556/RUL-111806
• Publication date in RUL: 14.10.2019

Secondary language

• Language: English
• Title: Evaluation of the current state and the possibility of upgrading the pharmacovigilance system for reporting adverse reactions of a medicinal product for human use in Slovenia

Abstract

Only 6% of adverse reactions are reported compared to all possible adverse reactions. This can have an effect on the safety of the medicine after the medicine has already received marketing authorization. Although reporting is mandatory for health-care workers in Slovenia, it is difficult to report all adverse reactions. The purpose of the project, which is carried out by Javna agencija za zdravila in medicinske pripomočke, is to encourage reporting by health-care workers by making the reporting process easier. The purpose of this masters’ thesis was to evaluate the current state of the Slovenian pharmacovigilance system for reporting adverse reactions of a medicinal product for human use and the possibilities of upgrading the system. We emphasized the challenges which the stakeholders face regularly and the possibilities of future improvement, evaluating the possibility for upgrades. We analyzed the number of reports of adverse reactions gathered in the project of informational support for pharmacovigilance for the use of medicinal products for human use in the pharmacy and primary healthcare. With the focus panel method, we analyzed the discussion qualitatively by NVivo 11 Pro. On the focus panel we had five key stakeholders: representatives of the generic industry, the regulator, pharmacy and hospital environment and the innovative industry forum. The results from the project’s quantitative data research showed that introducing a reporting form into the informational system, which is used by health-care workers in routine work, increased the reporting of adverse reactions. Based on the shorter time needed for reporting and active involvement in the project, motivation and pharmacovigilance awareness were increased. Results from the focus panel offered seven determinants of underreporting, which are the foundations for upgrade: knowledge of health-care workers, awareness of health-care workers, lack of motivation of health-care workers, traceability of medicine, time, staff and issues with informational systems. Factors that have a higher priority for solving are: knowledge of health-care workers, awareness of health-care workers and lack of motivation of health-care workers. They are intertwined and by upgrading any one of them, we upgrade the other two at the same time.

• Keywords: adverse reactions, pharmacovigilance system, Slovenia, evaluation and upgrade of the system, factors of underreporting of adverse reactions