Fischer, Stefan; Vogler, Sabine (2020): Drug shortages: The situation in four European countries and their approaches to handle the problem. Accepted Abstract. Euhea Conference 2020, 9. Juli 2020, Virtual conference.

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OBJECTIVE: The study aimed to review existing approaches in European countries to prevent and manage drug shortages. *** METHODS: Four countries were selected: Finland, Italy, Netherlands, and Sweden. These countries were considered to be diverse with regard to the financing and organisation of the health care system, though, all were known to struggle with drug shortages. Information was gained through an unsystematic literature search, supplemented by semi-structured interviews with representatives of the public authorities and of community pharmacies in the selected countries. In addition to national statistics, the corresponding products of seven active substances (ranitidine hydrochloride, lamotrigine, hydromorphone hydrochloride, pramipexole dihydrochloride monohydrate, gabapentin, fentanyl, and solifenacin) were investigated, whether they were subject to a shortage in January 2020, or not. *** RESULTS: All four countries implemented an obligatory register for the notification of drug shortages and permit importing foreign medicines in shortage situations. Finland obliges pharmaceutical companies to store defined pharmaceuticals for up to 10 months, whereas the Netherlands will introduce this measure in 2020. In Finland and Italy, authorities may announce an export ban for medicines threatened by a shortage. Furthermore, sanctions - such as fines - apply for pharmaceutical companies for the non-availability of pharmaceuticals selected for the benefits package scheme through tendering processes in the Netherlands and Sweden, or for non-compliance to the obligation to maintain adequate stock supplies in Finland. The notified shortages of the seven active substances differed between countries. Gabapentin was the sole substance that experienced a shortage in all four countries. The other selected substances had a shortage in some, but not all countries, and the non-availability often concerned different products of different manufacturers of the respective active substances. *** DISCUSSION:The research showed that drug shortages in the studied countries had a different extent and affected different products. Furthermore, all countries implemented measures to manage and prevent shortages or planned such activities. A commonly used measure in this respect is a register for notification of shortages which had been introduced as obligatory system in all four countries. A register provides important information to manage shortage situations. Measures to prevent and reduce shortages include mandatory storage systems, export bans and the permission to import medicines. Such measures are usually applied for few medicines, only. However, given the global dimension of this problem, cross-country exchange of information would be a way forward.

Item Type: Conference or Workshop Item (Other)
Subjects: OEBIG > Pharmaoekonomie
Date Deposited: 06 Apr 2021 17:09
Last Modified: 06 Apr 2021 17:09