Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Drug Shortage - A complex global challenge. Recent developments in the EU, industrial aspects with a special focus on Austria and an idea of international handling via a global portal ***

Anna Rubik (Abschlußjahr: 2021)

Summary
Language: English
Currently not available is the answer heard more and more often by patients and physicians seeking medicinal products, and it is an issue of increasing importance. Handling the challenge of drug shortages has become a daily task for the pharmaceutical industry.
In this thesis, the topic of drug shortages in the EU is discussed, with a special focus on Austria. The progress made by the "Task Force on availability of authorised medicines for human and veterinary use" has been incorporated into this thesis. This task force provides strategic support and advice for coordination in the EU with a focus on drug availability and shortages. One step taken by the task force to address the issue of drug shortages in the EU was the establishment of thematic working groups. The thematic working groups were structured to address the following aspects of drug shortages: marketing authorisations, supply chain, and communication. The working groups developed a definition of the term "drug shortage" and also compiled guidance for Marketing Authorisation Holders. Additionally, the groups defined the general reporting responsibilities of marketing authorisation holders and set timelines for notification of drug shortages. The group also developed a template for these notifications.
This thesis also considers some of the possible causes of drug shortages and unavailability. These include manufacturing practices, supply-chain issues, Brexit, company mergers and parallel distribution. Additionally, this thesis briefly discusses the effect of unexpected events on drug availability. To illustrate this issue, this thesis considers the 2020 COVID-19 pandemic, which initially resulted in medicinal product export bans and production site shut downs. Later, after the authorisation of vaccines, a further issue arose when a contracted number of dose units was reduced due remodelling at the filling plant. The thesis also briefly discusses the Heparin drug shortage that resulted from the African Swine Fever and the problem of Nitrosamine-impurities. As demonstrated in this thesis, the problems that lead to drug shortages are complex and varied.
Based on this, "expert interviews" were performed with a qualitative outcome in order to get feedback on the daily handling and business of drug shortages. For this purpose, colleagues working in different pharmaceutical industry sectors were selected for interviews, with questions based on previous discussions and literature review. The interview partners are from the pharmaceutical industry, acting as a marketing authorisation holder (MAH), a wholesaler, a physician and a manufacturer. As this thesis focuses on Austria, interviews with MAHs were included. These interviews reveal information about the daily handling of drug shortages. Questions about the location of production sites of the active product ingredient and the finished product were included. Answers to these questions showed that on average 53% of the API production of the interview partners’ companies is manufactured in the EU, while on average 82% of the FP production is manufactured in the EU. This thesis also found that fast and/or short term increases to production capacity is difficult and even in some cases, not possible, due to the required production site lead times. Finally, many of the interview partners indicated a desire for better notifications with regard to drug shortages and stated that these notifications should include any unavailabilities of any competitor products.
This thesis includes a concept for a global portal created using the structured design method to describe the system architecture. This global portal is designed as a module that could be integrated into already existing databases, such as SPOR and other national health authority databases. Issues with regard to data entry and direct cooperation with existing databases are considered. The aim of this global portal is to make it easier for its users to share work, assess potential and actual shortages (via the connection of existing national databases so that drug supply data is automatically updated), and to provide a place where direct communication between stakeholders can occur. If this global portal system were implemented marketing authorisation holders could, in only one step, notify all concerned countries, thus avoiding separate national submissions.
Pages: 68