Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Safety Labelling Implementation - a Challenge for Marketing Authorisation Holders and an Opportunity through ePI to increase Patient Safety ***

Anna Sobek (Abschlußjahr: 2022)

Summary
Language: English
The marketing authorisation holder (MAH) is obliged under EU and national law to keep the product information texts up to date with the latest scientific knowledge at all times. Keeping product information texts up to date is a continuous process as the risk-benefit balance of medicinal products can change regularly.
Safety Labelling is the information in the product information texts that is related to the safety and efficacy of a medicinal product used within the scope of its authorised use.
The production and packaging of medicinal products is a very complex process involving many different stakeholders and requiring sufficient lead times.
Changes to safety-relevant sections of the product information texts affect the safety of the medicinal product and should therefore be implemented as soon as possible in production in order to inform patients and healthcare professionals (HCPs) immediately of any changes to the risk-benefit balance. In practice, the MAH often encounters difficulties in the timely implementation of changes of the printed product information texts. Production delays and product recalls occur repeatedly, which in turn can lead to supply shortages that may jeopardise patient safety.
In a world where digitalisation is on the rise in all areas of life, the idea of electronic product information (ePI) is becoming increasingly important in the healthcare sector as well.
The objective of this thesis is to describe and analyse the challenges of the safety labelling implementation and investigate whether the successful implementation of ePI could speed up the process of implementation and make a contribution to increase patient safety.
The organisation of MAH and partners plays an important role in the challenges, as do production processes, production frequency, production volumes and price pressure on medicinal products. There are already plenty of reasons for supply shortages of medicines, so problems with timely implementation should not become an additional reason.
One of the main problems with implementation is that there is no harmonised approach to implementation timelines in the EU. Implementation timelines are interpreted differently depending on the country or local state authority in Germany, so a welcome development would be to harmonise approaches and give the MAH more room for implementation timelines to ensure patient supply.
With the introduction of ePI a very large, complex and, above all, time-consuming task lies ahead of MAH and regulators which will, however, result in an optimisation of various regulatory processes in the long term. The benefits and disadvantages of ePI implementation for patients/HCPs/regulators are discussed in relation to the practical aspects of ePI implementation, safety labelling implementation and patient safety. With the introduction of ePI, it makes sense to waive the obligation for the MAH to include a physical package leaflet in the packaging, as this is the only way to completely solve the problem of safety labelling implementation. Nevertheless, even if the obligation is maintained, the inclusion of a QR code in the package leaflet linking the current ePI could be a relief for the MAH as its legal liability would be met and the updated information about the medicinal product could reach patients/HCPs faster without compromising patient safety.
Finally, it is concluded that the successful implementation of ePI could solve the problem of safety labelling implementation and that ePI will contribute greatly to increasing patient safety, by enhancing the patient experience and by avoiding supply shortages due to production delays caused by updates of product information texts.
Pages: 63