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Short abstract:

We provide an overview of the advantages and disadvantages of pharmacy compounding as an alternative medicine-to-patient route. We present a preliminary qualitative analysis based on documents about Dutch compounding initiatives and interviews about scenarios of a compounding device (Nanospresso).

Long abstract:

Historically, pharmacy preparation (compounding) has been used to prepare drugs, dosages, or formulations that industry cannot provide. However, recently, it has been proposed to use compounding, instead of marketing authorization, as an alternative medicine-to-patient route for newly developed personalized medicines for orphan indications. The barriers for bringing orphan drugs to the market are often high, especially when these drugs are developed in hospital or academia. This results in decreased patient access. Additionally, the current regulatory system provides barriers for personalized medicines, which need to be produced locally and adapted to individual patients. Pharmacy compounding could provide a solution.

Currently, a device (Nanospresso) is being developed with the intention of enabling the local bedside production of personalized nucleic acid therapies, potentially achieved via compounding. The development of the Nanospresso device gives rise to several questions regarding the boundaries of pharmacy compounding as an alternative route towards patient access. This paper explores the feasibility and desirability of the local pharmacy preparation of personalized complex pharmaceuticals.

We aim to provide an overview of the advantages and disadvantages of using this alternative access pathway, focusing on technical, practical, legal, ethical, regulatory, social and monetary aspects. To create this overview, we will analyze scientific literature, newspaper articles, and government documentation about recent Dutch compounding initiatives. In addition, we will conduct interviews with stakeholders in the Dutch compounding debate where we present people with different scenarios of a compounding device for the bedside production of individualized medicines (Nanospresso). At EASST we will present our preliminary results.