Additive manufacturing (AM) techniques, such as drug printing, represent a new engineering approach that can implement the concept of personalized medicine via on-demand manufacturing of dosage forms with individually adjusted doses. Implementation of AM principles, such as pharmacoprinting, will challenge the entire drug distribution chain and affect the society at different levels. Areas covered: This work summarizes the concept of personalized medicine and gives an overview of possibilities for monitoring patients' health. The most recent activities in the field of printing technologies for fabrication of dosage forms and 'polypills' with flexible doses and tailored release profiles are reviewed. Different scenarios for the drug distribution chain with the required adjustments in drug logistics, quality systems and environmental safety are discussed, as well as whether AM will be used for production of on-demand medicine. The impact of such changes in the distribution chain on regulation, healthcare professionals and patients are highlighted. Expert opinion: Drug manufacturing by traditional methods is well-established, but it lacks the possibility for on-demand personalized drug production. With the recent approval of the first printed medicine, society should be prepared for the changes that will follow the introduction of printed pharmaceuticals.

Manufacturing pharmaceuticals by the use of 3D printing is a promising way to achieve more personalized drug treatment. To effectively use this technology, patients need to continuously measure their health, and new decisions have to be taken, for example, regarding the number of daily drugs including how many active pharmaceutical substances these should contain along with decisions around size, shape and color. Positive as well as negative effects of pharmacoprinted medicine on patients are likely to occur. Negative consequences with influence on patient autonomy and role might include: patients not being capable or interested in conducting self-monitoring, loosing overview of the medical treatment, reducing the ability to perform self-regulation, loosing trust in the pharmacoprinted medicine, and not being interested in taking on a new role in medical decision making. These issues are discussed in the paper in order to prevent upcoming challenges in the area of pharmacoprinting.

Sweden had more extensive requirements, probably due to the market being more recently deregulated, while the UK represented a more mature market. There is a difference in the balance between confidence and control, as well as availability and safety when it comes to NPMs in non-pharmacy settings that needs to be further discussed.

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