title: Social aspects in additive manufacturing of pharmaceutical products.
abstract: 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.
authors.affiliation: a Department of Pharmacy , University of Copenhagen , Copenhagen , Denmark.
authors.forename: Johanna
authors.initials: J
authors.lastname: Lind
authors.affiliation: a Department of Pharmacy , University of Copenhagen , Copenhagen , Denmark.
authors.forename: Sofia
authors.initials: S
authors.lastname: Kälvemark Sporrong
authors.affiliation: a Department of Pharmacy , University of Copenhagen , Copenhagen , Denmark.
authors.forename: Susanne
authors.initials: S
authors.lastname: Kaae
authors.affiliation: a Department of Pharmacy , University of Copenhagen , Copenhagen , Denmark.
authors.forename: Jukka
authors.initials: J
authors.lastname: Rantanen
authors.affiliation: a Department of Pharmacy , University of Copenhagen , Copenhagen , Denmark.
authors.forename: Natalja
authors.initials: N
authors.lastname: Genina
mesh_terms: D006801:Humans; D004364:Pharmaceutical Preparations; D057285:Precision Medicine; D011327:Printing / Q000379:methods; D012922:Social Change; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D004364:Pharmaceutical Preparations
keywords: Additive manufacturing; continuous monitoring; drug distribution chain; drug regulation; personalized medicine; pharmacoprinting; printing technologies