Packaging Logistics, Department of Design Sciences, Lund University, Box 118, SE 221 00, Lund, Sweden.
Ther Innov Regul Sci. 2022 Jan;56(1):117-129. doi: 10.1007/s43441-021-00338-0. Epub 2021 Sep 28.
Patient centricity has gained attention ranging from regulatory authorities to patient advocacy groups, calling for pharmaceutical companies to revise their traditional business approach to drug development by including the development of solutions that are meaningful in patients' lives. Medication packaging is one area where empirical evidence is lacking about the incorporation of patient centricity. This study aimed to explore patient centricity applied to pharmaceutical companies' packaging, and to identify the specific challenges faced and lessons learned when developing patient-centered packaging.
The study followed a multiple-case study research approach based on five cases of patient-centered packaging development in mid- and large-sized pharmaceutical companies.
Patient-centered packaging is often associated with the intuitive and self-explanatory use of the medication by patients. Patient-centered packaging comes with challenges, but also offers opportunities for the creation of better solutions for patients and learning for the teams involved. To overcome these challenges, it is essential to build a business case that justifies such development, one where patient needs are present from the start and aligned with other imperative deadlines of drug development, with stakeholders onboard.
Patient-centered packaging is the exception rather than the norm in packaging development due to a conventional approach where packaging plays an ancillary role to drug protection. The cases presented here challenge this approach and can inspire other companies to carry out patient-centered packaging development. The cases are also relevant to other actors who are interested in continuously promoting the dialogue about patient centricity in healthcare.
患者为中心的理念已经引起了监管机构和患者权益组织的关注，呼吁制药公司改变传统的药物开发业务模式，将开发对患者生活有意义的解决方案纳入其中。药物包装是缺乏实证证据的一个领域，证明其纳入了以患者为中心的理念。本研究旨在探讨应用于制药公司包装的以患者为中心的理念，并确定在开发以患者为中心的包装时面临的具体挑战和吸取的经验教训。
该研究采用基于五家中型和大型制药公司的五个以患者为中心的包装开发案例的多案例研究方法。
以患者为中心的包装通常与患者直观和自我解释药物使用有关。以患者为中心的包装带来了挑战，但也为创造更好的患者解决方案和为相关团队提供学习机会提供了机会。为了克服这些挑战，必须建立一个商业案例，证明这种开发是合理的，从一开始就考虑到患者的需求，并与药物开发的其他强制性截止日期保持一致，让利益相关者参与其中。
由于包装在药物保护中发挥辅助作用的传统方法，以患者为中心的包装在包装开发中是例外而不是常态。这里呈现的案例挑战了这种方法，并可以激励其他公司开展以患者为中心的包装开发。这些案例也与其他有兴趣不断推动医疗保健中以患者为中心的对话的利益相关者相关。
