Developing guidelines for the implementation of digitalised technology in pharmacy

Abstract

The pharmaceutical industry is undergoing rapid digital transformation, driven by technological advancements and the need for improved patient care. This study aimed to identify the key risks and opportunities associated with digitalisation across various pharmaceutical ecosystems, including community pharmacy, hospital pharmacy, regulatory affairs, the pharmaceutical industry and clinical practice. The study also aimed to develop guidelines for pharma digitalisation risk reduction. The study involved three main phases. Phase 1 involved a Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis conducted via semi-structured interviews with thirty different stakeholders, representing the five previously mentioned sectors. Phase 2 involved a focus group with five different stakeholders, one from each sector, to evaluate identified threats using a 5x5 risk matrix. Threats were rated based on probability and severity and average Risk Priority Numbers (RPNs) were calculated to prioritise risks. Risk mitigation strategies were proposed, which served as basis for phase 3 of the study involving guideline development. Phase 1 identified numerous benefits of digitalisation, including environmental sustainability (n=30), enhanced communication (n=28), optimisation of resources to enhance efficiency (n=22) and error reduction (n=16). Opportunities identified include artificial intelligence introduction (n=25) and automation (n=22) across different pharmaceutical sectors and the development of a centralised digital healthcare system (n=20). Phase 2 identified several risks such as cybersecurity receiving the highest average RPN score (13.8) during the focus group, followed by regulatory challenges (11.6) and time or training burdens (11.4). Risk mitigation strategies proposed by the focus group participants were used during Phase 3 of this study to develop guidelines. Mitigation strategies suggested included improved IT infrastructure, regulatory updates, staff training and utilisation of user-friendly systems. The study concludes that while digitalisation presents several strengths and opportunities for pharmaceutical innovation, effective implementation requires addressing the associated risks and weaknesses through targeted mitigation strategies. The resulting guidelines developed offer evidence-based, sector-specific recommendations to evaluate the need for digital advancement and support the safe and efficient digital introduction. These guidelines are intended to guide stakeholders, policymakers and institutions in decision making regarding digital integration to ensure technological advancements align with patient safety, data security and regulatory compliance.