The Pharmacy 5.0 framework: A new paradigm to accelerate innovation for large-scale personalized pharmacy care

Annually, millions of patients are adversely affected by nonoptimized medication therapy, resulting in an annual cost of $528 billion in hospitalizations and emergency room and physician visits in 2016 in the US.1-3 Non-optimized medication therapy can manifest during a patient’s journey through healthcare, from inappropriate diagnosis or prescribing to adherence issues or suboptimal therapeutic outcomes, and is a significant health challenge.4 Despite the literature describing issues and solutions, sustained effective solutions have remained elusive. An opportunity exists to address nonoptimized medication therapy and its challenges. Research has focused on segments within a patient’s journey, such as providing the correct medication for a condition, evaluating its effects weeks later, overcoming barriers to adherence, and how providers impact adherence. There has been no overarching integrated framework to connect these segments while cohesively driving innovations in pharmacy. Pharmacy is continually aspiring to transform from the transaction-based business model of dispensing medications to a more interdisciplinary, patient-centric care model.5 The aim of this integrated care model is to improve patients’ quality of care and outcomes with cost-effective and efficient approaches. Personalized pharmacy care requires an in-depth understanding of patients’ needs, accounting for not only socioeconomic factors but also biological, behavioral, and cultural factors. To achieve this goal, the profession must transform from a model heavily weighted toward distribution functions to one focused on enhanced clinical roles, becoming health management centers providing more extensive, integrated, and higher-quality clinical services. Due to recent technological and clinical advances, a paradigm shift and a framework are required to resolve professional and operational challenges.6 The aim is to draw on the industrial revolution and develop similar processes in pharmacy. The Industrial Revolution had 5 phases (Figure 1). Industry 1.0, the first industrial revolution, began in the mid-1700s as machinery, steam, and waterpower were applied to substitute human labor with more efficient machines. Industry 2.0 incorporated electricity and the adoption of assembly line concepts for mass production in the 1870s. Industry 3.0, known as the digital revolution, brought the application of computers, automation, and electronics to increase efficiency and quality beginning around 1970.7 Manufacturing and distribution industries benefited from Industry 4.0 with the use of rapidly evolving technologies such as cyber-physical systems (CPS), the Internet of Things (IoT), artificial intelligence (AI), sensors, and object recognition in creating smart production. The emerging Industry 5.0 phase is embracing human-centric systems, in which human and smart systems work together more effectively and efficiently to maximize quality, service, and personal satisfaction.8 Industry 4.0/5.0 has improved operational efficiency and quality, optimized resource utilization, and created smart production, delivery, and service processes in manufacturing.9 Industrial and pharmacy revolutions from 1.0 to 5.0. AI indicates artificial intelligence; IoT, Internet of Things; 3S, smart medication safety, smart pharmacy, and smart medication adherence and outcomes; 4T, platform, data, analytical, and operation technologies; 5C, cyber-physical systems, data connection, data-information conversion, cognition, and configuration. Icons courtesy of Flaticon.com. Pharmacy has followed a trajectory similar to that of industry (Figure 1). Pharmacy 1.0 greatly reduced workforce requirements for compounding by incorporating machinery. It moved pharmacy from a cottage industry to Pharmacy 2.0 with the mass production of standardized medications.10 This was the birth of modern pharmacy practice. During this time, new practice models and concepts such as unit dose distribution and clinical pharmacy were born. Pharmacy 3.0 brought a digital revolution, including the widespread use of computers and the development of more complex pharmacy systems, operations, and practice sites, all supported by enhanced pharmacy education, including the entry-level doctor of pharmacy degree. Toward the end of Pharmacy 3.0, skills such as medication therapy management, collaborative agreements, and point-of-care testing proliferated. Pharmacy 4.0 applied Industry 4.0 principles to create smart operational systems, such as the applications in smart pharmaceutical operations11-15 and streamlined clinical trials.16 Pharmacy 5.0 involves striving for improved medication safety and quality, enhanced output, reduced pharmacy costs and waste, increased resource optimization, flexible medication production, and other workflow efficiencies by enhancing Pharmacy 4.0 principles through optimizing the interaction between human and smart operational systems. In March 2021, the European Association of Hospital Pharmacists hosted a conference entitled “Hospital Pharmacy 5.0 — the Future of Patient Care.”17 The conference focused on use of digitalization and modern technology, including clinical decision support, to provide the best care for patients. However, discussions surrounding this conference have not yielded a framework. The Pharmacy 5.0 framework is defined as a patient-centric pharmacy care system supported by interprofessional teams, with the adoption of Industry 5.0 principles and concepts, as well as advanced digital technologies including big data, analytics, AI, automation, pharmacogenomics, wearable monitors, and 3D printing of medical devices and medications allowing for highly developed therapy delivery.18-21 The framework supports the adoption of future concepts and developments as well as the expansion and utilization of smart operational excellence methodologies, such as AI and operating systems utilizing Lean Six Sigma, to ensure robust processes. The principles are aimed at accelerating the development and implementation of personalized ways of delivering medications while reducing nonoptimized medication therapy. The framework is intended to support and drive global collaboration and implementation of innovations including development of smart health systems, pharmaceutical and device manufacturers, and distributors. The framework platform offers a new paradigm to enable smart innovations allowing pharmacists to dexterously manage fluctuating workloads, tasks, and resources while improving pharmacy care quality. This will allow more time to personalize pharmacy care while transitioning from primarily procurement and distribution functions to patient-centric health management. The main goals of the Pharmacy 5.0 framework are to Maximize data visibility and integration, medication safety, dispensing quality and efficiency, medication adherence, therapeutic outcomes, essential patient interventions, care team collaboration, and regulatory compliance Minimize prescribing, transcribing, dispensing, and medication administration errors and reduce medication waste, redundant data entry, unplanned disruption in care, time involved in non–non-value-added tasks, and less effective patient interventions Pharmacy care systems are complex and encompass pharmacists’ and providers’ involvement in medication-use systems, diagnostics, and prescribing. These systems incorporate an interdisciplinary approach to ensure proper diagnosis, prescribing, drug use evaluation (DUE), dispensing, monitoring adherence, and treatment outcomes. The medication-use system has some overlap with pharmacy care systems and comprises 6 components: prescribing, transcribing (expanded to include DUE), dispensing, administration, monitoring, and patient education, as proposed by the American Society of Health-System Pharmacists (Figure 2).22 Pharmacy care systems. DUE indicates drug use evaluation. Icons courtesy of Flaticon.com. Prescribing based on accurate diagnosis, laboratory data, treatment guidelines, etc. determines optimal medication therapy and is essential to pharmacy care. The dispensing and distribution functions are how the prescriptions are verified, filled, and delivered to patients. Each step in the medication-use system is error-prone23 and labor-intensive.24 Challenges include risks that potentially compromise health outcomes, operations, and/or utilization of resources. Industry 4.0/5.0 provides context for developing Pharmacy 5.0.25,26 Industry has revolutionized the way companies manufacture, improve, and distribute products. Its processes are powered by CPS and the IoT by incorporating computer-based algorithms to monitor and control components like machinery, robots, and advanced vehicles.27,28 This enables manufacturers to transform into smart automated systems. Additionally, connection with back-end systems, like enterprise resource planning, to enhance the quality of data visibility and control is revolutionary.29 Taking advantage of information analytics and networking systems such as AI, and computer simulation increases the quality, efficiency, and collaboration of operational processes. The resulting algorithms and technologies at each system layer are the foundation for integration within a unified system.30 Industry 5.0 addresses the essential interaction between human and smart automated systems and offers a guide to develop Pharmacy 5.0. An Industry 4.0 framework proposed by Lee9,31,32 serves as the basis for the Pharmacy 5.0 framework. The Industry 4.0 framework includes “5C” functions (CPS, data connection, data-information conversion, cognition, and configuration) and “4T” technology concepts (platform, data, analytical, and operation technologies). The Pharmacy 5.0 framework adds another dimension to Lee’s seminal framework, as it incorporates patients as the central focus by integrating 5C and 4T to achieve the “3S” patient care goals (smart medication safety, smart pharmacy, and smart medication adherence and outcomes) to provide personalized pharmacy care on a large scale (Figure 3). The Pharmacy 5.0 framework, including 5C, 4T, and 3S components. CPS indicates cyber-physical system; IT, information technology; 3S, smart medication safety, smart pharmacy, and smart medication adherence and outcomes; 4T, platform, data, analytical, and operation technologies; 5C, cyber-physical systems, data connection, data-information conversion, cognition, and configuration. CPS provides the environment for managing interconnected systems among patient care systems/devices and associated data. They act as a central hub for cloud data collection, computing and analytics, and operations. CPS enables facile data and information exchange from different systems/devices. The connection function integrates all patient data, including health insurance claims data, clinical guidelines, and clinical decision support tools. Additionally, it integrates consumer-driven technologies like medical wearables, continually updating patient data from multiple sources through aggregation of clinical testing data and multicentered medical records review. Applying the conversion and cognition functions converts mass raw data into meaningful, actionable information displayed in a user-friendly format. This provides a robust, self-adaptive, and self-corrective system capable of integrating clinical decisions in real-time while eliminating hours of non–value-added tasks and increasing accuracy. The configuration function creates a resilient intelligent system through AI and machine learning (ML). This continuous learning aspect of the system and the ongoing input from patients, pharmacists, care providers, and other data sources could generate actionable intelligent recommendations and automatically conduct routine tasks. 5C functions impact not only patient care but also pharmacy operations and medication-use systems by using data from available sources to forecast demand, thereby optimizing pharmacy operations such as inventory management and mitigating shortages. Creating smart pharmacies would enhance supply chain management and staffing to improve efficiency, cost-effectiveness, and resource utilization and optimize patient care. Platform technology conducts CPS function and is the foundation that addresses hardware, storage, IT infrastructure, and cybersecurity. Data technology supports the connection function, which is accurate data collection for reducing manual correction of irregular, missing, and redundant data entry. It is essential in correctly diagnosing, prescribing, and conducting DUE, including assessment of potential drug interactions, medication duplication, previous and potential adverse drug reactions, and adherence to treatment guidelines. Also, data technology enables forecasting for operations, such as inventory, staffing, and scheduling. Analytical technologies, such as AI and computer simulation, convert data to meaningful information to address patients’ health status, diagnosis, and treatment options and enhance clinical decision support tools. Operation technology is applied to create resilient systems with intelligence to automate routine tasks, such as refill reminders, alerts for negative healthcare outcomes, and personalized patient messages. For more effective development and management of smart pharmacy care, the Pharmacy 5.0 framework is designed to achieve patient-centric care aligned with the aforementioned 3S goals: smart medication safety (diagnosis and prescribing), smart pharmacy (operations, logistics, and supply chain), and smart medication adherence and outcomes (patient adherence and treatment outcomes). The framework coordinates a patient’s therapy, allowing agile movement from diagnosis through treatment to optimize therapy, operations, and resources. Currently, many advanced technologies are being used in pharmacy and other healthcare sectors. To enhance the integration of these advanced technologies, a framework is required. One type of advanced automation systems is robots, which are used for routine or tedious tasks such as surgery and medication dispensing.33 Pharmacists use robots in prescription fill systems, yielding a significant decrease in the time to dispense prescriptions.34,35 Saving time on prescription filling allows pharmacists opportunities to increase the quality of care through clinical patient-centric services. 3D printing, a powerful emerging technology, has significant advantages in pharmaceutical manufacturing of personalized dosage forms such as specialty tablets, as seen with levetiracetam in 2015,36 controlled-release dosage forms, and combining medications into a single product.37 Wider use of these technologies would greatly enhance patient outcomes and medication adherence.38 With rapid digital transformation, the development and use of wearable technology has grown.39 Wearable devices can play a role in research and preventive care.40 These devices help track changes in lifestyle.41 They can detect falls and upload information to a healthcare institution for appropriate treatment.42 Wearables can be used in chronic disease management, especially for cardiovascular, endocrine, and respiratory diseases.43 Several diagnostic procedures can be completed with wearable equipment.44 The emerging technologies of the IoT facilitate communication between healthcare providers and patients, decrease healthcare costs, and increase patients’ adherence.45 Recent research shows cancer detection and treatment can be achieved using AI, ML, and IoT-based systems.46-48 Augmented and virtual reality are in use in healthcare. These technologies are useful resources in medical education and training sessions such as surgical procedure simulation.49 Another example is when these systems help patients cope with pain or discomfort.50 The Pharmacy 5.0 framework represents a patient-centric, synergistic care platform aimed at expediting advancement within the field. It facilitates collaborative ventures between pharmacies, healthcare providers, administrators, and technology vendors culminating in the development of smart pharmacy systems that optimize both patient care and operational processes. The aim of this framework is to effectuate a seamless transition from the current patient care paradigm to an information-rich healthcare management system. By establishing the groundwork for an operational and best patient care model, the Pharmacy 5.0 framework harnesses cutting-edge technologies and smart operational excellence, thereby offering a pathway to achieve personalized pharmacy care, on a large scale, that is characterized by heightened organization, precision, efficiency, and efficacy. No new data were generated or analyzed in support of this article. We thank Justin M. Gamble, PharmD, Justin Campbell, PharmD, Dennis Wright, MBA, David Mayhaus, PharmD, Jingyi Wang, MS, PharmD, Victor Warner, PhD, Marianne F. Ivey, PharmD, Dennis Worthen, PhD, Karen Kier, PhD, and Judah Thornewill, PhD, for their thoughtful reviews and feedback on the manuscript of this article. The authors have declared no potential conflicts of interest.