Artificial Intelligence (AI) is rapidly transforming various sectors, with healthcare being no exception. For community pharmacies, AI holds the potential to revolutionise everything from inventory management to patient care. However, the adoption of AI comes with significant responsibilities. Recognising this, the European Union introduced the Artificial Intelligence Act (AIA) in 2024. This legislation aims to regulate AI technologies, ensuring they are safe, ethical, and beneficial for society. This article explores the implications of the AIA for community pharmacies, focusing on how it can enhance operational efficiency, patient safety, and regulatory compliance.

 

Background on the Artificial Intelligence Act

The AIA was introduced by the European Parliament and Council to establish a harmonised framework for the deployment of AI technologies across the EU. The act categorises AI systems based on their risk levels — ranging from minimal to unacceptable risk — and imposes strict requirements on high-risk applications, especially in sensitive sectors like healthcare.

The need for such regulation arises from the rapid advancements in AI and the corresponding increase in its adoption across various industries. While AI offers numerous benefits, it also poses significant risks, including bias, privacy concerns, and ethical dilemmas. The AIA aims to mitigate these risks by setting clear guidelines and standards, ensuring AI systems are transparent, accountable, and aligned with EU values.

 

Why the AI Act is needed in healthcare

Healthcare, including community pharmacies, involves handling sensitive patient data and making critical decisions that directly impact patient health. Integrating AI in this sector can lead to substantial improvements in efficiency and care quality. However, it also raises concerns about data security, patient privacy, and the potential for biased decision-making.

The AIA addresses these concerns by:

• Ensuring transparency: Patients and healthcare providers must be informed when AI systems are used, promoting trust and informed decision-making;
• Promoting fairness: AI systems must be designed to avoid biases that could lead to discrimination or unequal treatment; and
• Enhancing data governance: The Act mandates high standards for data quality and protection, ensuring that AI systems operate on accurate and secure data.

 

Implications for community pharmacies

Community pharmacies stand to benefit significantly from the AIA’s regulatory framework. Here’s a detailed look at how the Act impacts various aspects of pharmacy operations:

 

Enhanced operational efficiency

Automation of routine tasks: AI can automate tasks such as inventory management, prescription preparation, and billing. This reduces administrative burdens, allowing pharmacists to focus more on patient care. The AIA ensures these systems are secure and reliable, preventing errors and inefficiencies.

 

Improved supply chain management

AI can significantly enhance supply chain management in community pharmacies by improving demand forecasting, optimising inventory levels, and managing supplier relationships, as outlined below.

Demand forecasting: AI algorithms can analyse historical sales data, seasonal trends, and external factors (such as public health trends or economic conditions) to predict future demand for medications. Accurate demand forecasting leads to:

• Reduced stockouts: Ensuring pharmacies have the necessary medications in stock, thereby improving patient satisfaction and care continuity; and
• Optimised inventory levels: Maintaining optimal inventory levels minimises excess stock, reducing holding costs and waste.

Inventory management: AI systems provide real-time tracking and updates, enhancing inventory management by:

• Automated reordering: Triggering automatic reorders when stock levels fall below a predefined threshold, ensuring continuous availability of medications; and
• Expiry date management: Monitoring expiration dates and prioritising the use or disposal of near-expiry stock, reducing waste and ensuring patient safety.

Improved patient safety and care

Drug interaction alerts: AI tools can provide real-time alerts about potential drug interactions and contraindications, enhancing patient safety. These systems must comply with the AIA’s requirements, ensuring they are accurate and reliable.

Personalised medicine: AI can analyse patient data to suggest personalised medication regimens. The AIA ensures that such AI systems handle data securely and transparently, protecting patient privacy.

Medication adherence: AI-powered reminders and monitoring tools help patients adhere to their medication schedules. These systems must meet the AIA’s standards for transparency and data protection, ensuring patient trust.

 

“Integrating AI in [the pharmacy] sector can lead to substantial improvements in efficiency and care quality. However, it also raises concerns about data security, patient privacy, and the potential for biased decision-making.”  

Compliance and regulation

Data governance: The AIA mandates stringent data governance standards, ensuring the integrity and accuracy of data used in pharmacy operations. This is crucial for maintaining patient confidentiality and trust.

Regulatory oversight: AI systems used in pharmacies will be subject to oversight by notified bodies to ensure compliance with the AIA. This includes regular audits and certification processes, ensuring that AI technologies meet the necessary standards before being deployed.

 

Ethical and legal considerations

Patient consent and transparency: The AIA requires pharmacies to inform patients when AI systems are used in their care. This transparency is crucial for maintaining patient trust and ensuring informed consent.

Bias and fairness: The regulation mandates measures to prevent bias in AI systems. For pharmacies, this means ensuring that AI tools used in patient care do not inadvertently discriminate against certain patient groups, promoting equitable access to healthcare services.

 

Support for community pharmacies

Training and education: Pharmacists will need training to effectively use AI tools. The AIA encourages the development of educational programs to equip healthcare professionals with the necessary skills.

Regulatory guidance: Clear guidelines provided by the AIA will help community pharmacies understand their obligations and the capabilities of AI systems, ensuring they can make informed decisions about adopting new technologies.

 

How vendors might use AI to enhance their systems

Beyond compliance with the AIA, pharmacy system vendors can leverage AI to enhance their systems and offer practical solutions to community pharmacies. Here are some ways they might do this:

• Advanced analytics for decision making: Vendors can integrate AI-powered analytics tools to provide pharmacists with actionable insights. For instance, predictive analytics can identify trends in medication usage, helping pharmacists make informed decisions about stocking and managing their inventory;
• Patient engagement tools: AI can be used to develop chatbots and virtual assistants that engage with patients, answering queries, providing medication information, and sending reminders for prescription refills. These tools can enhance patient interaction and improve adherence to treatment plans;
• Personalised health recommendations: AI systems can analyse patient data to provide personalised health recommendations, such as lifestyle changes or preventive measures, tailored to individual patient needs. This can enhance patient care and support the role of pharmacies in promoting overall health and wellness;
• Enhanced security features: AI can be used to develop advanced security features, such as real-time fraud detection and prevention systems, ensuring the safety and integrity of patient data. This is crucial for maintaining trust and compliance with data protection regulations;
• Optimised workflow management: AI can streamline pharmacy workflows by automating routine tasks and optimising resource allocation. For example, AI-powered scheduling systems can manage staff shifts and appointments more efficiently, ensuring optimal use of time and resources; and
• Integrated health platforms: Vendors can develop AI-integrated platforms that connect various aspects of healthcare delivery, from patient records to supply chain management. This holistic approach can improve coordination and collaboration between different healthcare providers, leading to better patient outcomes.

 

Compliance with the AIA

Pharmacy system vendors and suppliers have a responsibility with implementation of their AI technologies in compliance with the AIA:

• Developing compliant AI solutions: Vendors must ensure that their AI solutions meet the stringent requirements of the AIA, including data governance, transparency, and bias prevention. This involves rigorous testing and validation processes to certify their products;
• Providing training and support: Vendors should offer comprehensive training programmes for pharmacists and other healthcare professionals, ensuring they are equipped to use AI tools effectively and understand the regulatory requirements;
• Ensuring interoperability: AI systems should be designed to seamlessly integrate with existing pharmacy management systems and electronic health records (EHRs). This ensures smooth adoption and maximises the benefits of AI technologies;
• Continuous improvement and updates: Vendors should commit to ongoing research and development, regularly updating their AI solutions to incorporate the latest advancements and ensure continued compliance with evolving regulations; and
• Customer feedback and collaboration: Engaging with pharmacists and end-users to gather feedback and collaborate on product improvements is essential. This helps vendors understand the practical challenges faced by pharmacies and develop solutions that address their specific needs.

 

Implementation in Ireland

The Artificial Intelligence Act will be enacted in Ireland starting January 2025. The implementation will follow a phased approach to allow businesses and organisations, including community pharmacies, to adapt to the new regulations. The initial phase will focus on high-risk AI applications, with mandatory compliance and certification processes being introduced. Subsequent phases will expand to cover additional aspects of AI deployment, ensuring a comprehensive regulatory framework by the end of 2025.

In Ireland, the implementation and enforcement of the AIA will be overseen by several key authorities:

1. Department of Enterprise, Trade and Employment: This Department is responsible for the overall policy and regulatory framework related to technology and innovation in Ireland. They will play a significant role in the adoption and monitoring of the AIA within the country;
2. Data Protection Commission (DPC): Given the emphasis on data governance and protection in the AIA, the DPC will be crucial in ensuring compliance with data protection standards and addressing any breaches or violations related to AI technologies;
3. Health Products Regulatory Authority (HPRA): For AI applications in healthcare, including community pharmacies, the HPRA will oversee the compliance of these systems with the AIA’s requirements, ensuring they meet safety and ethical standards; and
4. AI Advisory Council: This newly formed Council will provide guidance, support, and oversight on the implementation of the AIA in Ireland. It will work with various stakeholders, including government bodies, industry representatives, and academic experts, to ensure the effective regulation of AI technologies.

These authorities will collaborate to ensure that the AIA is effectively implemented and that AI systems in Ireland adhere to the highest standards of safety, transparency, and accountability.

 

Conclusion

The AIA represents a significant step forward in ensuring that AI technologies are used responsibly and effectively in community pharmacies. By enhancing operational efficiency, improving patient safety, and ensuring regulatory compliance, the act provides a robust framework for the integration of AI in healthcare.