The management of controlled substances in European hospitals is a complex but critical task. These medicines, while vital for patient care, also pose a high risk of diversion and misuse, especially within hospital environments where access must be tightly regulated. Despite growing awareness, many European hospitals continue to rely on fragmented, paper-based systems, exposing vulnerabilities in security, traceability and efficiency. As the threat of misuse persists, so too does the need for comprehensive digital transformation. Coordinated efforts at both institutional and regulatory levels could enable hospitals to manage controlled substances with greater oversight, ultimately enhancing patient safety and operational resilience.
Fragmented Systems and Regulatory Gaps
Controlled substances management remains constrained by outdated systems and disparate national regulations. Although the EU provides overarching legal frameworks, the implementation of policies differs significantly across Member States. Some countries, like Poland and Spain, have made notable progress with centralised, daily monitoring systems and automated cabinets, while others, such as Sweden and Lithuania, still depend on irregular reporting and manual documentation. This inconsistency hinders real-time oversight and limits effective enforcement of compliance measures.
The survey by the European Health Management Association (EHMA) highlighted significant challenges, including the absence of legal mandates for digitalisation in most Member States. Only six of the sixteen countries surveyed refer explicitly to digital systems in their national legislation. Furthermore, countries like Slovakia only require annual reporting of substance usage, leaving large gaps in monitoring. Without harmonised EU-wide digital standards, the efficacy of oversight mechanisms is diminished and hospitals remain exposed to risks such as theft, unauthorised use and improper disposal.
Operational Challenges at the Institutional Level
Hospitals across Europe face administrative and infrastructural constraints that hamper effective controlled substances management. The EHMA survey revealed that nearly half of pharmacists see registration, administration and dispensing processes as major challenges. Stock reconciliation, documentation and expiry management are additional areas where manual workflows result in duplicated tasks, errors and inconsistencies. Smaller hospitals and under-resourced wards are particularly affected, lacking the tools and workforce needed to ensure secure and compliant handling of these high-risk medications.
The absence of automation and system integration amplifies these challenges. Even in facilities with partial digital tools, critical steps like administration and dispensing still require manual input, creating potential security gaps. Additionally, the lack of coordination among hospital teams, particularly between pharmacists, nurses and doctors, further undermines the implementation of consistent safety protocols. Many pharmacists noted that while they prioritise secure handling, other staff groups may lack the training, resources or capacity to uphold the same standards. Technical limitations, financial constraints and limited legislative authority to introduce changes only compound the problem.
Related Read: Towards Pharmaceutical Resilience in the EU
The Role of Digital Technologies in Transforming Practice
Digital solutions offer a practical and scalable response to these entrenched challenges. The introduction of technologies such as electronic prescribing, barcode medication administration and automated dispensing cabinets can significantly improve traceability and reduce human error. For example, gravimetric systems ensure precise medication compounding, while smart pumps enhance safety in drug administration through dose error reduction features and integration with electronic health records. These technologies create detailed audit trails and support compliance by making all stages of medication management transparent and verifiable.
Controlled substances management software provides a comprehensive framework to automate the documentation process across procurement, storage, administration and disposal. By centralising data, these systems reduce administrative burdens, minimise risk and support real-time oversight. Integration with existing pharmacy and hospital information systems further improves accuracy and efficiency. Moreover, narcotics cabinets and secure medication disposal units are tailored to restrict access and ensure compliance with stringent regulations through biometric authentication, logging mechanisms and real-time inventory tracking.
Despite their potential, the adoption of these technologies remains uneven. Interoperability challenges, outdated hospital IT infrastructure and limited financial support delay implementation. However, support for digital transformation is growing. The EHMA survey indicated that 88% of national regulatory representatives favour digital reporting systems, and 75% are open to legislation mandating digital management in hospitals. These findings suggest that while barriers persist, the momentum for change is building, and there is widespread recognition of the need for coordinated policy action.
The secure and efficient management of controlled substances in European hospitals is essential for maintaining patient safety, regulatory compliance and institutional trust. However, current systems remain inadequate, burdened by administrative complexity, insufficient technology and inconsistent legal frameworks. Smaller hospitals are particularly vulnerable, lacking both the infrastructure and the funding to implement necessary reforms.
A strategic shift towards digitalisation is vital. Integrating advanced technologies into hospital workflows can mitigate risks, streamline operations and enhance security. Regulatory harmonisation across the EU, alongside targeted investments in digital infrastructure and staff training, would provide the foundation for sustained improvements. Sharing successful models among Member States can further accelerate progress and help establish a unified, accountable approach.
Digital transformation in this domain is no longer optional—it is a necessity for safeguarding healthcare systems and protecting public health. Coordinated action at national and European levels is essential to realise these benefits and ensure that all hospitals, regardless of size or resources, are equipped to manage controlled substances effectively and securely.
Source: EHMA
Image Credit: iStock
