Project for Elimination of Paper Package Inserts for Hospital Medicines in Spain

Project Background and Objectives

AEMPS initiated a structured project to suppress paper package inserts (prospectos) for medicines exclusively intended for hospital use. The main goals include:

• Reducing paper consumption and environmental footprint in healthcare settings.
• Facilitating faster and more reliable access to up-to-date product information.
• Enhancing efficiency in hospital pharmacy workflows.
• Maintaining or improving patient and healthcare professional safety through digital alternatives.

This initiative aligns with EU trends toward digitalisation of medicinal product information and sustainability objectives. Proyecto para la supresión del prospecto en papel en los medicamentos de uso humano de ámbito hospitalario - AEMPS

Scope of Application

The project targets medicines authorised exclusively for hospital use (those with “Uso hospitalario” or “Uso hospitalario exclusivo” in their authorisation conditions). It excludes:

• Medicines for outpatient or community pharmacy dispensing.
• Products where paper inserts remain legally required (e.g., certain high-risk or special-need medicines during transition).

Participating products are identified by their national code and marketing authorisation status.

Implementation Phases and Timeline

The transition is phased:

• Phase 1 (Pilot): Voluntary participation by selected marketing authorisation holders to test processes and technical solutions.
• Phase 2 (Mandatory progressive suppression): Gradual elimination of paper inserts for hospital-only medicines, with deadlines set per authorisation or therapeutic group.
• Full digitalisation: Paper inserts fully replaced by electronic versions for qualifying products.

Exact timelines and inclusion lists are published and updated on the AEMPS website as the project advances.

Digital Alternatives and Access Methods

Once paper inserts are suppressed:

• Electronic Package Insert: Available in real time via the AEMPS CIMA database (online searchable platform).
• DataMatrix Code: Printed on the immediate packaging or outer carton, allowing instant access to the current electronic insert using a smartphone or hospital scanner.
• Hospital Systems Integration: Encouraged linkage with electronic prescribing and pharmacy systems for seamless access.

Marketing authorisation holders must ensure the electronic version is always current and matches the authorised text.

Safeguards and Support Measures

To ensure safety during transition:

• Healthcare professionals receive training and guidance on accessing digital information.
• Dual systems (paper + digital) may be maintained temporarily for high-risk products.
• AEMPS monitors implementation, collects feedback, and may adjust timelines or requirements.
• Patients and professionals can report difficulties via official channels.

This project represents a significant step toward sustainable, modernised information provision for hospital medicines in Spain while preserving high standards of safety and traceability. Detailed project documents, participating products, technical specifications, and progress updates are available on the AEMPS dedicated project page. Proyecto para la supresión del prospecto en papel en los medicamentos de uso humano de ámbito hospitalario - AEMPS