AEMPS Procedure for Reporting Labeling Issues Prone to Medication Errors in Spain

1. Purpose of the Procedure

The Spanish Agency for Medicines and Medical Devices (AEMPS) has established a procedure to receive notifications about aspects of medicine labeling, package leaflets, or technical data sheets that may lead to medication errors. The goal is to protect public health by identifying potential risks early, enabling AEMPS to take regulatory actions with marketing authorization holders to correct issues and prevent incidents.

AEMPS Comunicación de aspectos del etiquetado susceptibles de provocar errores de medicación

2. Types of Issues That May Cause Medication Errors

Common labeling aspects prone to errors include:

• Similar brand names (paronymous medicines).
• Difficult-to-distinguish presentations by dose or administration route (e.g., intramuscular vs. intravenous formulations with similar labeling).
• Poorly visible or confusing text on primary or outer packaging.
• Confusing or limited information in package leaflets for patients or technical data sheets for healthcare professionals.

These issues can result in confusion during prescribing, dispensing, or administration.

AEMPS Comunicación de aspectos del etiquetado susceptibles de provocar errores de medicación

3. Who Can Report and Reporting Process

Notifications can be submitted by healthcare professionals, regional health authorities, professional associations, patient safety organizations, and patients (individually or through consumer groups).

Reports are sent via email to errores.etiquetado@aemps.es. AEMPS reviews all submissions and may issue informative notes or require changes from authorization holders.

AEMPS Comunicación de aspectos del etiquetado susceptibles de provocar errores de medicación

4. Required Information in Notifications

To facilitate evaluation, include:

• Medicine name, pharmaceutical form, registration number, and national code.
• Batch number and expiry date (if applicable).
• Detailed reasons for the potential error.
• Photographs of the involved medicines (recommended).
• Notifier's contact details (name, phone, email).

AEMPS Comunicación de aspectos del etiquetado susceptibles de provocar errores de medicación

5. Evaluation and Actions

AEMPS assesses notifications to determine risks and may coordinate with entities like the Institute for Safe Use of Medicines (ISMP-España) or the Spanish Pharmacovigilance System (SEFV-H). If an error causes harm, it should be reported as an adverse reaction via regional centers or www.notificaRAM.es.

The procedure supports continuous monitoring and rapid intervention.

AEMPS Comunicación de aspectos del etiquetado susceptibles de provocar errores de medicación

6. Legal and Collaborative Framework

This aligns with EU pharmacovigilance regulations (Directive 2010/84/EU, Regulation 1235/2010/EU) and national laws, emphasizing information exchange for safe medicine use.

AEMPS Comunicación de aspectos del etiquetado susceptibles de provocar errores de medicación