This document is an official guideline from the EMA, finalized in October 2015. Its primary purpose is to provide standardized, clear instructions for all stakeholders in the European Union (EU) on how to handle medication errors within the pharmacovigilance (drug safety monitoring) system. The goal is to improve public health by ensuring consistent recording, coding, reporting, and assessment of these errors, which facilitates learning and prevention.
Key Sections Explained
1. Introduction & Scope
- Problem: Medication errors are a significant public health burden, causing a large percentage of preventable adverse events in hospitals.
- Goal: The guide was created to support the implementation of new EU pharmacovigilance legislation related to medication errors.
- Scope: It applies to errors with medicinal products authorized in the EU that are associated with a suspected adverse reaction (harm). It is mandatory for National Competent Authorities (NCAs), Marketing Authorisation Holders (MAHs), and the EMA.
- What’s Included: It also provides recommendations for recording and assessing medication errors without an adverse reaction, which must be summarized in Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
- What’s Excluded: Errors occurring in clinical trials, and events related to intentional overdose, abuse, misuse, and occupational exposure are outside its scope.
2. Definitions (Crucial for Understanding)
The guide provides precise definitions to ensure a common understanding:
- Adverse Reaction (ADR): A noxious and unintended response to a medicinal product. This includes reactions arising from medication errors and uses outside the marketing authorisation (e.g., overdose, misuse).
- Medication Error: An unintended failure in the drug treatment process (prescribing, storing, dispensing, preparing, administering) that leads to, or has the potential to lead to, harm to the patient. It is clearly distinguished from intentional acts like misuse or abuse.
- Classification of Medication Errors:
- Error with ADR: An error occurred, reached the patient, and caused harm.
- Error without Harm: An error occurred and reached the patient, but no harm was detected.
- Intercepted Error (‘Near Miss’): An error occurred but was caught and corrected before it reached the patient.
- Potential Error: A circumstance is identified that could lead to an error, but no error has actually occurred (e.g., two drug packages look very similar).
3. Structure and Processes (The “How-To” Core)
A. Recording
- Medication errors with an associated adverse reaction must be recorded as a valid Individual Case Safety Report (ICSR) in the pharmacovigilance database.
- Errors without an adverse reaction (including intercepted and potential errors) should also be recorded by MAHs, but not reported as ICSRs. They are used for analysis and summary in PSURs and RMPs.
- Collaboration between national pharmacovigilance centers and Patient Safety Organisations (PSOs) is encouraged to share information.
B. Coding
- The Medical Dictionary for Regulatory Activities (MedDRA) is the mandatory terminology for coding.
- The guide provides detailed principles:
- Code only what is stated in the report; do not infer an error.
- Select the most specific MedDRA term for both the error (e.g., “Wrong drug administered”) and the adverse reaction (e.g., “Hypotension”).
- It clarifies how to distinguish medication errors from related concepts like off-label use, misuse, overdose, and product quality issues.
C. Reporting Requirements
- For errors WITH an adverse reaction: These must be reported as ICSRs to EudraVigilance (the EU database for suspected ADRs) by both MAHs and NCAs, following standard timelines.
- For errors WITHOUT an adverse reaction: These are not to be reported as ICSRs. Instead, their patterns and analysis must be summarized in the PSUR and RMP.
- Special Cases:
- Name Confusion: Errors related to confusing drug names should be reported to the EMA’s Name Review Group.
- Emerging Safety Issue: A medication error that significantly impacts the benefit-risk balance of a drug must be reported immediately as an emerging safety issue.
D. Follow-up
- Reports should be followed up to get as much information as possible.
- Key parameters to investigate include:
- The stage of the medication process where the error occurred (e.g., prescribing, administration).
- Contributing factors (e.g., human factors like fatigue, system factors like workload).
- Patient factors (e.g., paediatric, elderly).
- Mitigating/Ameliorating factors (actions taken to prevent or correct the error).
4. Operation of the EU Regulatory Network (Stakeholder Roles)
- National Competent Authorities (NCAs): Responsible for collecting, recording, and reporting ICSRs related to medication errors. They should collaborate with national PSOs.
- Marketing Authorisation Holders (MAHs): Legally obligated to record, report, and assess all medication errors brought to their attention. They must include analysis in PSURs and RMPs and implement risk minimization measures.
- PRAC (Pharmacovigilance Risk Assessment Committee): The EMA committee responsible for assessing all pharmacovigilance data, including medication errors, and recommending regulatory actions.
- Healthcare Professionals (HCPs) and Patients/Consumers: Encouraged to report any suspected adverse reactions, including those resulting from errors, to their NCA or the MAH. Their reports are a critical source of information.
5. Annexes (Practical Tools)
The guide includes practical templates and examples:
- Annex 1: A diagram of the reporting workflow after the EudraVigilance audit.
- Annex 2: Templates for summary tables and listings of individual cases for PSURs and RMPs.
- Annex 3: Extensive coding examples for different types of medication errors (with and without harm, accidental exposures, device errors, etc.).
- Annex 4: A technical business process for using the ICH E2B (R3) electronic standard to “flag” a drug involved in a medication error within an ICSR.
Summary
In essence, this guide establishes a unified EU system for managing medication errors. It mandates the reporting of errors that cause harm, promotes the recording and analysis of all errors (even those that don’t cause harm) for learning purposes, and provides detailed technical instructions on coding and reporting to ensure consistency across member states and pharmaceutical companies. The ultimate aim is to proactively identify risks and prevent medication errors from happening again, thereby enhancing patient safety.
