5 Top Tips for Compliant Patient Information Leaflets (PILs)

Article By Vicki Pike, EPiC Operations Manager

Errors in Patient Information Leaflets (PILs) and outdated leaflets are among the leading causes of defect notices in the UK. These issues often involve not implementing safety warnings within the required timeframe. Such failures not only compromise compliance but can put patient safety at risk.

Based on best practices and regulatory expectations, here are five top tips every pharmaceutical company should adopt to prevent these costly and dangerous errors.

Best practices for Compliant Patient Information Leaflets (PILs)

1. Implement a Robust Change Control Process

Every update to registered text or artwork should be managed under a formal change management process. This process should:

Identify all impacted SKUs, components, and markets to ensure no omissions.
Track regulatory approvals and timelines for implementation.
Coordinate actions across stakeholders, including Regulatory, Pharmacovigilance (PV), Packaging Departments, and Quality.

A standardised template can be used for artwork changes to prompt for the required actions and reduce oversight risks.

Safety Update Focus: For priority safety changes, timelines are usually three months. Your change control system should flag these as high-risk and escalate them for expedited handling.

2. Ensure Version Control and Accurate Proof Checks

To prevent artwork errors during updates:

Assign unique codes or version numbers to each updated artwork.
Proof-check updated artwork against the approved master text. This can be performed manually under controlled conditions (appropriate lighting, minimal distractions) or using validated Optical Character Verification (OCV) systems.
Ensure translations are accurate. These should be performed by bilingual professionals familiar with medical terminology.

3. Communicate Implementation Dates Clearly

The Qualified Person (QP) must know the exact date after which old components cannot be used. To achieve this:

Confirm the implementation date, based on the market supplied. Typically for UK/EU, implementation date is 3-6 months after Regulatory Agency approval.
Communicate implementation dates across the supply chain, especially to the QP.
Update Bills of Material (BOM) to block old components after the grace period (typically 3–6 months).
Monitor stock levels and lead times to avoid last-minute non-compliance.

Safety Update Focus: For urgent safety updates, regulators may require immediate implementation. Your system should allow for rapid cutover and prevent QP certification of outdated packs.

4. Strengthen Supplier and Packaging Site Controls

Errors can originate at suppliers or during packaging. Key control measures include:

Audit printed component suppliers for compliance with relevant GMP standards (e.g., PS9000:2016). Check processes for version control, archiving superseded artworks and line clearance.
Packaging sites must have robust processes for line clearance, in process controls and printed component reconciliation.
Use electronic code readers correctly – they must be set using independent references, not samples from delivered stock.

5. Achieve End-to-End Visibility and Stakeholder Engagement

Break down silos between Regulatory, PV, and Manufacturing. Ensure:

PV QP receives confirmation of artwork implementation.
Contract packaging sites are informed of changes.
All impacted markets and components are identified early.
Metrics track the entire process—from regulatory approval to implementation in packs, not just individual steps.

Safety Update Focus: Establish a dashboard or KPI system that monitors compliance with safety update timelines across all SKUs.

Bonus Tip: Prepare for the Future with Electronic Product Information (ePI)

Electronic Product Information (ePI) offers a promising solution to many root causes of PIL errors. By enabling real-time updates and digital access, ePI can eliminate outdated leaflets and improve patient safety. While legislative changes are required before paper PILs can be removed, companies should start exploring ePI readiness now.

Final Thoughts

Incorrect or outdated PILs pose a significant patient safety risk.By implementing these controls and prioritising safety updates, pharmaceutical companies can significantly reduce recall risks and ensure their commitment to patient care.

Get in touch if you would like to find out more about how our integrated approach utilising PV and GMP expertise can help you achieve end-to end-compliant systems for implementing safety warnings and protect patients.