Ask anyone in a pharma marketing or regulatory team about the ABPI Code, and they’ll tell you how important it is to stay on the right side of it – particularly when it comes to promotional claims and materials.
But there’s one area that can quietly fall out of step with compliance, despite the best of intentions: prescribing information (PI). Especially the digital kind, found on websites, landing pages and online promotional content.
This is where things can start to unravel.
Despite the ABPI Code and PMCPA guidance being pretty clear, there’s still a persistent myth doing the rounds: that companies have a three-month grace period to update PI in line with changes to the SmPC (Summary of Product Characteristics). Some even think that publishing the latest SmPC alongside outdated PI is a workable stopgap.
It’s not. And the PMCPA has said as much:
“Some companies believe that there is a three-month grace period in which to update prescribing information to reflect changes to the summary of product characteristics (SPC)… Neither of these propositions is true.”
Source: PMCPA
Put simply: PI must be current, accurate, and fully aligned with the latest SPC – at all times. No grace period. No workarounds.
And this applies across every channel, not just printed materials.
Why It Happens: Siloed Teams and Manual Processes
In most pharma companies, responsibility for PI falls into a bit of a grey area. Regulatory might approve the content. Marketing might publish it. Digital might manage the CMS. But no single team oversees the entire lifecycle of PI – especially not once it’s live online.
So what happens?
- The website gets updated with new product messaging, but no one checks the PI.
- A landing page goes live for a new campaign, using a PDF that’s been sitting in SharePoint since last summer.
- A QR code still links to a promotional slide deck with outdated data.
Individually, these might seem like minor slip-ups. But collectively, they put companies at risk of breaching Clauses 12.1 and 12.2 of the ABPI Code, which cover the accuracy and consistency of prescribing information.
And more importantly, they risk eroding trust with HCPs and patients.
So What’s the Fix?
Two things: cross-functional collaboration and smarter processes.
1. Break Down the Silos
ABPI compliance isn’t just “Regulatory’s” problem. It’s something that needs buy-in from:
- Regulatory teams – to ensure content is aligned with the latest SPC
- Marketing teams – to make sure promotional materials are kept in sync
- Digital teams – to manage the actual deployment across online assets
- Medical Affairs – to advise on areas where promotional and non-promotional content blur
Everyone has a role to play. And more importantly, everyone needs visibility of what’s live, where it’s published, and whether it’s up to date.
2. Use Tech That Reduces Manual Error
Manual processes will only take you so far. You can have the best intentions, the best people and still miss something. Which is why a growing number of teams are now turning to tools that help automate parts of the process.
Things like:
- Scanning your site to find outdated PI or SPC mentions
- Flagging potential inconsistencies in product data or indications
- Tracking QR codes and document expiry
- Maintaining a full audit trail for compliance sign-offs
It’s not just about staying compliant. It’s about staying ahead of the curve and making life easier for everyone involved.
From Firefighting to Future-Proofing
Let’s be honest no one likes scrambling to fix an issue after it’s been flagged by Compliance. The goal should be to make PI governance a seamless part of your wider content and approval workflow.
That means better collaboration. Clearer processes. And yes, a bit of automation.
Because accurate, accessible prescribing information isn’t just a regulatory requirement, it’s essential to the safe and effective use of medicines.
Struggling to keep your PI updated across your web estate?
We built PI360 to help pharma teams automate and streamline prescribing information updates, align with the ABPI Code, and eliminate manual errors – without adding more to your to-do list.
Want to see how it works? Book a quick demo.
