If you haven’t heard about the pharmacovigilance legislation changes in Europe, you must have been living on Mars. Come to think of it, I bet that Curiosity rover on Mars knows about it too, after all it tweets!
If you work in PV, then you are in that washing machine world where you are tumbled back & forwards, periodically spun at high speed than stopped dead.
So what do Med Info folks need to know about how the changes affect them? After listening to superb presentations from a QPPV for a major company and, more recently, from Cleo Fu, Alliance Pharmaceuticals at the PIPA First Steps in Pharmacovigilance training day, I’ve got a better sense of what’s changed/changing for us in Med Info.
And to make it easier for you, I’ve clarified what aspect of MI I think is affected plus the change itself (and they are my personal reflections – I could be wrong…):
- Operations & Query Handling Patients can now report adverse events in all European countries signed up to the legislation. This has been going for a while in the UK and some other European countries but now the scheme is/will be extended to all countries. CALL TO ACTION 1) You can encourage a customer to report their AE themselves, as well as to go see their doctor/pharmacists/nurse etc. 2) Will you still need to get the HCP details to medically confirm the AE, especially if the person is reluctant to go see their doctor etc?
- Operations/Resource Adverse events due to off-label use, misuse, overdose, lack of effect, medication misuse etc have come under closer scrutiny. CALL TO ACTION 1) If a customer asks about off-label use, will you have to routinely ask if there is a particular patient in mind and have their experienced an AE? This means more time on these queries and more reporting/logging details
- Audit Audit findings are now included in the PSMF (Pharmacovigilance System Master File) so those unpleasant findings are now visible to inspectors. CALL TO ACTION 1) Are you confident that all your MI procedures, documentation and personnel meet regulations?
- Competitor Intelligence Risk Management Plans (RMP) will become visible to the public for centrally authorised products. Which means you get to look at your competitors RMP but they can get to see yours! CALL TO ACTION 1) One to watch! As time goes by, more product RMP will become visible.
- Operations/Resource All non-serious AEs are now reportable <90days) so there are more AEs to report & more time/resource needed to collect the data. CALL TO ACTION 1) do you have the capacity? 2) Do you have the data to calculate the possible/probably impact if MI people collect & log AE details for spontaneous adverse events.
- Operations/Resource First, the good news: The EMA are scanning literature sources for AEs to avoid duplication. But the bad news: you will still need to scan literature as you need to include cases in your PSUR and signal detection processes.
- Standard Responses A scheme similar to the UK Black Triangle warning will be used to alert prescribers to intensive safety monitoring for some medicines. CALL TO ACTION 1) Will you need to update your standard responses used in the EU to add the warnings, if they don’t have them already?
- Sources/Competitive Intelligence The Medicines Portal will give greater transparency to patients and prescribers alike by including the RMP and prescribing information. The MHRA is now adding SPCs to their website but colleagues have told me it’s worth checking that they have the right version. CALL TO ACTION 1) Another source to suggest to people wanting access to SPCs & PILS, including ourselves!
The EMA are still putting out more Good Pharmacovigilance Practice modules so watch out more guidance on what we need to do. But better still, make sure you are best friends with your Drug Safety & Pharmacovigilance colleagues so they keep you up to date. After all, they need you to make sure they are compliant and continue to protect patients!