Future change to adverse event reporting information to be collected - latest update - FOR INFORMATION ONLY - NO ACTION REQUIRED

It's been a while since we announced the expectation of future changes and some members have been asking about whether there is any further news of when implementation is expected.

Here's the latest update:

Background

Following talks with the ABPI Pharmacovigilance Expert Network (PEN) in 2017, it's been agreed that we will need to change the BHBIA adverse event/product complaint reporting guidance when AEs are collected directly from patients or consumers. 

To meet their EMA obligations for follow up, our pharmacovigilance (PV) colleagues need to collect sufficient information to enable them to follow up with the patient/consumer that reported the event and still meet data protection requirements.  The latest (2017) EMA guidance can be found within section VI.B.3. of the Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products.

What this means for market researchers is that we will need to change the guidance so that, when AEs are collected directly from patients or consumers, we'll need to collect the patient/consumer’s contact details and record their consent to forward details to the MAH PV team for all AE/safety data reports. This will allow the PV team, if necessary, to follow up with the patient/consumer that reported the event and request authorisation from the patient to contact their HCP if needed.

Data protection and privacy implications

Clearly this change is not a ‘quick fix’ as there are significant data protection and privacy implications – any change involving the collection of sensitive personal data needs to be properly explored and advice provided before any changes are made.

Next steps

Over the next few months we will be:

• Working closely with the ABPI to develop the new guidance and consulting with the ICO to examine the associated data protection and privacy issues that will need to be addressed;
• Updating the BHBIA/ABPI’s Guidance notes on the collection of adverse events and product complaints from market research programmes - we’ll also be taking this opportunity to produce a more user-friendly version;
• Planning associated changes to the BHBIA’s online training and competency certification, plus updates to materials such as the Data Collection Form and other resources.

We will keep members informed on this issue but for the time-being you should continue to follow the current guidance. 

If you have any questions or comments, please email us at admin@bhbia.org.uk

View the current BHBIA/ABPI’s Guidance notes on the collection of adverse events and product complaints from market research programmes.