Future change anticipated to adverse event reporting information to be collected.

FOR INFORMATION ONLY - NO ACTION REQUIRED

Following recent talks with the ABPI Pharmacovigilance Expert Network (PEN), it is likely 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 (2014) for follow up, our 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 2014 EMA guidance can be found within section VI.B.3. Follow-up of reports of the Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1) 8 September 2014 EMA/873138/2011 Rev 1*.

In our meetings with the ABPI PEN the BHBIA Ethics & Compliance Committee have explained the MR implications and raised some issues that will need to be addressed.  We have suggested three possible options (listed below) which are currently out for consultation with the wider PV membership of ABPI.  At this point we just wanted to give let all members know that this is being discussed, particularly as this issue may come up in conversation with PV colleagues.

Further details of what is being considered are as follows:

Likely inclusion of consumer contact data within AE/PC report forms

In the light of the 2014 EMA guidance when information relating to an AE is received directly from a consumer/patient during MR it will be necessary to obtain consent from the consumer/patient to collect and forward their contact data along with the details of the event to the MAH’s PV department for follow up.  Full information as to how the data will be used and who will have access to it, will need to be provided to ensure informed consent.  Individual MAH’s PV departments will determine which events require follow up.

It is anticipated consumers will no longer be asked to provide their HCP’s (as well as their own) contact details in relation to the AE cited.  In the light of data protection requirements for informed consent it is not appropriate for this consent to be obtained by an intermediary (the market researcher) when the user of the data (the MAH) is able and better placed to obtain it.  If HCP details are required for further follow up when the patient/consumer is the reporter, the proposal is that PV will request these directly from the consumer and seek the appropriate consent to follow up with their HCP.

ABPI PEN members consultation

To be fair to all members and all perspectives, ABPI PEN members are being asked for their comments on the three options discussed:

1. "No change - MR agencies continue to request HCP contact details with consent to follow up from the patient and forward to MAH for PV purposes.  No collection of patient contact details"

•  This is very unlikely to be the outcome given EMA guidance.

2. "MR agencies collect patient contact details with patient’s consent for all AE/safety data reports, but only forward the contact details to MAH if requested for PV follow up. This option requires the collection of sensitive personal data by agencies, it will probably reduce the transfer of this information to MAHs but many MAHs require follow up on all forwarded AE/PCs"

• The two part transfer is a concern because of the delays that will be unavoidable and the increased opportunity for mistakes compared to the one step transfer proposed within option 3.

3. "MR agencies collect patient contact details with consent to follow up and forward to MAH PV team for all AE/safety data reports. The MAH PV team initiates follow up with the patient as required and requests authorisation to contact HCP as necessary"

• This was the option preferred by the majority of those involved in the discussions. 

Data protection and privacy implications

As highlighted with the ABPI PEN any change involving the collection of sensitive personal data will have significant data protection and privacy implications.  These will be properly explored and advice provided before any changes are made.

When will the possible change be made?

As the EMA are currently reviewing GVP, changes to the BHBIA/ABPI’s Guidance notes on the collection of adverse events and product complaints from market research programmes (April 2013) and BHBIA’s online training and competency certification programmes will not be put into effect until the EMA’s 2017 revisions are themselves finalised.  This is not likely to be until quarter 4 this year.

Next steps

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

We will keep members informed on this issue but we don’t expect to have any further feedback from the ABPI PEN until May.

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