Adverse drug reactions: Update on Anonymised Single Patient Reports (ASPRs): July 2010

The MHRA has implemented a series of changes to the logic which defines which marketing authorisation holders (MAHs) receive ASPRs/Individual Case Safety Reports (ICSRs). It is expected that these changes will result in a reduction in the number of ASPRs/ICSRs that MAHs receive. The changes are listed below:

• When the suspect drug is reported as a brand name only the MAH that holds that licence(s) for that brand will receive an ASPR/ICSR.
• When the suspect drug is a multiconstituent product (for example, co-codamol) only MAHs that hold a licence for the same combination of actives will receive an ASPR/ICSR.
• When the suspect drug is reported as a single active substance, all MAHs that hold a licence for a product only containing the single active substance will receive an ASPR/ICSR.

The MHRA is also pleased to announce that from 2 August 2010 all ASPRs will be sent out to MAHs electronically.

For MAHs that are currently receiving paper ASPRs:

MAHs that cannot currently receive E2B ICSRs or do not have access to the MHRA portal, an interim arrangement has been implemented. ASPRs will be emailed as PDF documents to the European Qualified Person in Pharmacovigilance (EUQPPV). They can also be emailed to an additional designated email address if required.

Please provide additional designated email addresses to the Pharmacovigilance Service Desk at pharmacovigilanceservice@mhra.gsi.gov.uk.

For MAHs that are currently receiving ASPRS via Portal as PDF documents:

MAHs with an existing MHRA portal account can continue to receive ASPRs via this method. However the MHRA is now encouraging MAHs to move to the receipt of ASPRs as E2B ICSRs.

MAHs ready to start testing the receipt of ASPRs as E2B ICSRs should contact the testing team at ICSRtesting@mhra.gsi.gov.uk. Please note that MAHs who have completed inbound testing with the MHRA will be given highest priority for testing receipt of MHRA ICSRs.