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5 Areas in Adverse Event Reporting to Consider

Traditionally, sources of adverse event reporting included the clinical trial investigator sites, post-marketing medical information call centers, and local QPs in Europe. However, currently, potential adverse event reporting is occurring outside of these traditional modalities.

Below, I have provided insight into ensuring AEs are being monitored and captured properly, regardless of their source. Here are a few points to keep in mind:

  • Non-Traditional AE Reporting

More than ever, AEs are being reported from non-traditional sources including product websites, social media, and sites of care.  You must have documented safety reporting plans and training in place.


  • Patient Interaction Programs – Do they meet the necessary requirements?

Manufacturers are providing additional patient support options for their products. Common Patient Interaction Programs include: specialty pharmacies, patient assistance programs (PAPs), pharmacy benefit managers (PBM), REMS KAB and other surveys, reimbursement Hubs, medication/patient adherence services, and market research programs. The Pharmacovigilance team needs to be kept abreast of the implementation of such programs and a system for reporting needs to be determined. Both the FDA and the MHRA are looking closely at the above AE reporting processes during inspections.  A review of sample audits found multiple instances of a citation for lack of training and documentation related to AEs for patient interaction settings.


  • Training documentation

Patient Interaction Programs staff may be aware of AE reporting, but many do not understand all required reporting. It is your responsibility as the Marketing Authorization Holder (MAH) to ensure documented training has taken place for all patient interaction programs and staff.


  • Ongoing monitoring

Monitoring is key. You should be aware of programs being conducted, ensure documented SOPs are in place for AE capture and triage, and ensure vendor contracts and master service agreements have a safety reporting provision.


  • Audits mitigate risk

Audits of these programs and sites can and should be used to help mitigate the risk of unreported AEs and to demonstrate vendor oversight.

A patient reports an adverse event

As experts in Pharmacovigilance, UBC understands Product safety. For more information on our Pharmacovigilance services or to speak with one of our experts, please click here, and a member of my team would be happy to assist in ensuring the proper oversight is in place for all of your adverse event reporting.