Adverse Event Reporting - Are You Compliant?

Adverse Event Reporting - Are You Compliant?

As the drug safety landscape shifts, so do the methods for AE reporting. Traditional sources of adverse event reporting include clinical trial investigator site and post marketing medical information call center.  However, potential adverse event reporting can occur in any patient interaction program, such as specialty pharmacies, patient assistance programs, and patient adherence services.  Because capturing drug safety information is paramount, I chose this topic for my presentation at last week’s HNC U.S. Drug Safety Congress. In my discussion, I shared a snapshot of the current landscape and provided insights on ways we can ensure AEs are being monitored and captured properly.  Here are a few points to keep in mind:

 

  • 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.
     
  • More than ever, AEs are being reported from non-traditional sources including product websites, social media, and sites of care .
     
  • Both the FDA and the MHRA are looking for proper adverse event reporting. A review of sample audits found several instances of citation for lack of training and documentation related to AEs for patient interaction programs.
     
  • 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 within all centers.
     
  • 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 can and should be used to help mitigate the risk of unreported AEs.

As experts in Pharmacovigilance and part of a company that manages both Hubs and PAPs, UBC understands drug safety. If you are in need of guidance, please contact me. My team would be happy to assist in ensuring the proper oversight is in place for your all safety reporting.