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5 Areas in Adverse Event Reporting to Consider

Discover non-traditional areas that could be critical for your safety responsibilities.
Discover where to look for outside of traditional AE reporting.

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 is some insight, 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.

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 our team would be happy to assist in ensuring the proper oversight is in place for all of your adverse event reporting.

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Bekki Bracken Brown

President & Chief Executive Officer

Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.

With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.