Non-Standardized Approach to Adverse Event Reporting Creates Challenges for Specialty Pharmacies

UBC's expertise in pharmacovigilance services makes patient safety the highest priority

Non-Standardized Approach to Adverse Event Reporting Creates Challenges for Specialty Pharmacies

One thing is clear – patient safety is top priority for specialty pharmacies and manufacturers.  What’s not as clear is the appropriate process for handling adverse event reports through the specialty pharmacy.  Reasons for confusion – and increased challenges – include:

  • Specialty pharmacies traditionally have followed local state pharmacy laws, yet manufacturers have different, more stringent, requirements.
  • Staff supporting Reimbursement programs or Patient Assistance Programs may require additional training as agents of the manufacturer. 
  • Increased industry globalization requires meeting both US and international regulatory requirements. 

Meeting these challenges is essential to a strong pharmacovigilance program. 

Kevin Cast weighs in on this topic: Supporting Pharma in AE Reporting Is Tricky in the latest issue of Specialty Pharmacy Continuum.