Supporting Pharma in AE Reporting Is Tricky

  Feb 25, 2014 1:44:00 PM

Therigy is featured in a Specialty Pharmacy Continuum article discussing the different responsibilities related to supporting pharmacovigilance adverse event (AE) reporting requirements. 

 

Some highlights of the article include: 

"Manufacturers and pharmacies have different requirements to report AEs. Manufacturers are held to a higher standard by FDA. As a result, tension can occur when balancing the requirements for the specialty pharmacy versus those for the manufacturer, said Jon Hamrick, MBA, Therigy's executive VP of Biotech and Specialty Services." 

"During a panel presentation at the 2013 Therigy Specialty Pharmacy Leadership Congress, Mr. Hamrick called on attendees to "work to figure out how to do this, how to solve these tension." 

"When you are on the phone with a patient administering a clinical program, we often ask a patient how to feel. Patients might volunteer some information about an event that the pharmacy, on its own, would not have to report. But when working on behalf of a manufacturer, the same event, must now be reported as an adverse event. You have to be careful [if you] don't want to screen for every adverse event under the sun. That can have a big impact on clinical operations, Dr Duong said." 

"Mr. Hamrick said, 'It's a real catch-22 for pharmacies and manufacturers because essentially any incident is reportable in terms of a manufacturer requirement, but at the same time, these specialty patients are among the sickest. So, almost any interaction a pharmacy has with that patient could yield a reportable event." 

"Humans have some limitations in remembering which adverse events need to be reported, especially when there are multiple sets of requirements, among different manufacturers and regulatory bodies." 

 

To read the entire article, please click here