Social media has been a rising point of concern for pharma companies with regards to the monitoring of patient communications about drug safety, but a new service could help track online activities.
Patient reports have been notoriously hard to rack on tools such as Facebook and Twitter, leading to such regulatory concerns such as Roche last year, with the Swiss pharma company found to have “serious shortcomings” with regards to pharmacovigilance practices following an investigation by the European Medicines Agency (EMA).
Life sciences consulting company YourEncore says its new service to track social media communications – which evolved from previous work with a pharma company – could help avert future regulatory breaches such as those committed by Roche.
“Drug makers may have hundreds of patient outreach programmes worldwide gathering patient safety information every day without the required regulatory controls,” said Pam Holland, YourEncore’s managing director, life sciences.
“We help ensure that all past and future safety information is handled according to the law.”
The service was developed after YourEncore experts visit an unnamed pharma firm’s operations across more than 20 countries, reviewing its patient outreach programmes in order to identify shortcomings and enhance reporting standards.
Regulatory agencies are also doing more to help pharma companies comply with the pharmacovigilance rules amid the rise of online technologies.
This includes the publication at the start of the year of draft FDA guidance on ‘interactive promotional media’, encompassing Twitter, Facebook and blogs.