DDReg Pharma

DDReg Pharma
Drug Safety

Social & Digital Media Sources in Drug Safety

A crucial part of pharmacovigilance (PV) and post-market drug safety surveillance are unsolicited adverse event (AE) reports from various stakeholders including patients, pharmaceutical organizations, and healthcare professionals. These are spontaneous reports and serve as important sources of safety information for a product. Regulatory agencies rely on spontaneous reports for post-market safety surveillance from which they determine the necessary regulatory and safety actions that need to be conducted in order to mitigate the risk of patient harm.
While spontaneous reporting systems have formed a strong source of post-market safety surveillance data, they are also associated with limitations such as delayed reporting, under and/or over-reporting of adverse drug reactions (ADRs) and AEs, and more. Interestingly, regulators are increasingly incorporating data from various social media as more patients turn to online and digital platforms to learn more or communicate more information about an AE they are experiencing [1]. While social and digital media platforms can provide early warning signals regarding potentially serious AEs, the validity & authenticity of the AE, the volume of AE reports, and follow-ups regarding the same are a challenge in the PV landscape.

Challenges regarding social media platforms

One of the common challenges that PV professionals face is the validity and authenticity of the AE posted on a particular social media platform. Who reported the AE? Did they report it in real time? How accurate is their analysis? Furthermore, the possibility of the AE post on social media being seen by a large volume of users is far greater; such misinformation could cause fear among other patients using the same drug and lead to them prematurely discontinue the treatment. Additionally, as AE reporting on social media is far more straightforward and convenient than reporting spontaneous AEs through traditional means, the volume of AE reports is relatively larger which burdens pharmaceutical organizations, MAHs, and PV professionals that must review the data for potentially serious and rare AEs. Finally, traceability to the reporter is limited through social media platforms compared to traditional reporting systems that mandate information on the AE, the drug, the reporter, and their contact details [2]. Hence, AE reports from social media platforms could create obstacles particularly given the rapidly changing regulatory environment. While social and digital media AE reports add to the volume of safety information available for post-market surveillance, the debate on their authenticity still remains and is foreseen as an ongoing challenge in drug safety.

Support from Regulatory Authorities

The evolution of social media platforms, associated technology, and the number of people that use it for various purposes has been under the spotlight. In this ‘tech-savvy’ era, being smart with such platforms puts people at an advantage by having resources at their fingertips. This holds true for regulatory and drug safety aspects that have led to stringent authorities, such as the US FDA, in introducing guidance documents to address the following:
  • How manufacturers, distributors etc can fulfil regulatory requirements for post-marketing submissions in the promotional content posted on social media [3];
  • How pharmaceutical organizations can tackle problems related to space & character limitations [4];
  • How companies can proactively and compliantly correct misinformation communicated by third-party social media vendors regarding their products [5].
Despite the implementation of draft regulatory guidance documents, several gaps regarding the validity of AEs remain leading to burden on PV professionals for efficiently capturing ICSRs and AEs.

Pharmacovigilance support with DDReg

The team at DDReg is experienced in handling a range of ICSR and AE sources including but not limited to solicited, unsolicited, literature, regulatory, clinical trials & interventional studies, non-interventional studies, patient registries, market reports, spontaneous reports, social media and more. The team of PV professionals, medical experts, and physicians, conduct meticulous review and analysis of ICSR and AE reports from disparate sources to detect potential signals as early as possible.

References and further reading:

[1] Fox S, Duggan M. Health online 2013. Health. 2013;2013:1–55

[2] Naik, Paulami, et al. “Regulatory definitions and good pharmacovigilance practices in social media: challenges and recommendations.” Therapeutic Innovation & Regulatory Science 49.6 (2015): 840-851.

[3] United States Food and Drug Administration. Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. January 2014. Accessed January 2023.

[4] United States Food and Drug Administration- Federal Register. Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. September 2014. Accessed January 2023.

[5] United States Food and Drug Administration. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about Prescription Drugs and Medical Devices. June 2014. Accessed January 2023.