Blockchain Pharmacovigilance (PV) deals with detection, medical assessments, evaluations, monitoring and, prevention of (ADRs)1. However, the apparent increase in the data volumes of ADRs are putting a lot of pressure on pharmaceutical companies to ensure patient safety, and assure compliance. According to FDA (US Food and Drug Administration), as many as 334,395 new ADR reports were received in quarter 1, 2019 alone2.
This POV will explore how Blockchain can help addressing all the challenges that the pharmaceutical companies face during PV process.
PV plays a critical role in the following areas:
- Patient/sonsumer safety: Creates appropriate reporting structure to assess and monitor drug both in clinical trials and post that
- Regulatory obligations & compliance: Creates appropriate protocols for drug recalls, issuing patient/consumer warnings and, assure compliance
- Enhanced process: Creates and provides a better assessment and evaluation for the drug companies to ensure long-term viability for the business and improved trust from the patients/consumers
What are the current challenges in Pharmacovigilance?
With the rapid increase of information across the globe, Pharmacovigilance (PV) practices/ departments need to face enormous and endless challenges in keeping up with the public expectation of drug safety, managing various channels/systems to report ADRs and clinical trials, dealing with a complex and large landscape of legacy systems, data security & privacy, and evolving regulations.
It is of utmost importance to have a comprehensive and thorough understanding of current challenges in PV practice to be able to address these challenges and craft an approach using enhanced technological solutions.
PV lifecycle diagram (Figure 1) depicts the overall PV process and the current challenges faced by PV departments.