PV 2030 Outlook: Embracing Data – Driving Accountability and Participation

Pharmacovigilance, Life Sciences, Regulatory Compliance, "Drug Safety", Implementation, Data Migration, PV, Signaling, Adverse Event

At the beginning of the decade the emerging postulates of Healthcare, the 4 Ps- predictive, preventive, personalized, and participatory were considered largely speculative. Fast forward to 2020 and there is an increased acceptance of this vision largely due to the rapid progress made in the sphere of technology coupled with proliferation of data.

Pharmacovigilance isn’t untouched by this and thus finds itself at an inflexion point of sorts.

While the traditional ICSR will continue to stay relevant given it still accounts for 55% of all new drug safety issues detected and a significant proportion of drug recalls, there is a need to conduct this process much more smartly with the injection of automated and learning techniques that allow for Pharmaceutical companies to deal with a lot more data and focus their energies on inferring information as against processing data.

Opportunities have increased to leverage the exponential growth in real‐world data, including data from EHRs, disease specific registries, insurance claims data, mobile applications, wearables and social media. The upcoming adoption of common data standards (R3, IDMP) to allow for better interoperability will ease this process and thus embracing newer forms of data will be an asset for Pharmaceutical companies looking to advance patient outcomes.

With better availability of data and tools and dissociation of safety and efficacy in the evolving regulatory framework, the onus will be on companies to be accountable for the performance of their drugs in the marketplace. Data can be analyzed and fed into decision making by Regulators and Pharmaceutical companies for product labeling and as health information to support individual decisions by healthcare professionals and patients.

A digitally networked arena witnessing increasing determination of healthcare consumers to better manage their own health using the internet to gather information and their ability to self‐organize using social networking tools is driving participation. This change in user behavior creates long term opportunities for Regulators to engage patients and healthcare professionals much more intensively. Opportunities include electronic product information updated in close to real‐time supporting decision‐support systems for the prescription, dispensing, or use of medicines.

Thus, it is in the interest of Pharmaceutical companies to leverage best in class technology solutions allowing them to embrace rapidly expanding data volume & diversity, driving engagement, participation and accountability.

Watch this space for these developments and Ultragenic’s active involvement…