Technology - A Boon to Drug Safety Industry trends and the importance of Drug safety
By Mayank Raizada, Managing Consultant, Navitas Life Sciences

Published in Pharma Times - 08 - August 2015

The United Nations report, ‘The World Population Situation in 2014’ suggests that the world’s population has undergone a transition, from high birth and death rates to low birth and death rates. Phenomena of an aging population are more pronounced in developed countries, but life expectancy has universally increased and the change is significant. However, with extended life expectancy comes chronic, infrequent, and expensive (to treat) conditions.

An aging population has led to a shift in the economics of drug manufacturing. Product portfolios have been re-prioritized from traditional disease(s) to ailments impacting specific populations, or for handling chronic conditions using advanced and novel treatments.This change has brought about a new focus on the Benefit-Risk assessment of drugs, both from a patient safety and an economic (product positioning) perspective. Drug safety is a key stakeholder in managing the Benefit-Risk analysis of a product. Moreover, the potentially devastating impact of an adverse effect to the patient going undetected has enhanced the profile of Drug Safety from a supporting function to a key stakeholder sustaining pharmaceutical products in the market.


Gone are the days when safety reports, including privacy and blinded information, sometimes redacted were put in separate bins while exchanging paper based safety case files. Cases are now processed paperless within the safety systems. A lot has happened in terms of technology in drug safety in the last five years. We have seen secure data storage and efficient information exchange between partners, regulators and vendors that has largely been achieved due to existing regulations that have led to standardisation of the safety data. Furthermore, business intelligence tools designed to view and visualize safety data use the latest technologies to process the data, providing creative ways to present the information and assist in spotting trends and signals which, ultimately, helps in managing patient safety.

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