WHO defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.”
Pharmacovigilance focuses on drug actions, adverse reactions, and overall drug quality and monitors its effect on the health care system, thus protecting the patient population. Drug manufacturers regularly conduct drug safety and pharmacovigilance audits to stay compliant with FDA guidelines and other regulating laws and guidelines as applicable in different countries all over the world. Over the past few decades, pharmacovigilance systems have made significant progress. However, there are some common challenges that every pharmacovigilance system faces, which are often interrelated. Some of these are:
The current system being outdated:
Look back a decade ago, and you will see the pharmacovigilance environment was still in its nascent years. Although we have made significant progress in the last few years, the scenario has not changed completely. From limited integration of data to inconsistency in data standards, the primary challenges remain the same. Moreover, today, the pharmacovigilance industry still struggles with expensive and outdated systems. On the other hand, complexity has doubled due to the increased influence of emerging markets. Moreover, the data volumes have increased manifolds. Researchers are expected to do a lot more using the same old legacy systems.
Change in regulations:
Over the years, there had been a lot of regulatory changes globally, especially in the US and EU, and at times works elaborately too. Moreover, each country has its regulations and pharmacovigilance system. In the emerging pharmacovigilance system, the hospital and regulatory agencies’ roles vary greatly with countries where the pharmacovigilance system is more developed. In such countries, the pharma industries have a more profound role in pharmacovigilance. In short, differences and changes in regulations mean workflows and processes need to be changed. A collaborative ecosystem may help to better manage the changing regulations.
Surge in pharmacovigilance in the post-pandemic period:
To combat the COVID-19 pandemic, many countries are working actively towards finding a suitable vaccine. For the months and years to come, there will be several trials going on which need to be monitored. Thus, it is safe to infer that there will be a surge in need of safety and pharmacovigilance solutions in the coming years.
The need of the hour: A robust solution
The need for a robust, simple, configurable, and scalable safety pharmacovigilance solution is apparent. The COVID-19 pandemic has made us realize that we need to work holistically to combat the deadly virus. And hence, the need for a single platform is the need of the hour to collaborate in real-time and work towards a common solution in a cost-effective and timely manner.
For many pharmacovigilance teams, one most significant challenge is a delay in the outcome, most of which can be avoided by technology intervention. Most of the delays occur due to manual and time-consuming reporting processes, which intensify when you need to handle the post-marketing adverse events spontaneously. At the same time, you need to adhere to all the regulations and compliance set by the FDA and other governing bodies.
With the rapid rise of pharmacovigilance case volumes due to the COVID-19, it is high time to invest in a single platform that takes care of all the above-discussed challenges, including risk mitigation and data analysis. A single robust platform for pharmacovigilance teams fosters a collaborative ecosystem, increases transparency, improves compliance and greater operational efficiency.
Finally, with leveraging technologies like artificial intelligence, medical coding, automation, we are now well set to introduce a robust single pharmacovigilance platform that is easy to use, minimize human involvement and thus eliminate the scope of human errors. Such platforms would enable operational efficiencies, clinical studies, study of safety, and risk management programs to protect the patient population.