The rising challenges in Pharmacovigilance in the wake of Covid-19

• Aug 12

The importance of monitoring the safety of drugs, vaccines and medical devices has been stressed upon in the backdrop of a world health crisis. While the healthcare industries in every country are bent down upon coming up with effective vaccines, the stakeholders of Pharmacovigilance / Drug safety have been proactively working towards monitoring their safety. However, the Pharmacovigilance industry has been facing persistent challenges in its functioning, owing to operational disruptions due to the pandemic. The volatility of the situation demands clinical remedies and therefore, pharmaceutical giants have been under duress, making every effort to bring about time-sensitive and effective solutions in the form of Covid-19 drugs and vaccines.

In the process of finding a solution within time constraints, the Pharmacovigilance industry shoulders the task of monitoring unknown short and long-term adverse drug reactions (ADRs), which are crucial in analysing the effects of drug and vaccine use. Therefore, adopting a potent safety strategy and sustainable Pharmacovigilance mechanism is a pressing priority to encounter the challenges.

Challenges in Pharmacovigilance during Covid-19

To contain the spread of the virus, countries all around the world imposed complete or partial lockdowns, which lead to the closure of facilities for Pharmacovigilance professionals. This resulted in a change of routine audits and safety inspection activities, which also affected the amount of work pertaining to non-Covid products. The inflow of information and data on non-Covid products saw a steady decline as a result of lesser visits to the hospitals and a bare minimum focus on other pathologies.

Another massive challenge in ensuring regularity and efficiency in operations is the decreased pool of professionals owing to social distancing and quarantine norms. The lack of access to ADR monitoring centres and a reduced pool of human resources in Pharmacovigilance has made reporting and collection of data at the same speed a tedious task.

As the challenges in the face of the raging pandemic surface, the opportunities must be seized and solutions capitalized upon to minimize adversities. Notwithstanding the plight of the pandemic, the Pharmacovigilance system has been aligned with healthcare workers in a way to make it more patient-centric.

Opportunities and Solutions in Pharmacovigilance during the pandemic

Moving ahead in the Pharmacovigilance sector, the stakeholders of the industry are working increasingly towards harmonization across countries. Now that the healthcare providers are leaving no stones unturned to ensure the reduction of the Covid-19 strain, the reporting and collection of data have been devised remotely for amplified efficiency and easy accessibility of the patients. Pharma workers are leveraging the internet as a service for the remote collection of adverse effects. Active participation from the patients in safety reporting on social media and company websites has marked the seizure of an opportunity of extreme potential in the future.

With organizational communication being limited to virtual conferences, creating a reliable channel of sourcing data, analytical information and reliable safety data exchange agreements must be the task at hand. The channel must also function within a compliant timescale and abide by the regulations governing them. To ensure prompt response to regulator safety inquiries, identification of necessary resources for the response and development of the right strategies must be undertaken. Moreover, the development of cost-effective, paperless solutions for managing legacy safety data and Individual Case Safety Reports (ICSRs) are indispensable for seamless communication within the industry.

Post the identification of potential risks, the development of appropriate risk management plans are the next big task. A robust mechanism for the development of Pharmacovigilance literature screening and innovative writing solutions for various aggregate reports such as DSUR or complex PSURs and/ or PADER (as a part of patient drug safety services) must be constructed to ensure prioritized public safety. Also, Pharmacovigilance workers must strive towards the development of world-class Pharmacovigilance expert services for carrying out benefit-risk analysis and providing advice on strategy and new safety concerns for the benefits of mankind. Lastly, Pharmacovigilance consulting services for the system development, inspections and interpretations of audits, SOPs etc. must be provided to prioritize customer safety.

To counter the above-mentioned challenges (primarily home to North America and India), the improvisation of the best cost-effective end-to-end patient drug safety services have been undertaken by various Pharmacovigilance service providers. The mitigation of these challenges through the tenable development of a Pharmacovigilance infrastructure shall also fuel the industry in upcoming operational activities.