The COVID-19 pandemic has brought about unprecedented changes in the healthcare industry, including the Pharmacovigilance (PV) process. The pandemic re-emphasized the role of PV in the pharmaceutical industry. As personalized medicine gained popularity, the tactics of pharmaceutical manufacturers and the PV process flow for ensuring the end-user’s safety had to alter. The drug/Medical Devices & Vaccines (MDV) manufacturers faced more challenges as the market transitioned towards personalized medicine, which led to an alignment with new trends and technologies. In this blog, we will explore the current trends in PV in the pharmaceutical industry post-COVID-19.
Accelerated Regulatory approvals of new drugs and MDV were introduced to combat COVID-19 and have led to the need for post-marketing PV safety monitoring in clinical trials. To ensure the safety and effectiveness of these products, Regulatory authorities have implemented more adaptable regulations for safety monitoring and reporting Adverse Events (AEs) after the drugs/MDV are released onto the market.
For instance, some Regulatory agencies have provided guidance regarding the role of PV in clinical trials, especially on clinical trial reporting and post-marketing AEs. Listed below are guidelines from specific Health Authorities:
United States Food and Drug Administration (US FDA)
The FDA has developed a database that contains AE reports, medication errors, and product quality complaints called the FDA Adverse Event Reporting System (FAERS). Voluntary reporting by healthcare professionals, consumers, and manufacturers can be done on the FAERS database using the MedWatch website which is the FDA’s “Safety Information and Adverse Event Reporting Program” for reporting adverse and sentinel events.
European Medicines Agency (EMA)
The EMA changed its recommendation on June 29, 2020, following a four(04)-week public consultation. In accordance with this guideline, the EMA is more flexible and pragmatic in its evaluation of impacted clinical trial data submitted as part of marketing authorization applications.
Medicines and Healthcare Products Regulatory Agency (MHRA)
The MHRA guidelines intend to perform expanded passive surveillance via the Yellow Card vaccination AEs reporting method, by searching for signs of reported incidents that exceeded what the Agency's scientists anticipated seeing. Through reporting on the Yellow Card app, the government Agency expected to detect early warning signs for common problems as well as the rarest of side effects post COVID-19. Additionally, the MHRA uses its Clinical Practice Research Datalink (CPRD) on a weekly basis for rapid cycle analysis in the search for pre-defined events.
These guidelines and data have led to increased transparency and coordination in the monitoring and surveillance of drug/MDV safety and PV in clinical trials. But the need for effective communication and cooperation has become more apparent as this function of PV enables the timely identification and reporting of adverse drug reactions.
Information-sharing allows for a more comprehensive understanding of drug/MDV safety profiles, benefiting patients and healthcare professionals.
To address the rapid increase in reported AEs, the PV industry has embraced technological advancements in processing case reports. PV services provide companies with high-end technological backups, enhanced cloud-data base accessibility, and an effective business community plan to meet PV deliverables in the shortest possible turnaround time while being compliant. Following are a few technological innovations that emerged significantly post-COVID-19:
- Robotic Process Automation (RPA).
- Natural Language Processing (NLP).
- Pharmacovigilance Artificial Intelligence (AI).
- Other high-end, secured cloud networks and automation tools.
Real-World Data(RWD) Usage
The role of PV in the drug/MDV development process has also increased with the advent of RWD. RWD outcomes have been essential in creating COVID-19 vaccines, which were approved for emergency use based on minimal clinical evidence. As more patients got COVID-19 immunizations, there was growing evidence that these vaccines were safe and efficacious. It was an excellent illustration of the RWD use case in mainstream life. RWD was instrumental in:
- Providing crucial insights into the performance of drugs and MDV.
- Highlighting the possible AEs.
- Identifying potential safety signals.
- Facilitating timely risk mitigation measures.
Therefore, by contributing to better patient outcomes, RWD has emerged as a critical tool for monitoring the real-time safety and efficacy of pharmaceutical products.
Scaling and Managing Resources
There has been a significant rise in the PV industry for the experts to skillfully increase work opportunities and outsource PV services to improvise the Key Performance Indicators (KPIs). In response to the surge in AE volumes during the pandemic, the PV industry had implemented strategies to manage resources effectively, including the following:
- Scaling in-house resources and enhancing workforce mapping capabilities.
- Outsourcing services to increase work opportunities for skilled resources and delegate manual tasks to remote workers.
- Recalibrating KPIs and aligning dedicated teams for greater flexibility.
Clinicians and researchers have embraced these strategies to manage the increased workload post-pandemic. Adopting a dedicated team approach and remote work culture has become prevalent in the PV industry. It was one of the trends that had been particularly effective during the pandemic, allowing PV experts to work securely from remote stations.
Post-COVID-19, PV has transformed significantly, adapting to new Regulatory norms, adopting advanced technologies, and leveraging RWD. The pandemic has also propelled efficient resource management, including remote work and outsourcing. This evolution reaffirms PV's pivotal role in ensuring patient safety and drug efficacy, heralding a new era in healthcare.
Partnering with a proven, end-to-end Regulatory service provider for PV like Freyr can help pharmaceutical companies ensure compliance and patient safety and drug efficacy. Contact us for more information.