As the medical and scientific community work tirelessly to find suitable treatments for COVID-19, pharmacovigilance research is essential to understanding the safety and efficacy of treatment alternatives.
To collect sufficient information about the efficacy and adverse drug reactions of treatments used against COVID-19, it’s crucial that all adverse events are recorded and reported as quickly as possible.
Several therapies with the potential to treat coronavirus infections have been identified and are currently being deployed in many countries. New drugs, such as remdesivir, are being tried and several old drugs, such as hydroxychloroquine and lopinavir/ritonavir, are being repurposed. Already, reports of suspected adverse drug reactions for some of these therapies have reached VigiBase, the global database of individual case safety reports, managed by Uppsala Monitoring Centre. Moreover, multiple vaccines of different types are under development, and the first participants in clinical trials have received injections. Given the vast scale of vaccination programmes likely to result – should any successful vaccine candidates emerge – monitoring and detailed reporting of all adverse events will be vital.
Timely review of the incoming data and real-time signal detection can provide important safety information that healthcare providers desperately need. Therefore, ensuring and supporting the collection of high-quality data from adverse event reports will be essential responsibilities.
Risk communication is difficult under normal circumstances, will be an even greater challenge given the amount of uncertainty that surrounds all aspects of the pandemic. It is important to share information on suspected side effects from any of the medicines used to treat COVID-19, as well as how medicines taken by patients to manage long-term, pre-existing conditions are affected by the infection and treatments used. By sharing knowledge and insight into regulatory decisions, as well as communication materials and social media campaigns, can help to lighten the burden on the staff in many of the national pharmacovigilance centres throughout the world.
Pharmacovigilance experts can collaborate with other scientific organisations to demonstrate the value of spontaneous reports as a form of real-world data. And can combine queries of spontaneous databases with real-time observational studies from big data networks of insurance claims and electronic healthcare records to allow for more efficient evidence generation and explore any medicines safety issues that arise.
At this time, perhaps more than ever before, pharmacovigilance experts have a vital role demonstrating how our expertise, knowledge, and methodologies can help protect the safety of patients worldwide.
Refer below links for Guidance on adverse event reporting and coding guidance provided by UMC:
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