Pharmacovigilance in the pandemic era

The virus versus the mankind: A scenario that we have never assumed would ever come in our lives. The whole world is strangling with the unforeseen pause brought by a species which we cannot even visualize with our naked eyes. The governments of all the nation are struggling day in day out to protect the people from the infections while these challenges are also impacting the global economy. The present scenario of COVID-19 poses an unprecedented challenge to the healthcare sector around the world. While there is a ripple of clinical trials worldwide to find the most suitable vaccine for combatting the virus, we cannot ignore the significant role played by the pharmacovigilance sector in this context.

Before dealing in depth with the significance of pharmacovigilance, I would like to give a brief of the concept.

According to WHO [1], pharmacovigilance is another term used for “drug safety”, and is defined as the science of collecting, detecting, assessing, monitoring and prevention of adverse drug reactions due to any pharmaceutical products. Information of this received from the patients or the healthcare providers to the pharmacovigilance centers who assess the necessary data and submit the report to the local drug regulatory bodies. For any company to market its drug, the adverse drug reactions report need to be submitted to the drug regulatory authority, who will finally judge whether that particular drug has to be restored or withheld from the market. Basically, the pharmacovigilance is concerned with minimizing the hazardous effect of any pharmaceutical product towards mankind. The sole motto of the pharmacovigilance is “patient safety”. The government of every nation has authorized pharmacovigilance centers apart from the contract research organizations which also conduct pharmacovigilance on behalf of the drug companies. However, there still lies a huge gap in the knowledge of pharmacovigilance and its importance amongst the patients who fail to report the adverse events that they experience, to the proper pharmacovigilance centers. Thus, governments are taking an extra urge to educate the community more about reporting the adverse drug reactions due to any pharmaceutical products to the pharmacovigilance centers.

Now the question arises, as what is the role of the pharmacovigilance in this pandemic atmosphere?

Ensuring patient safety by monitoring the effects of medicines has always been the top priority for the pharmacovigilance domain. Apart from the innumerable ongoing trials to develop the anti-COVID-19 vaccines, many drugs have been identified of having potential to fight back the coronavirus infections. Novel drugs such as remdesivir, and many conventional drugs namely hydroxychloroquine and lopinavir/ ritonavir are now being used as a prospective drug against COVID-19 and its symptoms. According to the individual case safety reports presented by the Uppsala Monitoring Centre, there are several adverse drug reactions reported on those drugs. Moreover, as the ongoing clinical trials have already stepped into the Phase 2 and phase 3 and therefore the subjects of the clinical trials have already received the injections [2]. Hence, it is the utmost necessity to monitor and report about any adverse reactions so that the best vaccine can emerge into the market while restoring patient safety.Amidst this complex situation, it is the golden opportunity for the healthcare system to come proximity to the pharmacovigilance process. Timely monitoring and collection of data from the ongoing clinical trials as well as from any patients receiving the prospective medicines, can provide vital information to the healthcare providers on a daily basis. Sharing the information and knowledge about the adverse drug reactions pertaining to those pharmaceutical product to the regulatory bodies worldwide, as well as communicating through social media, can reduce the task of drug safety officers of smaller pharmacovigilance centers on around the world. In this way the pharmacovigilance experts can team up with other drug companies or scientific organizations to demonstrate the significance of spontaneous reports as a form of real world data. In this way, a chain of signal detection around the world would be generated which would highlight the most efficient drug against the corona virus, to be used by the community without any hazardous effect. Thus, it is the high-time, that we support the process of timely reporting of any adverse event to the healthcare officials and be a part of the worldwide pharmacovigilance system.

The pandemic has generated an unparalleled global crisis. However, in this urgent crisis period, the governments and healthcare sectors have taken the utmost responsibility to tackle these challenge period without compromising the importance of the patient safety. The drug companies and scientific organizations are carrying out the clinical trials in a roller-costar speed, but they cannot afford to miss the sight of patient safety. Therefore, at this crucial time, the pharmacovigilance experts showcase their vital task of monitoring and ensuring patient safety worldwide. The near future awaits a vast scale vaccination program. The monitoring and reporting every minute details of the adverse reactions is very much needed. As health care professional we have to be the torch bearer to educate our society about the prominence of pharmacovigilance in this era.

Referances:

1. The Importance of Pharmacovigilance, WHO 2002
2. Chandler, R.E., McCarthy, D., Delumeau, J.C., Woolrych, M.H., The Role of Pharmacovigilance and ISoP During the Global COVID‑19 Pandemic,Drug Safety (2020) 43:511–512, https://doi.org/10.1007/s40264-020-00941-4.