Clinical and Experimental Psychology

A Study to Evaluate Pharmacovigilance in the Clinical Trials Process

Aditya Mishra^{* *}Correspondence: Aditya Mishra, Bhim Rao Ambedkar University, UP, India, Email:

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Introduction

Pharmacovigilance is the science or branch that deals with the unwanted, undesirable i.e. ADR (Adverse Drug Reaction), its detection and prevention to the human subject or we can be said that the factors which are affecting the drug averse effect this Pv department detects this defect and check how to prevent it and make a report. Pv main motive is to find new information about the noxious effect which is related to the drug product. From this, it helps to better patients’ health care and safety, upgrade humans’ health and safety and increase understanding, and education as well as do clinical training in pharmacovigilance. So these are some of the objectives of Pv. This pharmacovigilance works started with adverse drug reaction suspicion after this, Pv works on making reports so that on the bases of the reports we can analyze the adverse drug reaction and after this reporting as well as analysis we start finding the ADR. There are various patterns in pharmacovigilance that help this department to spread worldwide and ensure the safety of the drug firstly WHO (World Health Organization) helps to promote pharmacovigilance from country to country [1,2]

UMC (Uppsala Monitoring Center) is an independent drug safety center and research center which works worldwide to make sure the security and effectiveness of the drug and drug products. The national pharmacovigilance center is the center that takes charge to check the adverse effect of the drug. Hospital and academia is the area where these clinical trials are conducted and from where Pv takes data to check the results. So these are the various partners which are associated with pharmacovigilance during the clinical trials (Table 1).

Table 1. Types of ADR and its severity.

Methodology

When the API reaction occurs they convince the government to make a new law because when testing occurs on animals as well as on human beings then they show adverse effects. Generally, these reaction occurs in small human population this is the reason that the ADR is not fully recognized when the drug is marketed and tested on a larger population of 3000 human to 5000 human subject the proper data is recognized and the licensing authority (i.e. CDSCO & DCGI) compel the marketing agency to send the feedback or ADR information of the new drug In the late 20th century clinical trials were done only by the USA and the data which gets is of US human subjects or US population this data India used to apply to their human population but this is ethically and genetically wrong data so to overcome this type of problem. India started doing clinical trials and phase 2 and phase 3 clinical trial mandatory for each and every drug. This is the phase when the pharmacovigilance program comes to India. Nowadays this pharmacovigilance plays important role in a clinical trial because this clinical testing occurs on the same population which sponsors or initiates the clinical trials. Once the data is formed, it is easy to analyze any adverse drug reaction in the population and find the caution and cure for the ADR of the drug. When any serious or lifethreatening ADR occurs then withdrawal of the drug is an option. For this kind of factor, it becomes important for health workers/professionals to report adverse drug reactions. These healthcare professional reports the adverse drug reaction to the government so that government take action like withdrawing are some change in the medication to make sure that this ADR does not do harm to anyone’s health [3-5]. In India, this pharmacovigilance program is conducted by two ministries i.e. IPC & CDSCO. Generally, this pharmacovigilance program is controlled by IPC and headed by DCGI. In simple, we can say that the manufacturers, marketing authorities’ companies, importers of the drug, and health workers/ professionals are the most common pillars of this pharmacovigilance program (Table 2).

Table 2. Drugs that are withdrawn from the market

Conclusion

Pharmacovigilance is involved into a most important role i.e. drug control. It is the ideal system which likely to take the poor nations for spontaneous monitoring of the ADR for their foreseeable future. It is help to know the initial risk and the harmful risk of each and every drug molecule. The results show that this is expectable that 50% to 75% of the health risks are curable as well as think lesser about the security of the drug and higher about the human subject protection their uses & concern that how it reacts to our body. It thinks less about the regulations including withdrawal give rise to atomization of the data input which is more useful for the information output. Its main concern on the drug impact on our body

References

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