With the advancement in the medical field and the invention of new vaccines, medicines, and drugs for treating small to deadly diseases there is also a need for pharmacovigilance for safety purposes. There is a critical need for awareness of the safety check on the medicine by testing and understanding the effects for the prevention of later problems. The World Health Organization (WHO) has also taken the initiative to address the need for pharmacovigilance. In this article, we will discuss pharmacovigilance, its objectives, goals, and the need and the regulatory framework in Asia.

Pharmacovigilance: Objectives and Need

Pharmaceuticals and drugs have a major role in day-to-day life and in leading a healthy life, but medicines and vaccines cause some of the side effects. Pharmacovigilance is the testing process that is used in the detection, assessment, learning, and prevention of the unpredicted later effects of drugs or medicinal problems. Though all medicines and drugs undergo several stages of testing with industrial trials of a small number of people before they are circulated in the market, some of the unknown effects will be caused when used by multiple diseased persons and long usage.

Objectives:

The primary objective of pharmacovigilance is to assure the safety of the patients by the consumption of medicines. This includes analyses of the risks associated with the medication. Detection of the adverse drug reactions (ADRs) and other safety checks at the early possible stage. Regulatory compliance is to be ensured for the safety monitoring. To promote the understanding and assessment conduction on the effects of drugs along with the creation of awareness and educating the public on the same. The main purpose is to maintain public health and to undertake preventive measures to ensure the safe usage of drugs and medicines.

Need for pharmacovigilance

There is an inevitable need for pharmacovigilance as the monitoring process of the side effects of the medicine is a must in maintaining public health and also to avoid the cause of another disease by the effect of a medicine. Regularly analyzing and maintaining the reports of the particular medicine and its effects will lead to modification and betterment to make it less harmful to use. 

Phases in Pharmacovigilance 

The are three main phases involved in pharmacovigilance that make the process more effective in measuring the safety checks they are 

• Pre-Clinical Pharmacovigilance: This phase includes the testing of the before it is been sent for usage by regulatory authorities. The risks are identified by testing the medicine on animals and clinical trials 

• Clinical Pharmacovigilance: It is the testing of drug effectiveness through clinical trials in a controlled and specific environment, wherein professionals and experts in the field and industry are closely involved. This phase ends with the requirement and need for the drugs being tested to pass approval from the concerned authorities before use.

• Post-marketing Pharmacovigilance: In this phase, the safety monitoring is for the long-term and done once it is approved for use and is available in the market. The reporting of the effects is done voluntarily by the patients, pharmacists, and medical professionals through their regular usage and the effects faced.

Conference and more 

There are initiatives taken to create awareness about the need and importance of pharmacovigilance like organizing of the world conference which is the platform to discuss and take the necessary actions. The conference provides a unique platform for several medical researchers and professionals to discuss their thoughts on the challenges, problems, and solutions in pharmacovigilance. The conference includes experts from different fields like academics, industry specialists, regulatory boards, and others to explore the various key factors of drug safety.

Pharmacovigilance regulations at the global level are being monitored by the agencies named European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA), and the Food and Drugs Administration (FDA). The three international pharmacovigilance systems are the WHO Uppsala Monitoring Center system, the European Union (EU) pharmacovigilance system, and the International Conference on Harmonization (ICH) system which focuses on drug safety and public health.

Conclusion 

In short, the monitoring of drug safety to avoid adverse drug reactions to the health upon the consumption of the medicine is very crucial. Hence the need for the effective and advanced testing of drugs by clinical trials can be beneficial in protecting public health. Pharmacovigilance and other processes in the pharmaceutical industry need to be followed and regulated to provide effective medicine for making a healthy society.