Review on Concept of Pharmacovigilance

Journal of Pharmacovigilance and Drug Research

The objective of this narrative review is to converse about drug safety, global pharmacological authorities and their responsibility, the process of adverse event reporting, and the main functions of pharmacovigilance. Pharmacovigilance is a science that ensures patient safety against both newly launched and well-established medicinal products in the market. Pharmacovigilance is considered a specific tool used for observing and estimating Adverse Drug Reactions (ADRs) and is essential for successful drug management programs, clinical trials, and public health programs. In the few past years, the number of reported ADRs got increased as a result of which the volume of data got increased. To handle such huge data and the need to understand the pharmacovigilance, it requires highly skilled and proficient people for immediate detection of drug's side effects and protects the product from improper removal. The existing global network of pharmacovigilance centers will be strengthened ...

Joint Bone Spine, 2006

a Medical and clinical pharmacology laboratory, pharmacoepidemiology unit, EA 3696, IFR Inserm 126, Paul-Sabatier university, school of medicine, Toulouse, France b Clinical pharmacology department, Midi-Pyrénées center for pharmacovigilance, pharmacoepidemiology, and drug information, Toulouse teaching hospital,

International Journal of Advanced Research, 2020

Journal of Drug Delivery and Therapeutics

Pharmacovigilance outlined by the globe Health Organization (WHO) because the science and series of activities about the detection, evaluation, understanding rejection of adverse impact or Associate in Nursing different drug connected problem’ and a clinical test could be an analysis study in human volunteers to answer specific health queries. Fastidiously conducted clinical trials square measure quickest and safest thanks to realizing treatment that employment in individuals and thanks to improving health. Play a crucial role in guaranteeing that patient to be provided the safe drug. The Pharmacovigilance has been recognizing to play a crucial role in the rational use of the drug by providing data concerning the adverse impact possess by drug normally population. The information of drug Adverse Drug Reaction (ADRs) are often increased by numerous suggests that such information studies, intensive observation, spontaneous reportage and different new method at dictatorial and scienti...

International journal of health sciences

The World Health Organization (WHO) defines Pharmacovigilance as the science & activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The National Pharmacovigilance Programme (NPVP) was launched in 2004 with World Bank funding till 2009, which was renamed as Pharmacovigilance Programme of India (PvPI). With advancement in the field of science and technology, India is emerging as a hub for clinical trials and new drug development, which challenges the monitoring of safety concerns in the use of new drugs. It has been difficult to identify or track the adverse drug reactions (ADRs) that occur in the patients due to polypharmacy, use of over the counter (OTC) preparations, change in physician etc. Hence the national programme has gained importance in our country off late. Yet it is observed that the importance of this programme is not realized by all health care professionals. Therefore, to support & strengthen t...

Asian Journal of Research in Medical and Pharmaceutical Sciences

The harm(s) a drug may cause may not be known at the time it gains market authorisation. Drug regulatory agencies weigh the benefits that the drug presents against the potential harms it could pose and allow it to be marketed if it is believed that the drug has a favourable risk-benefit ratio. Regulatory agencies then evaluate the drug's risk profile as it is used on a large scale and institute remedial measures if found necessary. Data is needed in establishing that an Adverse Event (AE) accompanying drug use is, in fact, an Adverse Drug Reaction (ADR), and in carrying out the functions outlined above. This paper explores some of the issues involved, the importance of data in the work of regulatory agencies and draws attention to the need for all to facilitate the work of regulatory agencies.

INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES, 2024

Pharmacovigilance, a vital component of the healthcare system, has evolved over 170 years to become a structured activity aimed at monitoring the risks and benefits of drugs. This article explores the historical milestones in the evolution of pharmacovigilance, from early clinician warnings in scientific journals to the establishment of electronic registries. Through vigilant monitoring of drug side effects, pharmacovigilance has made substantial contributions to preventing and addressing potential problems promptly. However, emerging challenges necessitate ongoing evolution in data collection and analysis methods to identify new side effects and drug interactions. Global pharmacovigilance systems aim to regulate the risk-to- benefit ratio of medicinal drugs, enhancing patient safety and overall quality of life. The article highlights the significant transformation in European Pharmacovigilance with the establishment of the European Medicines Agency (EMA) in 1995 and the introduction of Surveillance in 2001. Directive 2010/84/EU in 2012 brought crucial changes, including modified adverse drug reaction definitions, increased patient involvement, and enhanced transparency. A literature survey emphasizes the global perspective on pharmacovigilance. Studies from India underscore the importance of implementing Good Pharmacovigilance Practice (GPP) to improve regulatory compliance, clinical trial safety, and post-marketing surveillance. The challenges and future perspectives of pharmacovigilance in India are discussed, emphasizing the need for a well-functioning system. The historical evolution of pharmacovigilance in India is detailed, starting with revisions to Schedule Y in 2000 and the establishment of the National Pharmacovigilance Program in 2004-05. Despite India's growing prominence in clinical trials and pharmaceuticals, challenges like low ADR reporting rates persist. Case studies illustrate the practical application of pharmacovigilance, showcasing its role in identifying adverse drug events, conducting thorough reviews, and ensuring patient safety. The article concludes with recommendations for strengthening India's pharmacovigilance system, addressing challenges, and emphasizing the importance of integrating patient perspectives. In the future, the focus should be on developing a robust pharmacovigilance system that identifies emerging adverse drug reactions, integrates patient perspectives, and incorporates good pharmacovigilance practices into regulatory processes.

EPRA international journal of research & development, 2023

Pharmacovigilance, or PV, is the process of continuously monitoring pharmaceuticals once they are put on the market in order to evaluate and enhance their safety profile. Increasing the number of adverse drug reactions (ADRs) that are spontaneously reported is the primary goal in order to collect a wide range of data. The World Health Organization (WHO) defined pharmacovigilance as t he science and set of procedures concerning the identification, assessment, comprehension, and rejection of negative effects or problems associated with various drugs in nursing. A clinical test may involve an analysis study involving human subjects in order to address particular health questions. Carefully carried out clinical trials are the fastest and safest methods because they help individuals receive treatments that work and because they improve health. Pharmacovigilance, which provides information on the negative effects that the drug-using population typically experiences, is acknowledged to be essential to the sensible use of pharmaceuticals. Adverse drug reactions (ADRs) are becoming more and more common, and various methods, including scientific and administrative research, indepth observation, impromptu reporting, and information studies, are being developed with the goal of enhancing pharmacovigilance. Because assessment procedures contain some subjective judgements, integrator reliability is frequently low. In summary, there is presently no well recognized mechanism for assessing casualties from ADRs.

World Medicine Situation 2011

International Research Journal of …

Abstract: Pharmacovigilance procedures are necessary for evaluation of medicines. Thus Pharmacovigilance aims at detection, assessment and prevention of adverse effects or of any possible drug related problems. Reports of suspected adverse drug reactions (ADRs) ...