Zenodo (CERN European Organization for Nuclear Research), Jun 1, 2021
The voluntary reporting of adverse drug reactions requires continuous stimulation and motivation.... more The voluntary reporting of adverse drug reactions requires continuous stimulation and motivation. It is achieved by the development of a positive approach towards pharmacovigilance among healthcare professionals so that adverse reaction reporting becomes an accepted and understood routine. In summary, the various strategies developed and made available in India to stimulate reporting, promotion, educational interventions/ awareness program/academics, hospital-based ADRs reporting, establish a culture of reporting. These exclusive strategies progress the reporting rate in India by altering the mindset of healthcare professionals, undergraduates, and consumers towards safety reporting.
Journal of pharmacy practice and community medicine, May 21, 2022
This is an open access article distributed under the terms of the Creative Commons Attribution-No... more This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License BACKGROUND An adverse drug reaction (ADRs) affects the majority of population under medications worldwide. ADRs cause significant change in morbidity and mortality, and may increase the economic burden on the healthcare system. As per World Health Organization (WHO), Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects and all other problems related to medicines. 1 Passive surveillance/voluntary reporting of spontaneous adverse events from healthcare providers (HCPs and consumers following the administration of a pharmaceutical product have been usually adopted to monitor the product safety. Various reporting systems have been adopted in different countries to report ADR's to National Pv centre, such as cohort event monitoring system and spontaneous report monitoring system (also known as stimulated, enhanced, and targeted). These methods are significant to identify the quantitative aspects of drug safety, to better recognize highexposure groups and specific risk factors, to distinguish ADRs related with particular medications and in a cohort of patients. Cohort event monitoring (CME) system is one of the oldest methods of reporting ADR's. Targeted spontaneous Reporting (TSR) is an innovative technique of PV system that harmonizes findings of conventional safety monitoring systems. The newly established method TSR system frames on spontaneous reporting system by accumulating features of CME, therefore which interns useful in establishing an economical model of collecting information on suspected ADR's. This method is implemented for the identification of ADRs in clinical practice on which minimal data already existed with PV system, which requires investigation on existing spontaneous reports. Additionally it covers the reactions occurring from drug-drug interactions or drug related effects among high risk populations to improve the understanding of the potential risks as well as to provide a support for adequate management of patients and supervision of medications, furthermore helpful in consequent changes in clinical practice. National Pharmacovigilance Programme mainly relies on the voluntary reporting or spontaneous reporting from various stakeholders. 2 The major source of information mainly obtained from spontaneous reporting systems. 3 The drug safety reports helpful in identifying safety alerts and to monitor rational use of medicines in public. 4 Identification of signals at early stage results in preventing potential risk, further collateral research, regulatory decision and updating product safety information 5-6 Methods of Pharmacovigilance Systems Spontaneous reporting system (SR) 2,6 This is the widely adopted system of PV which is often referred to as "voluntary" reporting. Spontaneous reporting depends on the reporters being educated and motivated to record and submit their observations. Training should be given to all the practicing healthcare professionals and members of the community in sensitizing the reporting culture in terms
Journal of Pharmacovigilance and Drug Research, 2021
Introduction: The voluntary reporting of adverse drug reactions requires continuous stimulation a... more Introduction: The voluntary reporting of adverse drug reactions requires continuous stimulation and motivation. Methods: It is achieved by the development of a positive approach towards pharmacovigilance among healthcare professionals so that adverse reaction reporting becomes an accepted and understood routine. Results: In summary, the various strategies developed and made available in India to stimulate reporting, promotion, educational interventions/ awareness program/academics, hospital-based ADRs reporting, establish a culture of reporting. Conclusions: These exclusive strategies progress the reporting rate in India by altering the mindset of healthcare professionals, undergraduates, and consumers towards safety reporting.
Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India
Perspectives in clinical research
The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmaco... more The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016. This study aims to highlight the drug safety alerts issued by NCC-PvPI from March 2016 to June 2017 and urgent need for further monitoring by adopting targeted spontaneous reporting (TSR) methodology at AMCs and its impact on the NCC's drug safety database, i.e., VigiFlow in India. A retrospective analysis was done for the reported unlisted ADRs by various AMCs to PvPI through VigiFlow, i....
Radiopharmaceutical preparations are the important pharmaceutical dosage forms used for the diagn... more Radiopharmaceutical preparations are the important pharmaceutical dosage forms used for the diagnosis and therapeutic purposes. Various pharmacopoeias are having methods for the quality control of these preparations in the form of monographs. Indian Pharmacopoeia (IP) also included these monographs in IP 2014 first time with the help of an experts' group on radiopharmaceutical, drawing expertise from elite stakeholder institutions and the core team of Indian Pharmacopoeia Commission. Since then, these standards are regularly updated through the IP addendum and bringing out new edition of IP. IP is a book of official methods as per Drugs and Cosmetic Act, 1940. These standards can be used in government laboratories, private laboratories, or academia in India and abroad. This review provides an overview of the journey of radiopharmaceuticals' standard setting in IP. A comprehensive comparative information of regulatory perspectives of radiopharmaceuticals in different jurisdictions such as the US, EU, and India is also presented.
Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India
Perspectives in clinical research
The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmaco... more The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016. This study aims to highlight the drug safety alerts issued by NCC-PvPI from March 2016 to June 2017 and urgent need for further monitoring by adopting targeted spontaneous reporting (TSR) methodology at AMCs and its impact on the NCC's drug safety database, i.e., VigiFlow in India. A retrospective analysis was done for the reported unlisted ADRs by various AMCs to PvPI through VigiFlow, i....
Adverse drug reactions at an addiction psychiatry center: A cross-sectional analysis
Journal of Pharmacology and Pharmacotherapeutics
Targeted spontaneous reporting on drug safety alerts issued by pharmacovigilance programme of India: A new origin of pharmacovigilance in India
Journal of Pharmacology and Pharmacotherapeutics
Pharmacovigilance in drugs used in the treatment of drug dependence
Mammalian spermiogenesis is of considerable biological interest especially due to the unique chro... more Mammalian spermiogenesis is of considerable biological interest especially due to the unique chromatin remodeling events that take place during spermatid maturation. Here, we have studied the expression of chromatin remodeling factors in different spermatogenic stages and narrowed it down to bromodomain, testis-specific (Brdt) as a key molecule participating in chromatin remodeling during rat spermiogenesis. Our immunocytochemistry experiments reveal that Brdt colocalizes with acetylated H4 in elongating spermatids. Remodeling assays showed an acetylation-dependent but ATP-independent chromatin reorganization property of Brdt in haploid round spermatids. Furthermore, Brdt interacts with Smarce1, a member of the SWI/SNF family. We have studied the genomic organization of smarce1 and identified that it has two splice variants expressed during spermatogenesis. The N terminus of Brdt is involved in the recognition of Smarce1 as well as in the reorganization of hyperacetylated round sper...
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