Journal of Pharmacovigilance and Drug Research 2021-06-06T06:11:29+00:00 Journal of Pharmacovigilance and Drug Research Open Journal Systems <p class="has-text-align-justify has-text-color" style="text-align: justify;">Journal of Pharmacovigilance and Drug Research (JPADR) provides a platform for pharmacovigilance professionals to share their research experience with all the researchers, scientists, physicians, scientists across the globe regarding adverse events associated with a particular drug.</p> <p class="has-text-align-justify has-text-color" style="text-align: justify;">JPADR is a quarterly journal with 4 issues per year. The received manuscripts from all the researches undergo a peer-review process prior to its publications. As per the quality standard of our articles, we accept a manuscript with less than 10 % similarity passing through plagiarism software.</p> <p class="has-text-align-justify has-text-color" style="text-align: justify;">We accept manuscripts which could be a review work, short notes, original research, case studies. It could be accepted from academic institutions, hospitals and pharmaceutical industries. The pharmacovigilance professionals working for other institutions, such as contract research organizations (CROs), clinical research centres, and software companies can also submit their research work to protect the patients form unexpected adverse drug reactions.</p> <p class="has-text-align-justify has-text-color" style="text-align: justify;">Please read carefully the instructions for the author prior to submitting manuscripts for the safety of drugs as well as patients.</p> <p class="has-text-align-justify has-text-color" style="text-align: justify;"><span class="has-inline-color">Filter your manuscripts through the software such as Grammarly, citation machine, cite this for me to generate quality manuscripts, prior to submitting it to us. Thank you.</span></p> Story of the biggest vaccination drive in the world so far 2021-06-06T05:54:02+00:00 Maya Sharma <p>India is called the 'Vaccine Manufacturer of the World', as it produces approx. 60 % of the world's vaccines. UNICEF depends heavily on economically produced vaccines in India for its global health programs, especially in low-income countries. The reasons which enabled India to become the manufacturing might have been fairly simple: low cost of conducting clinical trials, low cost of production, preference of earning from large scale usage rather than profit on each unit, and most importantly a big talent pool available at fraction of cost of Western World. Hence India became the global leader of generic drugs and vaccines.</p> 2021-06-01T00:00:00+00:00 Copyright (c) 2021 Maya Sharma Global Pharmacovigilance, challenges, and future considerations: West globe and East globe 2021-06-06T05:56:53+00:00 Jyoti Sushma Gadhade Rajesh Sudhakar Hiray <p style="text-align: justify;"><span lang="EN-IN">Pharmacovigilance (PV) plays a consequential role in the drug regulatory system and is a constantly evolving multifaceted field. In the process of carrying out its effective management, the PV system does undergo a lot of challenges on a global pitch. PV system is well developed in the western globe (United States,&nbsp; United Kingdom,&nbsp; Germany) while the east globe (e.g.: India) is still in the evolving stage. Major discrepancies include different regulatory authorities for each nation with different forms for ADR reporting and also different timelines. To mention a few; there is a regulatory gap because of the continuously evolving regulations and business processes, it is difficult to comply with the diverse regulations effectively; gross underreporting in the east as compared to the west; increased concern about the safety and potential toxicity of traditional Chinese herbs in the east; self-medication; linguistic barrier, etc. Steps like harmonization of regulation by drafting guidelines that are uniform globally; leveraging digital technologies to optimize ADR reporting; meticulous and timely reporting; inclusion of PV in the curriculum etc. can be employed. While PV has witnessed substantial development over the years, areas of discrepancies need to be identified to build a seamless PV system. Need for an effective revolutionary roadmap to tackle all the hindrances to fortify its harmonious functioning.</span></p> 2021-06-01T00:00:00+00:00 Copyright (c) 2021 Jyoti Sushma Gadhade, Rajesh Sudhakar Hiray Pharmacovigilance in generic Indian pharmaceutical industries - Need of the moment 2021-06-06T05:59:13+00:00 Porus Rajpurohit Manoj Suva Hardik Rajpurohit Yogesh Singh <p style="text-align: justify;"><span lang="EN-IN">The Pharmacovigilance department is liable for monitoring the safety of medicines during clinical trials and normal clinical use. The necessity of the Pharmacovigilance department is an utmost requirement for effective regulations of the drug approval process and conscious pre and post-approval vigilance of the undesired effects, especially in India. In the light of the regulatory notification GSR 287(E) dated on 8th march 2016 by CDCSO, it has become clear that it is necessary to take measures to set up and improve the operation of the pharmacovigilance of medicinal products for human use in pharmaceutical companies.&nbsp; The regulators have also developed and posted Guidance document for marketing authorization holders (MAH) for Indian marketers and made clear that the MAH should be responsible for continuously monitoring the safety of its medicinal products for human use, for updating the health authorities of any changes related to the drug, and for ensuring that the product information is kept up-to-date. MAH should record all suspected adverse reactions occurring in the country, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of the post-authorization study. According to the Regulatory Guidance document, MAH is also responsible for the submission of the information on suspected adverse reactions of a newly approved drug or applicable product, in form of periodic safety update reports (PSURs), to the competent authorities.</span></p> 2021-06-01T00:00:00+00:00 Copyright (c) 2021 Porus Rajpurohit, Manoj Suva, Hardik Rajpurohit, Yogesh Singh Stimulated adverse drug reaction reporting in Pharmacovigilance: Indian Perspectives 2021-06-06T06:03:49+00:00 Anusha Thota Siddharth Sarkar Snehil Guptha Prasad Thota <p style="text-align: justify;"><span lang="EN-IN">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.</span></p> 2021-06-01T00:00:00+00:00 Copyright (c) 2021 Anusha Thota, Siddharth Sarkar, Snehil Guptha, Prasad Thota An overview of the worldwide master key for pharmacovigilance and its role in India 2021-06-06T06:06:26+00:00 Janmejay Pant Harneet Marwah Ripudaman M Singh Subhajit Hazra <p style="text-align: justify;"><span lang="EN-IN">Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this. The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.</span></p> 2021-06-01T00:00:00+00:00 Copyright (c) 2021 Janmejay Pant, Harneet Marwah, Ripudaman M Singh, Subhajit Hazra Assessment of Adverse Drug Reactions of Psychopharmacological Drugs in Patients of Psychiatric Disorders 2021-06-06T06:08:58+00:00 Rani Kumari Rachna Gupta Manjeet Singh Bhatia Suresh Kumar Gupta <p style="text-align: justify;"><span lang="EN-IN">Psychopharmacological drugs are used in the treatment of different types of psychotropic disorders. These drugs are associated with a variety of adverse drug reactions (ADRs). The ADRs due to psychopharmacological drugs are a significant cause of mortality and morbidity. The current study assessed the adverse drug reactions of psychopharmacological drugs in patients with psychiatric disorders. This study was a retrospective study. All ADR forms related to psychopharmacological drugs that were reported to the pharmacovigilance center, UCMS, and GTB Hospital,&nbsp; between December 2019 to February 2020, were assessed to identify the incidence and nature of important ADRs. Causality assessment was done by WHO Uppsala Monitoring Centre Global Introspection Method. A total of 150 ADR forms were analyzed. Females (60.66 %) experienced more ADRs than males (39.33 %). ADRs were most commonly reported in the age group of 18-28 years followed by 29-39 years. Depression was the most common diagnosis in patients with psychiatric disorders. Dizziness was the most common ADR followed by headache and insomnia. Escitalopram (12.21 %) was the most commonly implicated drug causing ADRs followed by clonazepam (9.92 %). As per the WHO causality assessment method, 77 % of ADRs were possible and 23 % were probable. Therefore, early detection and awareness of ADRs are important to enable health professionals to perform alterations in the prescribed drug treatment to prevent or reduce the adverse effects due to psychotropic drugs. This will improve patient care and safety as well as promote rational use of drugs.</span></p> 2021-06-01T00:00:00+00:00 Copyright (c) 2021 Rani Kumari, Rachna Gupta, Manjeet Singh Bhatia, Suresh Kumar Gupta Pharmacovigilance study in geriatric patients of a tertiary care hospital 2021-06-06T06:11:29+00:00 Rajalakshmi Rukmangathen Vasundara Devi Brahmanapalli <p style="text-align: justify;"><span lang="EN-IN">The aim was to assess, categorize and analyze the adverse drug reactions among geriatric patients in a tertiary care hospital.&nbsp; All adverse drug reactions of geriatric patients reported at the Adverse Drug Reaction Monitoring Center, Sri Venkateswara Medical College, Tirupati, under the Pharmacovigilance programme of India, during September 2016 and January 2018 were identified and evaluated. A retrospective analysis was carried out for ADR pattern, drug groups, organ systems implicated in suspect ADR, demographic profile, causality (as per the WHO–UMC scale), severity (Hartwig and Seigel scale), and preventability (Schumock and Thornton criteria) of a said drug. A total of 120 ADRs were received among geriatric patients. Most of the ADRs occurred in male geriatrics (55.83 %) and (34.2 %) occurred in the age group of 60- 64 years. Antibiotics comprised the major group of drugs causing ADRs (18.3 %). ADRs related to gastrointestinal systems were most common with 31.7 % followed by skin disorders (15 %) and central nervous system disorders (13.3 %). As per the causality assessment scale, the majority of adverse drug reactions were found to be possible (51.7 %). There were 60.8 % of reactions being mild and 39.2 % were moderate reactions as per severity scale. The majority of the adverse drug reactions were non-serious (33 %) and in the serious category, 27.5 % of ADRs required intervention to prevent permanent damage.</span></p> 2021-06-01T00:00:00+00:00 Copyright (c) 2021 Rajalakshmi Rukmangathen, Vasundara Devi Brahmanapalli