Journal of Pharmacovigilance and Drug Research <p>The Journal of Pharmacovigilance and Drug Research (JPADR) is the official publication of the Global Pharmacovigilance Society. This is an international, open access, and peer-reviewed scientific journal. It focuses on pharmacovigilance studies and their associated topics such as adverse drug reaction, drug clinical trials, drug effectiveness and efficacy, drugs risk management, as well as all aspects related to the safe use of drugs.</p> <p>The JPADR is oriented to researchers, professors, students, and practitioners from both the pharmaceutical industry sector, as well as the wide range of health and medicine arenas. The journal’s objective is to establish a formal platform for communicating the research results on pharmacovigilance.</p> Global Pharmacovigilance Society en-US Journal of Pharmacovigilance and Drug Research 2582-7235 The need for Quality <p style="text-align: justify;">Hearing about pharmacovigilance (PV) and patient safety, both non-professionals and professionals tend to focus only on the safety aspect of the story; most of us were guilty of that at a point in our careers, but what about Quality? Where does it fit, and how does it help?</p> <p style="text-align: justify;">The "holy" triangle includes safety, efficacy and also quality. Undoubtedly, the quality element should be built into PV to ensure high standards, efficient workload management, the safety of our patients and public health. This article aims to guide readers through the starting points of integrating Quality into PV related processes, focusing on Standard operating procedures (SOPs).</p> Erika Barbarosie Copyright (c) 2022 Erika Barbarosie 2022-06-01 2022-06-01 3 2 1 3 10.53411/jpadr.2022.3.2.1 Safety and tolerability of antipsychotic drugs in pediatric patients <p style="text-align: justify;"><strong>Introduction</strong>: Second-generation antipsychotics have seen a significant surge in use for a variety of pediatric psychiatric problems over the last decade, typically as off-label prescriptions. Although they were previously regarded to be safer than older, first-generation antipsychotics, owing to a lower incidence of neurological side effects, current research has raised serious concerns about their metabolic, endocrinological, and cardiovascular side effects.</p> <p style="text-align: justify;"><strong>Methods</strong>: The Cochrane Library, PubMed, Embase, and PsychINFO databases were searched for scientific articles between the periods 2009 and 2022. We included studies that reported pediatric patients taking second-generation antipsychotic drugs. The obtained information was evaluated, compiled, analyzed, interpreted, and conclusions were reached</p> <p style="text-align: justify;"><strong>Results</strong>: In total, 45 articles were reviewed. The most common and troublesome adverse effects were metabolic, with increasing evidence of a higher risk of type 2 diabetes mellitus. Furthermore, findings showed that different second-generation antipsychotics may have different safety profiles.</p> <p style="text-align: justify;"><strong>Conclusion</strong>: In this review, we discussed the safety and tolerability of second-generation antipsychotics in pediatric patients, as well as active monitoring measures that could help pediatricians and child psychiatrists prevent, detect, and manage side effects. The benefits of relieving often severe and debilitating manic, psychotic, and violent symptomatology must be weighed against the various risks of adverse effects associated with individual antipsychotic drugs in pediatric patients when making treatment decisions. Any antipsychotic treatment should begin and end with a consideration of side effects, as well as food and lifestyle advice. Patients and their families should be included in a risk-benefit analysis when considering an antipsychotic treatment. To improve patient outcomes, routine, proactive monitoring of side effects is required.</p> Nabih Lawand Samaa Al Tabbah Copyright (c) 2022 Nabih Lawand, Samaa Al Tabbah 2022-06-01 2022-06-01 3 2 4 10 10.53411/jpadr.2022.3.2.2 Drug development hit by war <p style="text-align: justify;"><strong>Introduction: </strong>Drug development is the process by which academic, pharmaceutical, or government laboratories identify or screen new chemical entities to find potentially active pharmacological compounds and bring them to the market. This process is undoubtedly the heart and soul of modern medicine. War is an incidental condition that can disrupt the drug development pipeline and clinical research. During the current Russia-Ukraine war, multiple sanctions are being imposed on Russia which is disrupting the supply chain and slowing down the process of drug development.</p> <p style="text-align: justify;"><strong>Objective: </strong>This review was done to understand how war and international conflicts affect the global drug development process.</p> <p style="text-align: justify;"><strong>Methods: </strong>Information was obtained by reviewing the data from previously published news material. We used PubMed, Google Scholar, Web of Science, Medline, and Embase as our search engines and keywords like (Ukraine, Russia, clinical trial, pharmaceutical industry, war, and drug development). In total, we reviewed 74 articles, and the obtained information was interpreted, compiled, evaluated, reassembled, deconstructed and conclusions were reached.</p> <p style="text-align: justify;"><strong>Conclusion: </strong>In the past despite multiple wars, mankind has not learned from their past mistakes. The pharmaceutical industry should form mitigation plans so that in the time of crisis other options are available for drug discovery and clinical research.</p> Hara Prasad Mishra Ayush Goel Sahil Kumar Mihir Chauhan Mrinal Patnaik Imaad Rehman Copyright (c) 2022 Hara Prasad Mishra, Ayush Goel, Sahil Kumar, Mihir Chauhan, Mrinal Patnaik, Imaad Rehman 2022-06-01 2022-06-01 3 2 11 15 10.53411/jpadr.2022.3.2.3 Exploring position of colchicine in management of COVID 19 – A systematic review <p style="text-align: justify;"><strong>Introduction:</strong> One of the goals of managing COVID 19 patients is controlling inflammatory responses, which are majorly responsible for morbidity and mortality associated with SARS CoV 2 infection. A novel approach to address inflammation could be Colchicine. It invariably decreases pulmonary complexities, showing antimitotic action, causing metaphase arrest by inhibiting microtubule and spindle formation, and is effective in reducing granulocyte migration, ultimately reducing inflammation.</p> <p style="text-align: justify;"><strong>Method:</strong> For this systemic review, literature was searched using PubMed, Embase, Cochrane Central, medRxiv, and The keywords used were – COVID 19, colchicine, SARS-CoV-2, and clinical outcome. Studies published between January 2020 and October 2021 were evaluated and screened to identify those that had reported the effect of colchicine in SARS CoV 2 infected patients and to assess clinical outcomes including mortality, intensive care unit (ICU) admissions, or mechanical ventilation.</p> <p style="text-align: justify;"><strong>Results and Discussion:</strong> In this systematic review among 8 quantitative clinical researchers, it was observed that colchicine administration was related to improved clinical outcomes in COVID 19 patients, without statistical significance.</p> <p style="text-align: justify;"><strong>Conclusion:</strong> The mortality risk of COVID-19 patients can be reduced by colchicine. Need more prospective clinical researches which could help to evaluate the efficacy of colchicine to treat COVID-19 patients in different stages of the disease, including post-hospitalization and long-term care follow-up.</p> Shambo Samrat Samajdar Shrestha Dutta Aneek Ghosh Shatavisa Mukherjee Jayanta Sharma Anwesha Behera Oyendrilla Mitra Ishanee Das Sharma Mohojit Chakraborty Santanu K Tripathi Copyright (c) 2022 Shambo Samrat Samajdar, Shrestha Dutta, Aneek Ghosh, Shatavisa Mukherjee, Jayanta Sharma, Anwesha Behera, Oyendrilla Mitra, Ishanee Das Sharma, Mohojit Chakraborty, Santanu K Tripathi 2022-06-01 2022-06-01 3 2 16 21 10.53411/jpadr.2022.3.2.4 Anti-viral activity of Withania somnifera phytoconstituents against corona virus (SARS-COV-2) <p><strong>Introduction</strong>: Traditional medicine practitioners use natural active compounds found in medicinal plants to treat a variety of diseases. Withania somnifera, also known as Ashwagandha, Winter Cherry, and Indian Ginseng, is one such herb that has been used to cure a variety of ailments since the time of Ayurveda, India's ancient medical system. The Solanaceae family includes Withania somnifera.</p> <p><strong>Method:</strong> The exhaustive literature survey has been done via various search engines, review articles, research articles, google scholar, PubMed, internet. According to recent investigations, Withanolides, a bioactive ingredient of Withania somnifera, have shown therapeutic efficacy in decreasing the intensity of SARS-CoV-2 and in providing medical care and attention to individuals suffering from COVID-19. Free-radical scavenging is another feature of Ashwagandha. This review article contains information regarding phytochemistry and antiviral activity against coronavirus.</p> <p><strong>Results:</strong> In-silico investigations have revealed that it has a high binding affinity for the ACE2–RBD interface, which could prevent SARS COV 2 from infecting cells. In India, ashwagandha is available as a liquid, tablet, or powder. This review article's aim is to provide all the information and research work that should be done by researchers recently against SARS COVID-19.</p> <p><strong>Discussion:</strong> Due to its immune-modulatory, anti-stress, and antiviral characteristics, Ashwagandha has been chosen. The aim of the review article is to review ‘the anti-viral activity of Withania somnifera phytoconstituents against coronavirus (SARS-COV-2).</p> Shweta Parihar Copyright (c) 2022 Shweta Parihar 2022-06-01 2022-06-01 3 2 22 26 10.53411/jpadr.2022.3.2.5 Knowledge, attitude and practice towards adverse drug events reporting among graduating health science students of college of health sciences, Addis Ababa University, Ethiopia <p><strong>Introduction</strong><strong>: </strong>The knowledge, attitude, and practice of the health sciences students are crucial for their future monitoring and reporting of adverse drug events as professional responsibility.</p> <p><strong>Aim:</strong> To describe the knowledge, attitude, and practice of graduating medicine and pharmacy students at the College of Health Sciences, Addis Ababa, Ethiopia</p> <p><strong>Method: </strong>This study was based on a cross-sectional study design. Data were collected through a structured and pilot-tested questionnaire. The data was entered and analyzed using SPSS version 20. The descriptive statistics such as frequency, mean, standard deviation, percentages computed, and the association between variables were conducted using Chi-square. The p-value of &lt; 0.05 was taken as statistically significant.</p> <p><strong>Result:</strong> A total of 140 students were included in this study. The majority of the participants were medicine students 82 (58.6 %) and males 84 (60 %). Most of the respondents, 106 (75.7 %) knew the ADE reporting system, and 126 (98.6 %) drug safety monitoring is important. However, about half of the students 65 (46.4 %) were not aware of the national ADE reporting system. During clerkships 57 (40.7 %) participants encountered at least once ADE, but only 23 (16.4%) of them had reported it. Graduating pharmacy students have better knowledge on “pharmacovigilance” (84.5 % Vs 43.9 %, p &lt; 0.001) but medicine students were better at reporting the encountered ADE (22.0 % Vs 8.6 %, p = 0.04).</p> <p><strong>Conclusion: </strong>The graduating medical interns and pharmacy students have a positive attitude towards ADEs. However, they have a low level of knowledge and practice about voluntary adverse drug events reporting.</p> Mamo Senbeta Hiluf Maldey Melak Gedamu Copyright (c) 2022 Mamo Senbeta, Hiluf Maldey, Melak Gedamu 2022-06-01 2022-06-01 3 2 27 33 10.53411/jpadr.2022.3.2.6 Lymphoproliferative skin lesion as a previously unreported adverse event detected in a patient receiving mSTR TB treatment <p><strong>Case Presentation:</strong> This case report presents an unreported adverse event detected when conducting pharmacovigilance activity among the patients’ cohort receiving short, modified, all-oral treatment regimens (mSTR) for rifampicin-resistant tuberculosis (TB). Lymphoproliferative skin lesion was diagnosed histologically.</p> <p><strong>Results:</strong> The withdrawal clinical response and re-challenge positive test were detected, and the causal relationship was defined as “probable”.</p> <p>&nbsp;</p> Hakob Atshemyan Naira Khachatryan Artak Manukyan Anush Khachatryan Alvard Poghosyan Copyright (c) 2022 Hakob Atshemyan, Naira Khachatryan, Artak Manukyan, Anush Khachatryan, Alvard Poghosyan 2022-06-01 2022-06-01 3 2 34 37 10.53411/jpadr.2022.3.2.7 Safety profile and adverse drug reaction with causality assessment of Dapagliflozin in diabetes <p style="text-align: justify;"><strong>Introduction:</strong> Diabetes mellitus is a metabolic disorder characterized by high blood sugar levels and may damage nerves, kidneys, and other organs in the body. Currently, there are different anti-diabetic drugs prescribed by the physician to treat diabetes mellitus. Among them, dapagliflozin is now commonly prescribed for reducing blood glucose levels along with kidney protection.</p> <p style="text-align: justify;"><strong>Objective:</strong> The primary objective of the study was to describe adverse drug reaction (ADR) of dapagliflozin.</p> <p style="text-align: justify;"><strong>Methods:</strong> This is a clinical observational study of an 81-year-old male patient with a hyperglycemic condition. Here the patient case study was done for the safety purpose in diabetes mellitus.</p> <p style="text-align: justify;"><strong>Result</strong>: In this case of dapagliflozin intake the patient suffered from itching and rashes with redness in the bilateral external earlobes. The dermatologist labeled it as polychondritis of the ear cartilage. Recurrence of the symptoms when the patient was rechallenged with dapagliflozin. As per the dechallenge and rechallenge done in the patient, the withdrawal of dapagliflozin freed up this particular side effect.</p> <p style="text-align: justify;"><strong>Conclusion</strong>: The patient was detected with an adverse drug reaction due to the intake of dapagliflozin. So, any administration of dapagliflozin should be followed up with possible polychondritis or itching and rashes in the skin in general and the ear lobe in particular.</p> Prabhudatta Mohapatra Karmajeet Rath Priyabrata Pattanayak Copyright (c) 2022 PRABHUDATTA MOHAPATRA, Karmajeet Rath, Priyabrata Pattanayak 2022-06-01 2022-06-01 3 2 38 40 10.53411/jpadr.2022.3.2.8 Safety profile and adverse drug reactions with causality assessment of Ticagrelor in Myocardial Infraction <p><strong>Introduction:</strong> Antiplatelet medications are the most commonly used first-line therapy in acute coronary syndrome (ACS), particularly those undergoing percutaneous coronary intervention (PCI).P2Y12 is one of the two platelet receptors for adenosine diphosphate (ADP), which play a very important role in platelet function and thrombus formation.</p> <p><strong>Method:</strong> In this article, we present 2 case reports of patients, showing severe symptoms of dyspnoea. Then we describe possible mechanisms of these complications when switching Ticagrelor to other antiplatelet drugs, and also make therapeutic recommendations for Ticagrelor-associated therapy based on what we know presently to deal with such symptoms.</p> <p><strong>Results:</strong> In ACS patients, with existing respiratory disorders, Dyspnoea can be fatal. Clinical studies have shown that reduced lung function or low EF is not harmful contraindications for Ticagrelor.</p> <p><strong>Discussion:&nbsp;</strong>However, these groups of patients should be monitored closely after administration of Ticagrelor.</p> S. P. Santhosh Kumar Shangavi V Abisha R. S. Aiswaria M. S. Abburi Lalitha Nandini Abitha Aravindakshan Amritha Harish N Copyright (c) 2022 S. P. Santhosh Kumar , Shangavi V, Abisha R S, M. S. Aiswaria , Abburi Lalitha Nandini, Abitha Aravindakshan, Amritha Harish N 2022-06-01 2022-06-01 3 2 41 45 10.53411/jpadr.2022.3.2.9