Journal of Pharmacovigilance and Drug Research https://jpadr.com/index.php/jpadr <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 COVID vaccination in Indian children: Current status and considerations https://jpadr.com/index.php/jpadr/article/view/57 Maya Sharma Copyright (c) 2021 Maya Sharma https://creativecommons.org/licenses/by-nc-nd/4.0 2021-12-01 2021-12-01 2 4 1 2 10.53411/jpadr.2021.2.4.1 Impact of National pharmacovigilance week: A masterstroke by IPC-PvPI https://jpadr.com/index.php/jpadr/article/view/55 <p>Abstract is not applicable as it is an editorial article.&nbsp;</p> Shiva Murthy Nanjundappa Chinmaya Mahapatra Copyright (c) 2021 Dr Shiva Murthy Nanjundappa, Chinmaya Mahapatra https://creativecommons.org/licenses/by-nc-nd/4.0 2021-12-01 2021-12-01 2 4 3 5 10.53411/jpadr.2021.2.4.2 Strategies for automating pharmacovigilance adverse event case processing https://jpadr.com/index.php/jpadr/article/view/52 <p><strong>Introduction:</strong> In 2020, the U.S. Food &amp; Drug Administration received reports of 2.2 million adverse events, which is a 350% increase since 2010 with an associated increase in pharmaceutical companies' pharmacovigilance (PV) operational cost. Guided by the task technology fit model as the conceptual framework, the purpose of this qualitative single case study was to explore strategies used by PV systems leaders to implement innovative technology solutions. The objective of the study was to develop a system model to explore strategies to implement innovative technology to automate AE detection, processing, and reporting.</p> <p><strong>Methods:</strong> Data were collected using semistructured interviews and company data to address the research question on strategies to implement innovative technology solutions to automate adverse events case processing. The collected data was analyzed using 5-step data analysis, compiling, disassembling, reassembling, interpreting data, and concluding the findings.</p> <p><strong>Results:</strong> The implications for positive social change include the potential to identify strategies in making pharmaceutical medicines safer for human consumption.</p> <p><strong>Conclusions:</strong> PV leaders can redirect the savings from PV operations in terms of cost and workforce tasks towards investing in the actual PV tasks like benefit-risk assessments of products; thereby, improving patient outcomes and making the products more efficacious and safer for human use.</p> Mythily Easwar Kenneth Gossett Manish Shashi Copyright (c) 2021 Mythily Easwar, Kenneth Gossett, Manish Shashi https://creativecommons.org/licenses/by-nc-nd/4.0 2021-12-01 2021-12-01 2 4 6 13 10.53411/jpadr.2021.2.4.3 Medical treatment options available for mucormycosis https://jpadr.com/index.php/jpadr/article/view/49 <p><strong>Introduction: </strong>Mucormycosis is known as a rapidly progressive and invasive lethal fungal infection. The predisposing factors known to potentiate this fungal infection are diabetes mellitus, primary or secondary immunodeficiency, etc. The clinical presentation of these cases may vary from involvement of localized skin infection to disseminated systemic infection.</p> <p><strong>Methods:</strong> In this article, an attempt was made to review the therapeutic guidelines released by European Committee for Antimicrobial Susceptibility Testing (EUCAST) and Clinical and Laboratory Standards Institute (CLSI).</p> <p><strong>Results:</strong> In addition to this, efforts were made to briefly review the evidence available on various formulations of accepted treatment methods including Amphotericin B (AmB), Posaconazole (PSZ), and Isavuconazole (ISZ), and other newer anti-fungal agents such as Voriconazole (VCZ), Echinocandins, etc.&nbsp;&nbsp;</p> <p><strong>Conclusions:</strong> An attempt was also made to discuss the various drugs that can be used as a single agent or combinations considered to be synergistically active and beneficial for the treatment/ prophylaxis of Mucormycosis.</p> Shiva Murthy Nanjundappa Copyright (c) 2021 Shiva Murthy Nanjundappa https://creativecommons.org/licenses/by-nc-nd/4.0 2021-12-01 2021-12-01 2 4 14 21 10.53411/jpadr.2021.2.4.4 ADR Monitoring in a tertiary care centre in Jorhat. https://jpadr.com/index.php/jpadr/article/view/47 <p><strong>Introduction:</strong> Adverse Drug Reactions (ADR) are encountered daily in a hospital setting. They have a significant impact on patients' quality of life. Knowledge of the common ADRs and severity preventability could go a long way in improving the prevailing health scenario.&nbsp; The aim of our study was first, to review types of ADRs related to drugs used in a tertiary care hospital in Jorhat, Assam, India. Second, to analyze the ADRs for causality, severity, and preventability.</p> <p><strong>Methods: </strong>The study was carried out in a tertiary care hospital in Jorhat for six months from 1-June-2016 to 30-Nov-2016. The study population included patients reporting the adverse drug event during the study period in hospital OPD or IPD. Suspected ADRs were reviewed for casualty, severity, and preventability.</p> <p><strong>Results:</strong> Forty-two patients were detected with 9 types of ADRs; with incidence higher in males (61.9 %) than females (38.1 %). The most frequently reported ADRs were tremors (33.3 %), followed by a rash, dizziness, facial and pedal edema. Most of the ADRs were assessed as possible (85.7 %), severity was moderate (61.9 %), and non-preventable (80.9 %) in the majority of the cases.</p> <p><strong>Conclusions:</strong> Significant (p &lt; 0.05) difference was present between the use of multiple drugs and history of previous allergies in between the severity categories of ADRs. The result of our study indicates that the patient taking such drugs should be closely monitored. A database built upon the basis of such studies conducted across multiple centers can go a long way in avoiding clinically significant harmful consequences where the benefits will outweigh the harm.</p> Bijoy Bakal Copyright (c) 2021 Bijoy Bakal https://creativecommons.org/licenses/by-nc-nd/4.0 2021-12-01 2021-12-01 2 4 22 25 10.53411/jpadr.2021.2.4.5 A Hypersensitivity following antivenom administration: A case report https://jpadr.com/index.php/jpadr/article/view/51 <p><strong>Introduction:</strong> Allergic reactions are the most common reported adverse events, after administration of antivenom. Antivenom is the treatment of snakebite. In many parts of the world where snakebite is prevalent, adverse reactions to snake antivenom are common. Acute reactions are mostly mild. Within an hour of exposure to antivenom, severe anaphylaxis may develop.</p> <p><strong>Case Presentation:</strong> Here, we illustrate a case of an 18-year-old female patient who had snakebite but after receiving antivenom, it was followed by local site swelling, rashes, and itching all over the body. It advanced to cellulitis and the patient recovered after a few days and was discharged after treatment. The prevention of reactions will depend mainly on improving the quality of antivenom.</p> Richa Patel Harsha D. Makwana Shikha Sood Supriya Malhotra Copyright (c) 2021 Dr. Richa Patel, Dr. Harsha Makwana, Dr. Shikha Sood, Dr. Supriya Malhotra https://creativecommons.org/licenses/by-nc-nd/4.0 2021-12-01 2021-12-01 2 4 26 28 10.53411/jpadr.2021.2.4.6 Rare adverse drug reaction associated with COVID-19 vaccine – case report https://jpadr.com/index.php/jpadr/article/view/45 <p><strong>Introduction:</strong> India began to administer COVID-19 vaccines on 16 January 2021. As of 31 July 2021, the number of Covid-19 vaccine doses administered in the country has crossed 46 crores. Many adverse drug reactions were reported ranging from mild to severe and common to uncommon.</p> <p><strong>Case Presentation:</strong> Here we report a case of a 50-year-old woman with erythematous macules, plaques, and multiple bullous lesions after vaccination for COVID-19. Blood investigations, histopathological examination, direct immunofluorescence tests were done and diagnosed as Urticarial Vasculitis. She was treated with steroids, antihistamines, antibiotics, and vitamin supplements. She was discharged after one week with oral drugs. As the patient was treated early with prompt medical management she was recovered without any morbidity.</p> Sailaja Priyadarsini Parlapalli Sekhar Bandar Upendra Kumar Mudaragadda Copyright (c) 2021 Sailaja Priyadarsini Parlapalli, Sekhar Bandar, Upendra Kumar Mudaragadda https://creativecommons.org/licenses/by-nc-nd/4.0 2021-12-01 2021-12-01 2 4 29 31 10.53411/jpadr.2021.2.4.7 Cerebral venous sinus thrombosis associated with thrombocytopenia after the second dose of Chadox1 nCov-19 vaccination https://jpadr.com/index.php/jpadr/article/view/53 <p><strong>Introduction:</strong> Reports of cerebral venous sinus thrombosis (CVST) after vaccination against SARS-CoV-2 have raised safety concerns and an emerging mechanism termed vaccine-induced immune thrombotic thrombocytopenia (VITT) was identified.</p> <p><strong>Objective:</strong> We aimed to estimate the frequency of CVST and other cerebrovascular events after vaccination.</p> <p><strong>Case study:</strong> We describe the case of a young male, who developed severe thrombocytopenia and CVST following the second dose of the covid 19 vaccine. He presented with a headache, with subsequent rapid neurological deterioration. The patient was successfully treated and discharged with the stable condition after 09 days of admission. We attribute this Adverse Event following Immunization (AEFI) of thrombotic condition to the vaccine due to the remarkable temporal relationship.</p> <p><strong>Conclusions:</strong> The proposed mechanism of VITT is the production of rogue antibodies against platelet factor-4 resulting in massive platelet aggregation. Radiologists and physicians should be aware and pay attention to early imaging signs of cerebral venous sinus thrombosis for timely diagnosis and treatment.</p> Sagar Bhimani Harsha Makwana Supriya Malhotra Copyright (c) 2021 Sagar Bhimani, Harsha Makwana, Supriya Malhotra https://creativecommons.org/licenses/by-nc-nd/4.0 2021-12-01 2021-12-01 2 4 32 35 10.53411/jpadr.2021.2.4.8