http://jpadr.com/index.php/jpadr/issue/feed Journal of Pharmacovigilance and Drug Research 2024-02-20T08:48:20+00:00 Journal of Pharmacovigilance and Drug Research editor@jpadr.com Open Journal Systems <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> <p><strong>Aims and Scope</strong></p> <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>Authors can submit manuscripts related to&nbsp;</p> <p>1. Pharmacovigilance</p> <p>2. Materiovigilance/Technovigilance</p> <p>3. Ecopharmacovigilance</p> <p>4. Ayurvedic drugs safety</p> <p>5. Pharmacology</p> <p>6. Computer-aided drug design</p> <p>7. Formulation of pharmaceutical research and development</p> <p>8. Animal Study</p> <p>9. Preclinical trials</p> <p>10. Clinical trials</p> <p>11. Biotechnology</p> <p>12. Pharmacoepidemiology</p> <p>13. Ergonomics</p> <p>14. Newly identified drug</p> <p>15. Haemovigilance</p> <p>16. Artificial Intelligence and Machine Learning in Pharmaceutical Drug Development</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> <p><strong>Ethical code</strong></p> <p>Before submitting an article for possible publication in the journal, we recommend that you read our <a href="https://jpadr.com/index.php/jpadr/Publication-Ethics" target="_blank" rel="noopener">code of ethics for authors</a><strong>.</strong></p> <p><strong>Article Processing Charge (APC)</strong></p> <p>Publication in the JPADR is subject to APC, more information can be found <a href="https://jpadr.com/index.php/jpadr/APC-and-Waiver-Policy" target="_blank" rel="noopener">here</a><strong>.</strong></p> <p><strong>Publication frequency</strong></p> <p>The journal has a quarterly frequency. Four issues are published a year that cover the periods January-March, April-June, July-September, and October-December.</p> <p><strong>Open access statement</strong></p> <p>The JPADR is loyal to open access, allowing any users to read, download, copy, distribute, print, search, or link to the full texts of its articles and to use them for any other lawful purpose. All the articles published in the journal have immediate free access from their publication date. We do not charge any fees for reading or downloading articles.</p> <p><strong>Archiving</strong></p> <p>The published contents in the journal are archived in the <a href="https://jpadr.com/index.php/jpadr/gateway/clockss" target="_blank" rel="noopener">CLOCKSS</a> and <a href="https://jpadr.com/index.php/jpadr/gateway/lockss" target="_blank" rel="noopener">LOCKSS</a> systems.</p> <p><strong>License and copyright </strong></p> <p>Articles in the JPADR are published under the <a href="https://creativecommons.org/licenses/by-nc-nd/4.0/" target="_blank" rel="noopener">CC BY-NC-ND 4.0</a> License. This allows authors the reproduction of articles, free of charge, for non-commercial use only, and with the appropriate citation information. All authors publishing in the JPADR retain copyright over their work.</p> <p><strong>Society information</strong></p> <p>The <a href="https://globalpvs.com/" target="_blank" rel="noopener">Global Pharmacovigilance Society</a> is composed of a team of pharmacovigilance professionals and leaders across the world aimed to protect patients from any serious adverse event following the administration of any drug. The objective of this society is to improve patient and drug safety. We discuss the strategies to strengthen the pharmacovigilance system. We tend to organize webinars, conferences, and camps to create awareness among the public for adverse drug reactions (ADR) reporting.</p> <p>&nbsp;</p> <p>&nbsp;</p> http://jpadr.com/index.php/jpadr/article/view/153 Pharmacovigilance in Nepal: Present Glance and Areas to Improve. 2024-02-20T08:48:02+00:00 Roshan Giri phr.roshan4542@gmail.com Aman Kumar Sah aman.bch2021@gmail.com Uday Bir Shahi udaybirshahi@gmail.com <p>As the global issues ponder upon the drug safety and Consumer pharmacovigilance<strong>, </strong>pharmacovigilance in Nepal started from year 2004, however is still at infancy stage. In this commentary we aimed to portray the past and present state of the PV in Nepal along with some of the international and resource limited countries situation along with the areas we can work upon for the effective adverse event reporting, assessment, monitoring and management which leads to the drug safety and quality medicine use in some context in the resource limited countries like Nepal.</p> 2023-12-01T00:00:00+00:00 Copyright (c) 2023 Roshan Giri, Aman Kumar Sah, Uday Bir Shahi http://jpadr.com/index.php/jpadr/article/view/150 Analysis of drug-induced pancreatitis reports within the United States Food and Drug Administration and Veterans Health Administration Drug Event Reporting Systems 2024-02-20T08:48:20+00:00 Kristen Wilhite kristen.wilhite@va.gov Jennifer Meyer Reid Kristen.wihite@va.gov Carrie Isaacs Kristen.wihite@va.gov Matthew Lane Kristen.wihite@va.gov <p><strong>Introduction:</strong>&nbsp;A true case of drug-induced pancreatitis (DIP) can be difficult to define due to a lack of monitoring parameters and potential confounders to the diagnosis of pancreatitis. Adverse drug event (ADE) reporting systems may give insight into which medications and drug classes are most commonly associated with DIP.</p> <p><strong>Objectives:</strong>&nbsp;This study aimed to analyze two United States (US) ADE reporting systems to determine the most common drugs associated with a report of DIP and to compare what is reported to what is published about drugs that carry a high risk of DIP. &nbsp;</p> <p><strong>Methods:</strong>&nbsp;We conducted a retrospective, cross-sectional evaluation of ADE reports from the Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) between 2007 – 2021. &nbsp;&nbsp;</p> <p><strong>Results:</strong>&nbsp;We identified 53,181 and 1,520 reports of suspected DIP from the FDA and VHA databases, respectively. Incretin-based therapies (GLP-1 RAs and DPP-4is) were the most common drugs with DIP reports in both databases. &nbsp;</p> <p><strong>Conclusions:</strong>&nbsp;Incretin-based therapies comprised approximately 1 in every 5 reports of suspected DIP submitted to two major US ADE databases from 2007 - 2021. &nbsp;These newer medication classes appear to be associated with pancreatitis more frequently than traditional culprit medications.</p> 2023-12-01T00:00:00+00:00 Copyright (c) 2023 Kristen Wilhite, Jennifer Meyer Reid, Carrie Isaacs, Matthew Lane http://jpadr.com/index.php/jpadr/article/view/152 Knowledge, attitude, and practices regarding reporting of Adverse Events Following Immunization (AEFI) among healthcare professionals 2024-02-20T08:48:12+00:00 Girish Hiremath drgirishkpl@gmail.com Jyothi R joe6gowda@gmail.com Akash Gadgade drakashgadgade@gmail.com Nikita Sudhir Kulgod nikitakulgod@gmail.com Ashwini M Kambalyal ashwinikambalyal00@gmail.com Bhoomi Chirag Bagadia bhoomibagadia0909@gmail.com Jhilli Basu drjhillibasu@gmail.com Udaya K magnetronmedics@gmail.com <p><strong>Background</strong><strong>:</strong>&nbsp;Vaccines enhance immunity, yet Adverse Events Following Immunization (AEFI) challenge public trust and immunization coverage by impacting safety perceptions.</p> <p><strong>Materials and Methods</strong><strong>:</strong>&nbsp;In Karnataka, India, this cross-sectional study employed self-administered questionnaires at sub-centers (SC) and primary health centers (PHC). Findings were tabulated and analyzed using chi-square (p&lt;0.05).</p> <p><strong>Results</strong><strong>:</strong>&nbsp;From 247 subjects, the study achieved a 95% response rate. Notably, 65% exhibited proficient AEFI knowledge, and 88% possessed a favorable attitude toward reporting practices. Age, gender, prior training, and service duration were significant factors for knowledge distinctions. Attitude variations correlated with age, AEFI knowledge, and previous training. Identified barriers impact knowledge, attitude, and reporting.</p> <p><strong>Conclusion</strong><strong>:</strong>&nbsp;The majority of healthcare workers at PHC and SC had good knowledge and positive attitudes with good reporting practices of AEFI. A few factors that hinder the diagnosis and reporting must be addressed by routine in-service training. The use of e-media should be brought into practice.</p> 2023-12-01T00:00:00+00:00 Copyright (c) 2023 Girish Hiremath, Jyothi R, Akash Gadgade, Nikita Sudhir Kulgod, Ashwini M Kambalyal, Bhoomi Chirag Bagadia, Jhilli Basu, Udaya K http://jpadr.com/index.php/jpadr/article/view/155 Knowledge and practice of Iraqi community pharmacists on national adverse events reporting and review of the constraints of drug safety reporting 2024-02-20T08:47:54+00:00 Samer Shukur Mohammed samer.shukur@ruc.edu.iq Wael Waleed Musatafa Wael.waleed@turath.edu.iq Manal Mohammed Younus manalyounus@gmail.com <p><strong>Introduction</strong><strong>: </strong>Pharmacovigilance aids in protecting patients from adverse drug effects. Community pharmacists can play a significant role in the reporting of adverse drug reactions (ADRs) due to their advantageous position in terms of direct contact with patients and medical specialization,</p> <p><strong>Objectives: </strong>To determine the pharmacists' awareness in Baghdad and attitude regarding the national adverse drug reactions (ADRs) system activities in Iraq and their knowledge about the spontaneous reporting system</p> <p><strong>Methods: </strong>In this study, a validated self-administered cross-sectional questionnaire was used. During the study period, the questionnaire was distributed to 278 community pharmacists who worked in Baghdad for 4 months.</p> <p><strong>Results: </strong>Out of 278 pharmacists who participated in this questionnaire, 250 pharmacists completed the questionnaire. About 57% of them were female with less than 10 years experience in retail pharmacies. The study showed that about 76% already had information about the term pharmacovigilance and the existence of a pharmacovigilance center in Iraq, but about half of them showed a low level of knowledge about the way of filling, reporting, and sending &nbsp;ADR reports. Furthermore, About 90% of them prefer new ways of filling the ADR reports like using special mobile apps, special QR codes, and more simplified adverse event forms.</p> <p><strong>Conclusion: </strong>The study revealed that the community pharmacists in Baghdad have a positive view on ADR and pharmacovigilance, but several barriers were revealed that could impede the Iraqi pharmacovigilance center activities regarding spontaneous reporting of health care professionals.</p> 2023-12-01T00:00:00+00:00 Copyright (c) 2023 Samer Shukur Mohammed, Wael Waleed Musatafa, Manal Mohammed Younus http://jpadr.com/index.php/jpadr/article/view/157 Methotrexate overdose induced acute kidney injury and pancytopenia: a case report 2024-02-20T08:47:46+00:00 Gunjan Gayen gunjan.gayen93@gmail.com Tapas Bera drtapasbera@gmail.com Abhik Saha pharma.abhik91@gmail.com Ramtanu Bandyopadhyay drrbanerjee18@gmail.com Sagnik Chakraborty amisagnik003@gmail.com <p><strong>Introduction</strong><strong>:</strong>&nbsp;Methotrexate is a folic acid antagonist. Dose of methotrexate is ranging from 7.5 mg–30 mg per week. In rheumatoid arthritis (RA), a low dose of methotrexate is used.</p> <p><strong>Case presentation</strong><strong>:</strong>&nbsp;A 48-year-old female patient suffering from RA, was admitted to a tertiary care hospital. The patient was taking&nbsp;methotrexate 15 mg daily instead of once weekly dosing schedule mistakenly (cumulative dose of 105 mg). The patient presented with a diffuse ecchymotic rash over both extremities with oral mucositis associated with dysphagia. Upon investigation, pancytopenia (TLC= 3400 /µL, RBC= 1.85 Lac/µL, Platelets= 6000/µL) with microcytic hypochromic anemia (Hb= 4.3 g/dl) with acute kidney injury (Urea= 78 mg/dl, Creatinine= 2.26 mg/dl)&nbsp;was found. Elevated C-reactive protein (9.8 mg/dl) and dyslipidemia (Triglyceride= 218 mg/dl) were also evident.&nbsp;The case was suspected to be methotrexate toxicity and reported in the suspected Adverse Drug Reaction (ADR) form(v1.4).</p> <p><strong>Management</strong><strong>:</strong>&nbsp;The patient was advised to stop methotrexate and manage with injectable folinic acid (25 mg thrice Daily for 3 days) and clotrimazole mouth paint locally (thrice daily for two weeks). ADR was assessed as Probable/Likely&nbsp;(WHO-UMC scale),&nbsp;Probable (Naranjo scale), Severe (Modified Hartwig's Severity scale), and Preventable (Schumock and Thronton scale).</p> <p><strong>Conclusion</strong><strong>:</strong>&nbsp;Such case report being the first line of evidence for recognizing unexperienced ADR, should be reported for 'signal detection' &nbsp;to improve patient care and safety.&nbsp;Prescription Audit Guidelines (under National Health Mission) should be followed for drug dispensing.</p> 2023-12-01T00:00:00+00:00 Copyright (c) 2023 Gunjan Gayen, Tapas Bera, Abhik Saha, Ramtanu Bandyopadhyay, Sagnik Chakraborty