Journal of Pharmacovigilance and Drug Research http://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> <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>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> en-US editor@jpadr.com (Journal of Pharmacovigilance and Drug Research) editor@jpadr.com (Journal of Pharmacovigilance and Drug Research) Wed, 01 Mar 2023 08:35:07 +0000 OJS 3.1.2.1 http://blogs.law.harvard.edu/tech/rss 60 Peptic ulcer in nephrotic syndrome patients due to steroid therapy http://jpadr.com/index.php/jpadr/article/view/120 <p style="text-align: justify;">Peptic ulcers comprise gastric and duodenal ulcers. Complications of peptic ulcers include bleeding, perforation, and obstruction. Bleeding is a major problem of peptic ulcers, as it is at times fatal. Peptic ulcer bleeding is diagnosed and treated by upper gastrointestinal (GI) endoscopy. Oral glucocorticosteroids (referred to hereafter as corticosteroids) are commonly prescribed for symptom control in patients receiving palliative care. A recent study has shown that one-third of patients admitted to an inpatient hospice unit were receiving corticosteroids. This frequency in prescribing exposes a large number of patients to the potential side effects known to be associated with corticosteroids, including weight gain, impaired glucose tolerance, and proximal myopathy.H. pylori infection is a risk factor for PUD in aspirin and NSAID users.</p> Sreeja Ankireddypalli Copyright (c) 2023 Sreeja Ankireddypalli https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/120 Wed, 01 Mar 2023 00:00:00 +0000 Evaluation of short-term COVID-19 vaccines adverse events following immunization severity as reported by Iraqi consumers http://jpadr.com/index.php/jpadr/article/view/114 <p style="text-align: justify;"><strong>Introduction:</strong> Consumer-generated Adverse Events Following Immunization (AEFI) reports are a major source of vaccine safety information in pharmacovigilance, which was unprecedented within the Iraqi settings.</p> <p style="text-align: justify;"><strong>Methods:</strong> A self-assessment form was developed to be accessed by the consumers country-wide via the Iraqi pharmacovigilance center’s (IPvC) WhatsApp number. A retrospective analysis was then performed on the responses submitted from April 2021 until April 2022. Different independent variables were analyzed for their influence on subjective AEFI severity.</p> <p style="text-align: justify;"><strong>Results:</strong> 2843 responses were finally included. The average number of reported AEFI was 4.03 (S.D. ± 2.58) per response and significantly different among vaccine types. Both Comirnaty and Vaxzevria-associated AEFIs were reported to affect daily life similarly (~59 %), while Sinopharm was 42.4 %. Treatment-seeking was highest in Vaxzervria reports (22.8 %). Factors associated with higher reported severity include; younger people, females, and previous COVID-19 infection. Also, for the Comirnaty vaccine, the second dose. Fever, body rash, and difficulty breathing were the most significantly associated with treatment-seeking. A very small number of serious AEFIs were also detected.</p> <p style="text-align: justify;"><strong>Conclusion:</strong> Consumer reporting is valuable for generating data regarding COVID-19 vaccines’ AEFIs within the Iraqi spontaneous surveillance system and their engagement is recommended in the future for other medicinal products as well.</p> Ban Al-Shimran, Manal Younus, Balqees Salih Copyright (c) 2023 Ban Al-Shimran, Manal Younus, Balqees Salih https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/114 Wed, 01 Mar 2023 00:00:00 +0000 A cross-sectional survey to assess the efficacy of home remedies during Covid times from a Pharmacovigilance perspective http://jpadr.com/index.php/jpadr/article/view/88 <p style="text-align: justify;"><strong>Introduction:</strong> Many strategies have been suggested for the prevention of COVID-19 such as the intake of certain home remedies.</p> <p style="text-align: justify;"><strong>Objectives</strong>: To assess the efficacy of home remedies like <em>Kadha </em>(Decoction) consumed during covid times and document the adverse events if any due to indiscriminate use of home remedies.</p> <p style="text-align: justify;">To document various home remedies used by the public to boost immunity.</p> <p style="text-align: justify;"><strong>Method</strong>: About 130 patients who attended the OPD at Central Ayurveda Research Institute (CARI), Bengaluru were included in the survey by using a questionnaire. The questionnaire was prepared to collect information regarding the intake, type, duration, and benefits of home remedies.</p> <p style="text-align: justify;"><strong>Results</strong>: It was observed that a majority of the participants in the study were not aware of the long-term consequences of consuming a particular home remedy. Due to the fear of covid and faith in home remedies, many opted for a preventive measure. Ginger was the most frequently used drug as a home remedy and hyperacidity with heartburn was the most common untoward effect observed due to the inappropriate use of the home remedies.</p> <p style="text-align: justify;"><strong>Conclusion</strong>: Ayurveda emphasizes diet and regimen as a part of the treatment along with <em>Aushadha Sevana Kaala </em>(the time of administration of medicine). When home remedies are consumed without medical supervision and without adhering to the basic principles as cautioned in Ayurvedic medicine, it is bound to cause some untoward effects. This study is a humble attempt in this direction.</p> Shubhashree MN, Raghavenda Naik, Chandini Chandrasekharan, Sulochana Bhat Copyright (c) 2023 Shubhashree MN, Raghavenda Naik, Chandini Chandrasekharan, Sulochana Bhat https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/88 Wed, 01 Mar 2023 00:00:00 +0000 A factor of anti-atherosclerotic activity-fibrinolytic activity of venom of Buthus tumulus species (Indian red scorpion) http://jpadr.com/index.php/jpadr/article/view/117 <p style="text-align: justify;"><strong>Introduction:</strong> Atherosclerosis (AS) is an inflammatory disease of the arterial blood vessels (arteries), in which the walls of the blood vessels become thickened and hardened specifically due to atheromatous plaques. The plaques are composed of cholesterol and other lipids, inflammatory cells, and calcium deposits. There are five different types of atherosclerosis such as in the aorta, coronary, cerebral, renal, and pulmonary arteries. The scorpion species that present medical importance belonging to the family Buthidae Scorpion toxins consist of several peptides isolated from the venom of different species of scorpion and are based on their pharmacological action and also agree well with the structural properties of this peptide family.</p> <p style="text-align: justify;"><strong>Method:</strong> The study was conducted in the Department of Pharmacology, Modern College of Pharmacy, Nigadi, Pune in the year June 2012- June-2013 by In-vitro blood clot dissolving activity of SV and artificial blood clot degradation method</p> <p style="text-align: justify;"><strong>Results:</strong> It was observed that SV was evaluated for its fibrinolytic properties in the In-vitro blood clot dissolving method and shown to decrease the stained area of the blood-stained cloth as compared to the control.</p> <p style="text-align: justify;"><strong>Conclusion:</strong> In the artificial blood clot degradation method, the color intensity is higher in the test tube containing SV compared to the control and hence, it can be stated that SV has fibrinolytic activity.</p> Renuka Bhoi, Sonali Nipte, Mamata Pandey Copyright (c) 2023 Renuka Bhoi https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/117 Wed, 01 Mar 2023 00:00:00 +0000 Oxytocin induced itching in a 37 week primigravida with meconium stained liquor http://jpadr.com/index.php/jpadr/article/view/116 <p style="text-align: justify;"><strong>Introduction:</strong> Oxytocin is the most frequently used medication for labour augmentation in obstetrics. One of the known benefits of its use is the improvement of uterine contractions. An injectable form of oxytocin is administered intravenously as an infusion.&nbsp; Adverse drug reactions at this stage may distress the baby and worsen the outcome of the pregnancy.</p> <p style="text-align: justify;"><strong>Case details:</strong> A 19-year-old female with a history of nine months gestation presented in labour.&nbsp; She was administered oxytocin infusion in ringer lactate to augment labor. She developed itching all over her body and was immediately administered Inj. hydrocortisone intravenously. As the foetus was in distress, she was taken for an emergency lower segment cesarean section (LSCS).</p> <p style="text-align: justify;"><strong>Conclusion:</strong> The administration of IV oxytocin was considered the possible cause of the development of rashes in this case. We suggest adopting preventive strategies to avoid ADRs in emergencies to avoid deleterious consequences. The preventive strategies may include screening in the antenatal period for previous history of sensitivity to oxytocin, latex, etc. In addition, other strategies are discussed in this article.</p> Disha Sai M Chandavar, Shiva Murthy Nanjundappa, Dr. Priyanka Reddy, Dr. Nagendra Prasad N Copyright (c) 2023 Dr Shiva Murthy Nanjundappa, Disha Sai M Chandavar, Dr. Nagendra Prasad N, Dr. Priyanka Reddy https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/116 Wed, 01 Mar 2023 00:00:00 +0000 Rifampicin-Amlodipine Interaction: A Case Report of Hypertension Exacerbation http://jpadr.com/index.php/jpadr/article/view/121 <p style="text-align: justify;"><strong>Introduction: </strong>Rifampicin, a first-line anti-tubercular therapy drug, is a strong inducer of hepatic cytochrome P450 (CYP). Amlodipine and metoprolol, two anti-hypertensives that are CYP substrates, have the potential to interact pharmacologically with rifampicin. Therefore, individuals with hypertension receiving rifampicin-based anti-tubercular therapy are at risk for worsening hypertension.</p> <p style="text-align: justify;"><strong>Case Details:</strong> We report a case of a 63-year-old female patient, who developed accelerated hypertension after initiating rifampicin. Later, up to four antihypertensive drugs were administered as part of a gradual increase in dosage but did not successfully lower blood pressure to a desirable level. After clinical pharmacist intervention, Tab. Amlodipine+Metoprolol 5 mg+50 mg was discontinued and the blood pressure measurements gradually improved.</p> <p style="text-align: justify;"><strong>Conclusion:</strong> We postulate that rifampicin diminished the therapeutic effect of amlodipine and metoprolol and hence recommend that prudent monitoring for worsening hypertension should be carried out in hypertensive patients with chronic kidney disease receiving anti-tubercular therapy. </p> Sinchana Bojamma P.K, Narne Akhil Copyright (c) 2023 Sinchana Bojamma P.K, Narne Akhil https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/121 Wed, 01 Mar 2023 00:00:00 +0000 AICTE Sponsored National Conference http://jpadr.com/index.php/jpadr/article/view/122 <p>Sovenier (ETRAPS- 2023)</p> Pratap Kumar Patra Copyright (c) 2023 Pratap Kumar Patra https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/122 Wed, 01 Mar 2023 00:00:00 +0000