https://jpadr.com/index.php/jpadr/issue/feed Journal of Pharmacovigilance and Drug Research 2022-09-03T06:54:55+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>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> https://jpadr.com/index.php/jpadr/article/view/101 Risk Communication in Pharmacovigilance: Lookouts, Challenges and Strategies 2022-09-03T06:54:55+00:00 Sakshi desai sakshi.pihu@gmail.com <p style="text-align: justify;"><span lang="EN-US">Risk communication is a critical aspect of pharmacovigilance that must be considered by organizations during their Risk Management planning phase. The main challenges that hinder effective risk communication is its dependence on the perception of stakeholders, underpinned by their opinions, experiences and emotional responses to risk.&nbsp; The way to address these challenges is two-fold. One is dealing with it at a strategic level which involves collaborative problem-solving providing an understanding of strengths and limitations of risk analysis along with tools for internal and external communication to ensure consistent messaging. And the second is dealing at an interpersonal level, which involves utilizing empathetic listening to understand needs of the stakeholders and then sharing expert insights, translating technical information into understandable language to ensure effective delivery of messages. Ultimately, integrating expert communication with computational methods creates a strong foundation and increases success of risk communication.</span></p> 2022-09-01T00:00:00+00:00 Copyright (c) 2022 Sakshi desai https://jpadr.com/index.php/jpadr/article/view/102 Role of Automation, Natural Language Processing, Artificial Intelligence, and Machine Learning in hospital settings to identify and prevent Adverse Drug Reactions 2022-09-03T06:54:55+00:00 Akanksha Togra akankshatogra97@gmail.com Sudhir Pawar akankshatogra97@gmail.com <p style="text-align: justify;"><span lang="EN-IN">Patient Safety is at the center of all pharmacovigilance activities. As several covariates can impact the safety of a medicinal product in patients, a large amount of data is required for an accurate assessment of the safety and therefore, the benefit-risk balance of a medicinal product. Natural language processing, Artificial Intelligence, and Machine Learning are being popularly used to facilitate various pharmacovigilance activities in the Pharma industry. Artificial Intelligence and Machine learning if properly used in hospital settings can also facilitate the identification of adverse events from hospital records and discharge summaries and prescription errors, thus, alerting treating physicians regarding the same. However, the potential of using these techniques needs to be fully explored in hospital settings to facilitate the collection and evaluation of safety data.</span></p> 2022-09-01T00:00:00+00:00 Copyright (c) 2022 Akanksha Togra, Sudhir Pawar https://jpadr.com/index.php/jpadr/article/view/81 Need for involving the pharmaceutical industry in the national pharmacovigilance program of Nepal 2022-09-03T06:54:55+00:00 Nisha Jha nishajha32@gmail.com Yunima Sapkota yunima.sapkota@gmail.com Pathiyil Ravi Shankar ravi.dr.shankar@gmail.com <p style="text-align: justify;"><strong>Introduction:</strong> Adverse drug reactions (ADRs) have high morbidity and mortality and can cause a significant burden on patients. Most of the data on ADRs are generated from the developed world, and these data cannot be generalized to developing nations due to the variation in prescribing patterns, regulatory policies, and varied effects of drugs. Implementing a successful pharmacovigilance program in many developing countries faces several challenges including under-reporting, human resource shortage, financial challenges as well as poor policy and legal framework.</p> <p style="text-align: justify;"><strong>Method:</strong> In this commentary, we aim to explore the situation of Pharmacovigilance in Nepal through a close comparison with India and suggest ways to strengthen the same.</p> <p style="text-align: justify;"><strong>Results:</strong> Nepal is still in the beginning stage of Pharmacovigilance and ADR reporting is quite low. The Pharmacovigilance System in Nepal is limited to regional centers which report ADRs to the national center. There is no involvement of pharmaceutical industries in the system which may be a major reason for underreporting and suboptimal functioning of the pharmacovigilance system.</p> <p style="text-align: justify;"><strong>Discussion: </strong>Nepal must mandatorily involve pharmaceutical industries in pharmacovigilance. The new drug policy is under revision and addresses aspects of pharmacovigilance in terms of patient safety and the role of pharmaceutical companies.</p> 2022-09-01T00:00:00+00:00 Copyright (c) 2022 Nisha Jha, Yunima Sapkota, Pathiyil Ravi Shankar https://jpadr.com/index.php/jpadr/article/view/80 Role of monteleukast in the treatment of covid – 19 an overview 2022-09-03T06:54:55+00:00 Thurka S thurka.s10@gmail.com Sravani Marpaka sravani.marpak21@gmail.com Chakradhar T tchakradhar21@gmail.com Swati Negi negiswati591@gmail.com <p style="text-align: justify;"><strong>Introduction:</strong> COVID – 19 infections that has shaken the world by leading into a significant health issue. World is in the need for effective therapies in order to improve clinical outcomes of patients. We must consider new approaches in the treatment of COVID-19. In order to bring effectiveness in treatment, it is important to know the exact pathogenesis of the virus so that it will pave a path for an efficient treatment.</p> <p style="text-align: justify;"><strong>Methods:</strong> To ensure comprehensive research and discuss the objective of the review of the study, literature collection was collected from the relevant published articles from databases such as “PubMed, Medline, and SCOPUS,”</p> <p style="text-align: justify;"><strong>Results:</strong> COVID-19 is linked with severe inflammation. Pro-inflammatory cytokine levels are elevated in the lung and in bronchial cells. Leukotrienes [LTs] are eicosanoids and inflammatory mediators. Leukotrienes are produced by various cell types which includes, leukocytes. Cysteinyl-leukotrienes (CysLTs) are involved in respiratory pathologies such as inflammation, thrombosis and vascular damage, and fibrotic remodeling.</p> <p style="text-align: justify;"><strong>Discussion:</strong> Hence there is a rational for LTs inhibition and montelukast usage in respiratory diseases beyond asthma. Various literatures suggest the use of LT receptor antagonist ‘Montelukast’ in COVID – 19 treatments.</p> <p style="text-align: justify;"><strong>Conclusion:</strong> This review article will discuss various aspects of Montelukast in COVID – 19 treatments and reviews the properties of montelukast that could be beneficial in the treatment of COVID-19.</p> 2022-09-01T00:00:00+00:00 Copyright (c) 2022 Thurka S, Sravani Marpaka, Chakradhar T, Swati Negi https://jpadr.com/index.php/jpadr/article/view/98 Determination of In vitro lethality of actinomycetes antibiotic extracts from Menengai crater geothermal vents, Kenya 2022-09-03T06:54:55+00:00 Paul Njenga Waithaka waithakanj@gmail.com <p style="text-align: justify;"><strong>Introduction:</strong> Drug resistance is the biggest threat to human existence today. This study was conducted to investigate the sensitivity of selected pathogenic microorganisms to antibiotic extracts from soils of Menengai crater geothermal vents in Kenya.</p> <p style="text-align: justify;"><strong>Method:</strong> Antibiotic-producing actinomycetes were isolated from geothermal vents of the crater. The isolates were identified using colony characteristics and biochemical means. Sensitivity of the selected pathogenic microorganism was carried out using primary and secondary screening techniques. Four actinomycetes coded PAN 9, PAN 18, PAN 117, and PAN 138 were selected for further analysis based on the size of the zone of inhibition and the broad spectrum of activity. Extraction of antibiotics from the selected actinomycetes was carried out using ethyl acetate. A sensitivity test of the pathogens to the extracts was done using Karby Bauer disk diffusion technique. Cytotoxicity of the antibiotic extracts was carried out using Brine shrimp lethality test and sheep blood hemolytic bioassays. The isolates presented typical actinomycetes characteristics.</p> <p style="text-align: justify;"><strong>Results:</strong> A total of 20 actinomycete isolates showed antagonism against the test pathogenic microorganisms. The selected actinomycetes inhibited growth of Gram-positive and negative bacterial and fungal pathogens in both primary and secondary sensitivity tests. There was a significant difference in the diameters of zones of inhibition produced by the test pathogens when subjected to the antibiotic metabolites from the selected actinomycetes (F = 6.6046 P = 0.001338).</p> <p style="text-align: justify;"><strong>Discussion:</strong> The minimum inhibitory concentration and minimum bactericidal concentration/minimum fungicidal concentration did not vary significantly (F=0.4503, P = 0.7187). The LC<sub>50</sub> values of the antibiotic extracts varied from 2.438±0.47µg in PAN 9 to 9.3455±0.41µg in PAN 138. PAN 18 and PAN 117 showed partial hemolysis while PAN 9 and PAN 138 exhibited complete hemolysis of sheep blood erythrocytes. Soils from Menengai crater geothermal vents have actinomycetes that produce antibiotics. The antibiotics are cytotoxic to brine shrimps. In addition, the antibiotics cause hemolysis of sheep blood erythrocytes. There is a need to purify the antibiotics and structure elucidate them.&nbsp; The active antibiotic extract needs to be evaluated to determine whether the hemolysis is due to the compound itself or some other chemical constituent.</p> 2022-09-01T00:00:00+00:00 Copyright (c) 2022 Paul Njenga Waithaka https://jpadr.com/index.php/jpadr/article/view/97 The efficacy of single dose palonosetron in highly emetogenic chemotherapy protocols compared to oral aprepitant and ondansetron 2022-09-03T06:54:55+00:00 Yaala Saady Raof Al-Bairmany Dr.yaalasaady@hotmail.com Noor Kasib Hadi Noorkasib7@gmail.com Abdul Karim Nazar abdalkareem96@gmail.com <p style="text-align: justify;"><strong>Background:</strong> Chemotherapy-induced nausea and vomiting (CINV) is a common problem during cancer treatment and its proper management is essential. The primary objective of this study was to compare the efficacy of a single dose palonosetron in the control of chemotherapy-induced nausea and vomiting (CINV) to that of oral aprepitant and ondansetron.&nbsp; The secondary objective is to determine age, gender, morning sickness, motion sickness, as well as chemotherapy protocols as risk factors in increasing chemotherapy-induced nausea and vomiting (CINV).</p> <p style="text-align: justify;"><strong>Methods: </strong>This is a prospective cohort study carried out at Al-Andalus Private Hospital for Cancer Patients in Baghdad, Iraq. The study included 296 patients, diagnosed with cancer, and receiving high emetogenic chemotherapy protocol. Patients were divided into 3 arms according to the antiemetic received. Arm 1 received aprepitant and ondansetron, arm 2 received ondansetron, and arm 3 received palonosetron. The primary endpoint was the response rate defined as the percentage of patients without nausea or vomiting episodes during the chemotherapy treatment cycles. Other secondary endpoints such as age, gender, morning sickness, motion sickness, as well as chemotherapy protocols, were measured as risk factors in increasing chemotherapy-induced nausea and vomiting (CINV).</p> <p style="text-align: justify;"><strong>Results:</strong> A total of 296 patients, diagnosed with cancer, and receiving high emetogenic chemotherapy protocol were evaluated. There was no significant association between age or gender and CINV. The incidence of nausea and vomiting with ondansetron was more than the incidence of nausea and vomiting with aprepitant, and the incidence of nausea and vomiting with palonosetron was less than the incidence of nausea and vomiting with aprepitant. There was no significant association between morning sickness and nausea or vomiting. On the other hand, there was a significant association between motion sickness and nausea or vomiting. The most common cycle reported in nausea and vomiting was cycle 3. Regarding suffering from nausea and vomiting with some chemotherapy drugs, the most common drugs were adriamycin cyclophosphamide (AC) and carboplatin.</p> <p style="text-align: justify;"><strong>Conclusion:</strong> The results of the present study confirm the previous reports on the superiority of palonosetron over ondansetron and its aprepitant in reducing the incidence of CINV. Regarding risk factors, motion sickness, chemotherapy cycle 3, as well as adriamycin cyclophosphamide (AC) and carboplatin were risk factors inducing CINV in high emetogenic chemotherapy protocols.</p> 2022-09-01T00:00:00+00:00 Copyright (c) 2022 Yaala Saady Raof Al-Bairmany , Noor Kasib Hadi , Abdul Karim Nazar https://jpadr.com/index.php/jpadr/article/view/99 Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals 2022-09-03T06:54:55+00:00 Sony Chandi Shrestha soneem@gmail.com Kebreab Ghebremeskel k.ghebremeskel@londonmet.ac.uk Kenneth White kenneth.white@londonmet.ac.uk Caterina Minelli caterina.minelli@npl.co.uk Ihab Tewfik I.Tewfik@westminster.ac.uk Panna Thapa pannathapa@ku.edu.np Sundus Tewfik drsundustewfik@gmail.com <p style="text-align: justify;"><strong>Introduction:</strong> Although Nepal joined the WHO program for International Drug Monitoring in 2006, published data about Nepalese health professionals’ understanding of pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) is limited.</p> <p style="text-align: justify;"><strong>Objectives<em>:</em></strong>&nbsp;The purposes of this study were to: (1) investigate awareness, knowledge, attitude, and practice (KAP) of pharmacovigilance among health professionals and (2) gain insight into the ADRs reported for statins in Nepal.</p> <p style="text-align: justify;"><strong>Methods:</strong>&nbsp;125 health professionals (doctors, pharmacists/assistant pharmacists, and nurses) were recruited from health care institutions (hospitals, clinics, pharmacies) in Kathmandu, Nepal. Electronic and paper survey data were collected with the use of a validated questionnaire between April and December 2018. The multiple-choice questionnaire was structured to assess the KAP of pharmacovigilance, and ADRs associated with statins, and consisted of two open-ended questions for health professionals to give suggestions for the improvement of the pharmacovigilance system. Statistical Package for the Social Sciences (SPSS, version 25) was used to analyze the demographic and pharmacovigilance data. The main outcome measures were KAP of pharmacovigilance and ADRs reported for statins.</p> <p style="text-align: justify;"><strong>Results:</strong>100 (80%) participants (44 doctors, 32 pharmacists / assistant pharmacists, 24 nurses) completed the self-administered questionnaire. Pharmacovigilance knowledge, attitude, and practice scores were 71%, 81%, and 53%, respectively. There was a significant difference between the number of knowledgeable health professionals (71 vs. 29%, p &lt; 0.05) and had a favorable attitude (81 vs. 19%, p &lt; 0.05) toward pharmacovigilance and ADR reporting compared with those who did not. The number of participants who did not report ADR was higher than those who did (90 vs. 10%, p &lt; 0.05). The adverse reactions associated with statins were muscle symptoms (62%), elevated activity of liver enzymes (24%), and gastrointestinal symptoms (9%).</p> <p style="text-align: justify;"><strong>Conclusion:&nbsp;</strong>Despite the knowledge and willingness of health professionals to report ADRs, the practice of pharmacovigilance remains low in Nepal. There is a need for clear and enforceable regulations for monitoring and reporting ADRs, and effective educational interventions to promote pharmacovigilance practices.</p> 2022-09-01T00:00:00+00:00 Copyright (c) 2022 Sony Chandi Shrestha, Kebreab Ghebremeskel, Kenneth White, Caterina Minelli, Ihab Tewfik, Panna Thapa, Sundus Tewfik https://jpadr.com/index.php/jpadr/article/view/87 Life threatening gastrointestinal tract complications in a patient of rheumatoid arthritis. Is it drug or disease related? 2022-09-03T06:54:55+00:00 Kanisha Shah drkanisha25@gmail.com Sapna D. Gupta sapna_gupta76@yahoo.com Supriya D. Malhotra supriyadmalhotra@gmail.com <p style="text-align: justify;"><strong>Introduction:</strong> Gastrointestinal (GI) complications are very frequent and sometimes fatal in patients with Rheumatoid Arthritis (RA). Gastrointestinal perforation is a rare but serious event, most frequently involving the lower GIT, which has been observed in patients with RA.</p> <p style="text-align: justify;"><strong>Case Presentation:</strong>&nbsp;We present here an Adverse Drug Reaction (ADR) which is small bowel ischemia with perforation in a 61-year-old RA patient, who was taking a tablet of Prednisolone and tablet Hydroxychloroquine.</p> <p style="text-align: justify;"><strong>Discussion:</strong> Several studies indicated that RA patients may be at a higher risk of GI perforation. This could be attributed to the disease pathophysiology or the use of drugs for treatment like Glucocorticoids and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Rheumatologists must be vigilant for GI complications while prescribing anti-rheumatoid drugs.</p> <p style="text-align: justify;"><strong>Conclusion:</strong>&nbsp;GI perforations are rare events in RA patients, but cause significant morbidity and mortality. Increasing age and other comorbid conditions also increase the risk of adverse GI events.</p> 2022-09-01T00:00:00+00:00 Copyright (c) 2022 Kanisha Shah, Sapna D. Gupta, Supriya D. Malhotra