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> en-US editor@jpadr.com (Journal of Pharmacovigilance and Drug Research) editor@jpadr.com (Journal of Pharmacovigilance and Drug Research) Tue, 01 Mar 2022 00:00:00 +0000 OJS 3.1.2.1 http://blogs.law.harvard.edu/tech/rss 60 Effects of COVID-19 pandemic on conduct of clinical trials. http://jpadr.com/index.php/jpadr/article/view/67 Medha Joshi Copyright (c) 2022 Medha Joshi https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/67 Tue, 01 Mar 2022 00:00:00 +0000 A review of pharmacovigilance http://jpadr.com/index.php/jpadr/article/view/54 <p><strong>Introduction:</strong> Pharmacovigilance involves more than spontaneous reporting, and is more than just evaluating marketed medications. It has grown from a minor component of drug control to a major activity and expanded its scope to encompass the assistance for patient safety during clinical trials by ensuring adequate informed consent and institutional review boards (ethical committees); development of a safety profile for proper use of a new molecular entity and appropriate communication of that information to a range of relevant stakeholders; selection of the first safe dose for use in humans based on pharmacologic data obtained in animal studies; development of a safety profile. This study implicates the growth of pharmacovigilance in assessing the safety of drugs.</p> <p><strong>Methods:</strong> The subsequent information was obtained by reviewing the data from earlier published material. The obtained information was evaluated, compiled, deconstructed, reassembled, interpreted, and conclusions were reached.</p> <p><strong>Results:</strong> The supply of data necessary for assessing the advantages and dangers of medicines is, first and foremost, a scientific task. Good pharmacovigilance practice must be created to guarantee that data is gathered and used correctly for the intended purpose.</p> <p><strong>Conclusion:</strong> Pharmacovigilance has grown into an essential part of drug control. Signal management protocols ensure that surveillance operations monitor the produced product through collaborative actions with manufacturing specialists, analyze benefit-risk management and inspection readiness maintenance as a corporate culture process.</p> Garima Dhingra, Sonia Tanwar, Devender Sharma, Shweta Parihar Copyright (c) 2022 Garima Dhingra, Sonia Tanwar, Devender Sharma, Shweta Parihar https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/54 Tue, 01 Mar 2022 00:00:00 +0000 Adverse drug reactions reported during pregnancy and associated congenital disorders http://jpadr.com/index.php/jpadr/article/view/58 <p><strong>Introduction:</strong> The main aim of this review is to bring forth the information about adverse drug events that take place because of the consumption of various sorts of medications during pregnancy and also to create awareness regarding birth defects. Not only the recognition of the unfavorable results of the drugs is difficult, but avoiding some of the medications, even during pregnancy, becomes out of the question. The non-inclusion of pregnant females in clinical trials is another factor adding to this problem. It was only after the thalidomide incidence when pharmacovigilance in pregnancy drew focus. Till today, many drugs have been reported to have severe outcomes on the developing fetus which have also had a great impact on their lives.</p> <p><strong>Methods:</strong> Several literary works from various platforms like Google Scholar, PubMed, The Lancet, American Journal of Perinatology, and many others concerning the adverse drug reactions during pregnancy and related fetal disadvantages were thoroughly reviewed.</p> <p><strong>Results:</strong> This review can cater us with a brief idea of the unpleasant results of antidepressants, antibacterials, antihypertensives, NSAIDs, and antithyroid drugs taken during the phase of pregnant nine months. Vaccines, on the other hand, are comparatively safe to use on preggers and are reported with no adverse results. Corona virus was also reported to cause serious illness in pregnant females. However, there were no reports of its vertical transmission. Drug exposure during pregnancy is not completely risk-free and can result in cardiac and CNS malformations, neural tube defects, and many other serious disorders.</p> <p><strong>Discussion:</strong> Numerous unpleasant reactions of the drugs on pregnant females and newborns have been unveiled. Nevertheless, many more such studies are obligatory for bringing forth new knowledge of the unfavorable outcomes of various drugs.</p> Manvi Suri, Jyoti Upadhyay Copyright (c) 2022 Manvi Suri, Jyoti Upadhyay https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/58 Tue, 01 Mar 2022 00:00:00 +0000 Incidence and risk factors for oxaliplatin-induced vascular pain during administration in Iraqi patients http://jpadr.com/index.php/jpadr/article/view/66 <p><strong>Introduction:</strong> The primary objective of this study was to identify the percentage of oxaliplatin-induced vascular pain during administration in Iraqi patients. The secondary objective was to identify the risk factors for vascular pain.</p> <p><strong>Methods:</strong> This is a cross-sectional observational study carried out at the Al-Andalus private hospital for cancer patients, Baghdad, Iraq. The study included 101 patients, diagnosed with one of the following cancers: colon, pancreatic, stomach, and rectal cancer, ranging from 18 to 80 years, and receiving oxaliplatin peripheral venous infusion.&nbsp; Data collected included: age, gender, diagnosis, history of chronic disease, treatment protocol, degree of pain severity, cancer stage, history of previous vascular pain, number of cycles, the incidence of vascular pain, oxaliplatin dose.</p> <p><strong>Results:</strong> Sixty-two patients out of 101 patients had experienced vascular pain during oxaliplatin peripheral venous infusion, representing about (61.4 %). History of diabetes mellitus was significantly associated with vascular pain induction (OR=1.59, [CI: 1.07 - 2.39]). The age group from 40-60 years old was significantly associated with 59 % higher odds of vascular pain (OR=1.59, CI: 1.07 - 2.39) than other age groups. Female patients were significantly associated with 59 % higher odds of vascular pain (OR=1.59, CI: 1.07 - 2.39) than males.</p> <p><strong>Conclusion:</strong> The results of this study indicate that history of diabetes mellitus, the age group from 40-60 years old, and female gender are risk factors for oxaliplatin-induced vascular pain in patients with GI malignancy. These findings could be useful to assess the risk of vascular pain in clinical settings.</p> Yaala Saady Raof Al-Bairmany, Noor Kasib Hadi, Mays Alrubayi Copyright (c) 2022 Yaala Saady Raof Al-Bairmany, Noor Kasib Hadi, Mays Alrubayi https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/66 Tue, 01 Mar 2022 00:00:00 +0000 The Knowledge, attitude, and practice among Ayurvedic scholars and trainees towards pharmacovigilance: a questionnaire-based survey in Gujarat, India http://jpadr.com/index.php/jpadr/article/view/60 <p><strong>Aim:</strong> The study was carried out to assess the knowledge, attitude, and practice of scholars and trainees studying in Ayurveda colleges of Gujarat state regarding pharmacovigilance and ADR reporting.</p> <p><strong>Methods: </strong>The questionnaire-based study was carried out during December 2020 and January 2021. Total 29 questions covering points like participants' knowledge, attitude, and practice towards pharmacovigilance, adverse drug reaction reporting, and misleading advertisements related to Ayurveda drugs were made available to participants in Google forms through their Emails. The result was presented using simple frequencies with percentages in appropriate tables.</p> <p><strong>Results:</strong> A total of 1790 scholars and trainees from 17 different colleges of Gujarat state participated in the survey. The majority of participants were BAMS students (97. 15 %) and from private colleges (81. 79%). Analysis of survey data reveals that the majority of the respondents have better knowledge and attitude, but limited practice regarding pharmacovigilance and ADR reporting. &nbsp;Among the respondents, 86. 74 % had correctly defined the Pharmacovigilance and 69. 32 % knew about the specific ADR reporting form for ASU&amp;H drugs. Even though ADR reporting was considered to be important by a large majority of the participants (87. 95 %), the actual practices of ADR reporting were very low. A large number of respondents were also not familiar with reporting misleading advertisements.</p> <p><strong>Conclusion:</strong> Findings of the present study reflect a good knowledge of the participants about the concept of Pharmacovigilance but lack of skill in practicing the same. The positive attitude towards the practice of Pharmacovigilance and ADR reporting may help in improving ADR monitoring and reporting. &nbsp;Further, it can be suggested that integration of this subject in the curriculum is pivotal in improving the ongoing pharmacovigilance activities.</p> Rabinarayan Acharya, Raghavendra Naik, Sourav Rang , Chitrangad A. Jani , Galib R, Sudipt Rath Copyright (c) 2022 Rabinarayan Acharya, Raghavendra Naik, Sourav Rang , Chitrangad A. Jani , Galib, Sudipt Rath https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/60 Tue, 01 Mar 2022 00:00:00 +0000 A rare case report of linezolid induced thrombocytopenia http://jpadr.com/index.php/jpadr/article/view/64 <p><strong>Introduction:</strong> Oxazolidinone like linezolid are widely used antibiotics because of the growing prevalence of resistant gram-positive infections. Because of its unique mode of action by inhibiting protein synthesis, it is widely effective against various resistant strains like penicillin-resistant and vancomycin-resistant strains of various gram-positive bacteria. It is widely used in the treatment of skin and soft tissue infection including MRSA and MSSA, also used in community-acquired pneumonia, and the combination is used in extensively drug-resistant tuberculosis. The most common side effect of linezolid includes gastrointestinal disturbances like nausea and vomiting. Serious adverse effects include Myelosuppression including thrombocytopenia, anemia, pancytopenia, and leukopenia. Peripheral neuropathy, optic neuritis, and lactic acidosis are also reported.</p> <p><strong>Case Presentation</strong>: Here we report a case of progressive but reversible thrombocytopenia in 75 years old male patient after receiving linezolid therapy for severe sepsis with multi-organ dysfunction with AKI on CKD with hepatic encephalopathy, severe hyponatremia with aspiration pneumonia. On the 9<sup>th</sup> day of linezolid, therapy thrombocytopenia was noted and immediately linezolid was stopped. After the 12<sup>th</sup> day, his platelet count went up which might be suggestive of linezolid induced thrombocytopenia.</p> <p><strong>Conclusion:</strong> Physicians should be more vigilant in monitoring complete blood count, especially in elderly patients who are receiving linezolid for more than two weeks. They should also make a risk assessment based on creatinine clearance, baseline platelet count, immunosuppression therapy, baseline hemoglobin, and prior/present antibiotics therapy so that adverse reactions can be prevented.</p> Ashish Karn, Mausam Jain, Bhavya Modi, Riki Patel Copyright (c) 2022 Ashish Karn, Mausam Jain, Bhavya Modi, Riki Patel https://creativecommons.org/licenses/by-nc-nd/4.0 http://jpadr.com/index.php/jpadr/article/view/64 Tue, 01 Mar 2022 00:00:00 +0000