Journal of Pharmacovigilance and Drug Research 2021-11-28T07:11:57+00:00 Journal of Pharmacovigilance and Drug Research Open Journal Systems <p class="has-text-align-justify has-text-color" style="text-align: justify;">Journal of Pharmacovigilance and Drug Research (JPADR) provides a platform for pharmacovigilance professionals to share their research experience with all the researchers, scientists, physicians, scientists across the globe regarding adverse events associated with a particular drug.</p> <p class="has-text-align-justify has-text-color" style="text-align: justify;">JPADR is a quarterly journal with 4 issues per year. The received manuscripts from all the researchers undergo a peer-review process prior to their publications. As per the quality standard of our articles, we accept a manuscript with less than 20 % similarity passing through plagiarism software.</p> <p class="has-text-align-justify has-text-color" style="text-align: justify;">We accept manuscripts that could be review work, short notes, original research, case studies. It could be accepted from academic institutions, hospitals, and pharmaceutical industries. The pharmacovigilance professionals working for other institutions, such as contract research organizations (CROs), clinical research centers, and software companies can also submit their research work to protect the patients from unexpected adverse drug reactions.</p> <p class="has-text-align-justify has-text-color" style="text-align: justify;">Please read carefully the instructions for the author prior to submitting manuscripts for the safety of drugs as well as patients.</p> <p class="has-text-align-justify has-text-color" style="text-align: justify;"><span class="has-inline-color">Filter your manuscripts through software such as Grammarly, citation machine, cite this for me to generate quality manuscripts, prior to submitting it to us. Thank you.</span></p> Vaccine safety surveillance across the globe with a focus on the COVID-19 vaccines 2021-11-28T07:11:57+00:00 Arunima Sen <p style="text-align: justify;">Taking a bird's eye's view across the globe to understand the different methods to look at vaccine safety surveillance, one thing becomes clear. The commitment to monitor the safety of a vaccine does not stop at the clinical development stage. Rather, awareness, reporting, and research need to be bolstered after the vast population gets exposed to the vaccine. Global collaboration, understanding, and embracing the global best practices will go a long way to ensure safer vaccinations. With the COVID-19 pandemic already creating havoc in minds of all, the panic or unacceptance about the vaccination side effects in the population is undesirable.&nbsp; Adverse events are the unfortunate yet unavoidable element in the journey of a new drug or a vaccine. But since it is a healthy population who are recipients of vaccines, the researchers and PV professionals need to be more mindful of the risk-benefit profile of the vaccine.</p> 2021-09-01T00:00:00+00:00 Copyright (c) 2021 Arunima Sen One size does not fit all: a summary of signal detection methods 2021-10-07T10:00:06+00:00 Rajrajeshwari R Patil Vivek Singh <p style="text-align: justify;"><span lang="EN-IN">The selection of an appropriate signal detection method is pivotal in the identification process of safety signals in pharmacovigilance. Nevertheless, the early detection of safety signals is even more important to prevent the occurrence of another thalidomide tragedy in humans. Spontaneous reports, follow-up studies, scientific literature, preclinical &amp; clinical studies, are valuable sources of adverse events; but on the other hand, these reported adverse events are extremely diverse, hence comprehending this can result in formulating the right signal detection and evaluation strategies. Broadly, signal detection methods fall into two categories: qualitative and quantitative, each having its significance; while the quantitative methods help to handle the voluminous data during signal detection, the qualitative one does its part to pick the rare signals. Hence, there is no single universal method that would be a perfect fit to identify safety signals from all data sources or for all types of adverse events. Further, the signal detection process involves a series of steps right from signal detection to its final assessment &amp; submission, to regulatory authorities confirming a signal as a 'possible safety alert'. Finally, the completed task of finding a confirmed safety alert would be meaningless if it does not reach the end-users of the drug concerned. Therefore, effective communication to health care professionals, patients including clinical trial subjects, pharmaceutical companies, and other stakeholders is equally important.</span></p> 2021-09-01T00:00:00+00:00 Copyright (c) 2021 Rajrajeshwari R. Patil, Vivek Singh Safety of Hydroxychloroquine use for COVID-19 prophylaxis: A questionnaire-based pilot study in healthcare professionals 2021-09-03T17:10:34+00:00 Pratibha Nadig Vamsavardhan Reddy Anupam Bhambhani Ravikiran Satyagama Suvarchala Supriya Acharya <p style="text-align: justify;"><span lang="EN-IN">Hydroxychloroquine (HCQ) was recommended for prophylaxis against SARS-COV-2 for the health care professionals by the Indian Council for Medical Research. We conducted this study to explore the safety of Hydroxychloroquine in health care professionals. A validated questionnaire was circulated electronically to the health care professionals, who were on HCQ as per ICMR recommended regimen. Questions on specific adverse drug reactions (ADRs) were asked along with other details. The participants were requested to upload the baseline and additional electrocardiograms (ECGs) taken during HCQ prophylaxis. Incidence, severity, causality (relatedness to the drug), expectedness, and seriousness of the ADRs were determined as per the standard guidelines. The ECGs were evaluated for the appearance of significant changes. The observations were analyzed through descriptive statistics. The ECG changes were compared using the Students t-test and the association of risk factors with the ADRs was evaluated using logistic regression analysis. ADRs were observed in 58 (46 %) of 126 participants. Gastrointestinal symptoms followed by headache and skin rashes were commonly observed. The ADRs were mostly mild to moderate in the category, non-serious, and possibly related to HCQ. Significant ECG changes were rare. Diabetes, hypertension, and the use of concomitant medication/s were the risk factors. Except for blurred vision, all the ADRs were unexpected in terms of frequency. HCQ causes non-specific ADRs of mild to moderate degrees when used as prophylaxis. Though non-serious, almost all were unexpected. ECG changes are probably not frequent in the absence of a pre-existing disease.</span></p> 2021-09-01T00:00:00+00:00 Copyright (c) 2021 Pratibha Nadig, Vamsavardhan Reddy, Anupam Bhambhani, Ravikiran, Satyagama Suvarchala, Supriya Acharya Pharmacovigilance- A drug safety monitoring tool 2021-09-03T18:45:00+00:00 Shivangi Chauhan <p style="text-align: justify;"><span lang="EN-US">The objective of this narrative review is to converse about drug safety, global pharmacological authorities and their responsibility, the process of adverse event reporting, and the main functions of pharmacovigilance. Pharmacovigilance is a science that ensures patient safety against both newly launched and well-established medicinal products in the market. Pharmacovigilance is considered a specific tool used for observing and estimating Adverse Drug Reactions (ADRs) and is essential for successful drug management programs, clinical trials, and public health programs. In the few past years, the number of reported ADRs got increased as a result of which the volume of data got increased. To handle such huge data and the need to understand the pharmacovigilance, it requires highly skilled and proficient people for immediate detection of drug's side effects and protects the product from improper removal. The existing global network of pharmacovigilance centers will be strengthened through an independent review process in coordination with the Uppsala Monitoring Center. Its main role is to assess trials and crucial issues of drug safety that probably influence public health beyond national borders. In this global arena, Pharmacovigilance becomes an important and integral part of clinical research. Most of the countries set up pharmacovigilance centers to monitor drug safety; however, millennial pharmacovigilance faces major challenges for improved safety and drug monitoring.</span></p> 2021-09-01T00:00:00+00:00 Copyright (c) 2021 Shivangi Chauhan A Retrospective observational survey of adverse events following immunization comparing tolerability of covishield and covaxin vaccines in the real world 2021-09-03T17:10:33+00:00 Porus Rajpurohit Manoj Suva Hardik Rajpurohit Yogesh Singh Praveen Boda <p><span lang="EN-IN">The COVID-19 vaccination drive is on a boost in India. On 16-January-2021 India has successfully driven the biggest vaccination drive for 300 million priority groups against the coronavirus disease (COVID-19) and rolled out the world's largest vaccination drive to vaccinate around. People were confused about which vaccination to choose and many were unaware of how these two vaccines differ from one other, while the government was working hard to build confidence and encourage people to come forward to take the made-in-India Covid-19 vaccine (COVAXIN and COVISHIELD). However, the result of the first phase and second phase vaccination drive clearly shows that both the Indian vaccines are effective and safe. Since, both the Indian vaccines have received Emergency Use Authorization&nbsp; (EUA) by Drugs Controller General of India (DCGI) in India, the regulatory agency and the manufacturers are keeping a close watch and monitoring on the Adverse event reported following immunization (AEFI) and to allow quick identification and action of any new safety information. A retrospective observational cohort survey was conducted on 75 fully vaccinated volunteers. The data was collected and analyzed. The percentage of The AEFI experienced with COVISHIELD vs COVAXIN during 1st does was 92.45 % vs 77.27 % and with 2nd dose 86.79 % vs 72.72 % respectively. However, no SAE was reported during the survey and almost 20 % of subjects were aware of the AEFI reporting but because of negligence, didn't report. Fever was the most common AEFI experienced in both vaccines. Only 6.66 % of volunteers got an infection with COVID-19 post-vaccination.</span></p> 2021-09-01T00:00:00+00:00 Copyright (c) 2021 Porus Rajpurohit, Manoj Suva, Hardik Rajpurohit, Yogesh Singh, Praveen Boda Spontaneous cardiac tamponade associated with dabigatran use in an elderly woman 2021-09-03T17:10:34+00:00 Anupam Bhambhani Sahithi Sharma Aditi Nadamani <p style="text-align: justify;"><span lang="EN-NZ">We report here a rare case of dabigatran-related spontaneous cardiac tamponade, which appeared in absence of the known risk factors that predispose the patient to bleed related to anticoagulant drugs. A 65-year-old lady presented to the emergency room with sudden onset dyspnea which woke her up in the early morning hours. Four days earlier, she had been started on dabigatran therapy for DVT. On examination, she was in shock. Transthoracic echocardiography confirmed cardiac tamponade. Emergent pericardiocentesis was done, draining 480 ml of haemorrhagic fluid, which tested negative for microbes and malignant cells. The patient recovered rapidly and fluid did not re-accumulate after withdrawal of dabigatran therapy. Spontaneous cardiac tamponade is rare with the use of direct anticoagulants, especially dabigatran, in the absence of predisposing risk factors. This case study highlights the need for clinicians to be cognizant of this potentially life-threatening adverse drug reaction of dabigatran so that appropriate timely action can be taken toward diagnosis and management of this complication.</span></p> 2021-09-01T00:00:00+00:00 Copyright (c) 2021 Anupam Bhambhani, Sahithi Sharma, Aditi Nadamani Transient liver enzyme derangement following Remdesivir use: a case series 2021-09-03T17:10:34+00:00 HARSH PATEL Harsha Makwana Karan Shah Supriya Malhotra <p style="text-align: justify;"><span lang="EN-US">Remdesivir, a nucleotide analog RNA polymerase inhibitor, which was originally evaluated in clinical trials to thwart the Ebola outbreak in 2014, has shown in vitro efficacy against SARS-CoV-2. Experience on its efficacy and safety in COVID-19 is accumulating. In COVID-19, Remdesivir therapy is given intravenously for 5 to 10 days and is frequently accompanied by transient, reversible mild-to-moderate elevations in serum aminotransferase levels but has been only rarely linked to instances of clinically apparent liver injury as a drug-induced liver injury (DILI). It may be caused by direct toxicity possibly due to inhibition of mitochondrial RNA polymerase. Here, we have discussed two cases where liver enzyme levels increased dramatically on the day next after initiating Remdesivir. Case one and two showed grade 4 and grade 3 hepatotoxicity respectively. In both cases, a positive de-challenge was observed and concomitant drugs were not considered to be confounders.&nbsp; Hence, Remdesivir has a causal relationship with the occurrence of this adverse drug reaction.</span></p> 2021-09-01T00:00:00+00:00 Copyright (c) 2021 Harsh H. Patel, Harsha D. Makwana, Karan B. Shah, Supriya D. Malhotra