https://jpadr.com/index.php/jpadr/issue/feed Journal of Pharmacovigilance and Drug Research 2022-12-15T16:53:33+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/112 Innovation beyond Artificial Intelligence and Automation 2022-12-15T16:53:32+00:00 Arunima Sen dr.arunima@gmail.com 2022-12-01T00:00:00+00:00 Copyright (c) 2022 Arunima Sen https://jpadr.com/index.php/jpadr/article/view/104 Challenges in monitoring the safety of herbal medicines-an appraisal 2022-12-15T16:53:33+00:00 Muzafar Din Ahmad Bhat drmuzaffar79@gmail.com Rabia Malik rabiamaliku2@gmail.com <p><strong>Introduction</strong><strong>: </strong>Both the medical profession and the general public have started to place a lot of emphasis on drug safety and pharmacovigilance. The use of herbal remedies and phytonutrients is expanding quickly, with many people resorting to these items for the treatment of a range of health conditions in different national healthcare settings. Traditional herbal therapy is frequently used because it is less expensive; more closely aligns with the patient's beliefs, and fills a demand for more individualized healthcare. This promotes a more transparent public approach to health information. Around 80 % of the world's population depends on herbal remedies as their primary source of healthcare and traditional medicine.</p> <p><strong>Objective</strong><strong>: </strong>This study aimed to investigate significant problems associated with monitoring the safety of herbal medicines and to assist the regulatory bodies in refocusing on the requirement for guaranteeing adequate public health protection and promoting safety.</p> <p><strong>Methods</strong><strong>: </strong>The literature was obtained from online databases including Pub Med, Google Scholar, Web of Science, etc. A library search was also conducted from classical Textbooks, and published Books of herbal medicine. The keywords used for the search were pharmacovigilance, herbal medicine; adverse drug reaction; herb-drug interactions.</p> <p><strong>Results</strong><strong>: </strong>Although numerous herbal medications are utilized and some of them have intriguing potential, very few of them have been evaluated, and their usage is not strictly regulated, so it is difficult to determine their potential adverse effects. This makes it challenging to determine the safest and most efficient therapies and to encourage the responsible use of herbal medicine.</p> <p><strong>Conclusion</strong><strong>: </strong>Pharmacovigilance must be used to conduct an empirical clinical assessment to compensate for the lack of safety assessments of herbal drugs. This is only possible if herbal products are subjected to some sort of regulation so that adverse events can be traced.</p> 2022-12-01T00:00:00+00:00 Copyright (c) 2022 Muzafar Din Ahmad Bhat, Dr Rabia Malik https://jpadr.com/index.php/jpadr/article/view/113 Diethylene Glycol Poisoning – Past to Present 2022-12-15T16:53:32+00:00 Porus Rajpurohit Porusrajpurohit93@gmail.com Ganesh Boddu ganesh.boddu@erislifesciences.com Abhijeet Malvi abhijeet.malvi@erislifesciences.com <p>Probably we all have heard many depressing stories already about deadly cough syrup adulterated with Diethylene Glycol (DEG). DEG is a very infamous and dangerous chemical used for mostly preparing pharmaceutical products and consumer products. DEG makes it an excellent counterfeit for pharmaceutical-grade glycerine or propylene glycol, it has a sweetish taste which makes DEG suitable for pharmaceutical preparations. it had been in news for a long back from The Massengill Incident to the recent Gambia tragic incident. The hallmark of DEG poisoning is Acute Renal Failure (ARF). &nbsp;Over the years, DEG has been loaded into all varieties of medicine such as cough syrup, fever medication, injectable drugs, etc. although the batch of the adulterated medicines was recalled after the alert by the time it was recalled it has already caused damage hence, it's not allowed to use in food and drugs by many Health authorities. WHO had warned on time to Health Authorities regarding DEG Mass poisoning. Despite so many tragic incidents and deaths in multiple countries, there is still a lack of regulation for using DEG for pharmaceutical preparations. The generation of scientific knowledge and strict regulation required worldwide to control mass poisoning so that medicines can benefit humankind greatly instead of harming them.</p> 2022-12-01T00:00:00+00:00 Copyright (c) 2022 Porus Rajpurohit, Ganesh Boddu, Abhijeet Malvi https://jpadr.com/index.php/jpadr/article/view/110 Assessment of Knowledge, Attitude, and Practice on Pharmacovigilance among Unani Stakeholders in India: A Cross-Sectional Study 2022-12-15T16:53:32+00:00 Mohd Aleemuddin Quamri drmaquamri@gmail.com Rabia Malik rabiamaliku2@gmail.com Abdul Wadud drwadud87@gmail.com Radhika Kunnavil radhik121@gmail.com <p><strong>Aim</strong><strong>:</strong>&nbsp;To assess the knowledge, attitude, and practice of Pharmacovigilance among Unani stakeholders in India.</p> <p><strong>Methods</strong><strong>:</strong>&nbsp;A cross-sectional, non-interventional, questionnaire-based study was conducted among the Unani stakeholders in India. Data was collected online through a Google form-based self-reported questionnaire.</p> <p><strong>Results</strong><strong>:</strong>&nbsp;The present study revealed that the average knowledge score of the study participants was 11.36± 3.5(Total score 19). Of the total responders, 47% had a low or very low level of knowledge and 53% had a good or high level of knowledge. There was a positive correlation between KAP scores. Knowledge scores were positively correlated with attitude (r=0.258, p&lt;.001) and practice (r=0.056, p=0.067). Attitude scores were also positively correlated with practice scores (r=0.269, p&lt;.001). These findings suggest that knowledge, attitude, and practice scores showed a weak positive correlation.</p> <p><strong>Conclusion</strong><strong>:</strong>&nbsp;This study suggests that the study participants are well-versed in the knowledge of pharmacovigilance, and also have a favorable attitude toward reporting ADRs and misleading advertisements. To implement more effectively the objectives of the pharmacovigilance program of ASU &amp; H Drugs further efforts should be made to increase the practice of pharmacovigilance through awareness programs and on-hand training.</p> 2022-12-01T00:00:00+00:00 Copyright (c) 2022 Mohd Aleemuddin Quamri , Rabia Malik, Abdul Wadud, Radhika K https://jpadr.com/index.php/jpadr/article/view/107 Survey on adverse drug reactions in cancer patients and approaches for its management 2022-12-15T16:53:32+00:00 Sagarika Majhi sagarika.majhi@gmail.com Iti Chauhan iti.pharma@gmail.com Madhu Verma vermadhu1@gmail.com Gauri Goyal gaurigoyal_bpharm18_22@its.edu.in Kartik Bansal kartikbansal_bpharm18_22@its.edu.in <p><strong>Introduction</strong><strong>: </strong>Globally, Adverse drug reaction (ADR) reporting continues to be a challenge. It is estimated that about 95% of AEs never get reported after pharmacotherapy necessitating strategies to improve it. The introduction of databases such as VigiAccess in which ADR data from Pharmacovigilance centers around the world can be assessed is an important step toward improving ADR reporting. This study assessed the therapeutic management of cancer patients in the Delhi-NCR region along with the reporting pattern of ADRs in VigiAccess, an open-access pharmacovigilance database.</p> <p><strong>Methods:</strong>&nbsp;Primarily, the cancer patients were investigated employing a questionnaire. Further, VigiAccess was thoroughly searched for the categories of reported ADRs and the number and types of ADRs reported for a few selected drugs used in the treatment of cancer patients.</p> <p><strong>Results:</strong>&nbsp;After a thorough search through VigiAccess, 06 main categories of reported ADRs in the database were retrieved. These included blood and lymphatic system disorders, skin and subcutaneous tissue disorders, gastrointestinal disorders, psychiatric disorders, respiratory, thoracic, and mediastinal disorders, general disorders, and administration site conditions.</p> <p><strong>Conclusion: </strong>There is a need for vigilant ADR monitoring to decrease morbidity and mortality due to ADRs, which requires further studies on a larger population. This study demonstrated that monitoring of anticancer drugs given in chemotherapy-related ADRs is feasible in a cancer ward and can facilitate quality improvement initiatives, as well as potentially improve patient care.</p> 2022-12-01T00:00:00+00:00 Copyright (c) 2022 Sagarika Majhi, Iti Chauhan, Madhu Verma, Gauri Goyal, Kartik Bansal https://jpadr.com/index.php/jpadr/article/view/105 Drug-drug interactions presenting as Bradyarrhythmia and Hyperkalaemia: A Case Report 2022-12-15T16:53:32+00:00 Hirva S. Santoki drhirvasantoki@gmail.com Sapna D. Gupta sapna_gupta76@yahoo.com Shikha V. Sood shikhavsood@gmail.com Supriya D. Malhotra supriyadmalhotra@gmail.com <p><strong>Introduction: </strong>Drug-drug interactions can be the major negative consequence while using a multidrug treatment approach. Hypertension is one of the preventable causes of cardiovascular disease. Treatment of hypertension is individualized based on the patient’s condition. Some patients may require simultaneous treatment with 4 to 5 anti-hypertensive drugs.</p> <p><strong>Case Details:</strong>&nbsp;We are presenting a case of a 69-year-old female patient, receiving 4 classes of antihypertensive drugs. Patient was admitted in our hospital with hyperkalemia and bradyarrhythmia. The patient had a history of being treated with Atenolol, Losartan, Hydrochlorothiazide, Diltiazem. Hyperkalaemia observed in this patient can be attributed to Losartan and Atenolol. Bradyarrhythmia can be the result of drug interaction between Diltiazem and Atenolol.</p> <p><strong>Conclusion:</strong>&nbsp;Physician should always keep in mind the interactions and adverse effects caused by medications used in treatment of Hypertension.</p> 2022-12-01T00:00:00+00:00 Copyright (c) 2022 Hirva Santoki, Sapna Gupta, Shikha Sood, Supriya Malhotra https://jpadr.com/index.php/jpadr/article/view/111 Anaphylactic reaction to ferric carboxymaltose: A case series 2022-12-15T16:53:32+00:00 Parth Kanani drparthkanani15@gmail.com Sushma Shah arihantostho@gmail.com Supriya Malhotra supriyadmalhotra@gmail.com <p><strong>Introduction: </strong>Intravenous iron is widely used for the treatment of iron deficiency anemia when oral iron is inappropriate, ineffective, or poorly tolerated. Acute hypersensitivity reactions during iron infusions are very rare but can be life-threatening.&nbsp;</p> <p><strong>Case Reports:</strong>&nbsp;We report herein two cases, the first being a case of severe anaphylactic reaction amounting to anaphylactic shock and the second case presenting with an anaphylactic reaction, both with IV Ferric carboxymaltose(FCM) in pregnant women suffering from Iron Deficiency Anemia(IDA).</p> <p><strong>Conclusion: </strong>A public health initiative aimed at reducing the number of severe adverse reactions to parenteral iron would require a rational use of this drug.</p> 2022-12-01T00:00:00+00:00 Copyright (c) 2022 Parth Kanani, Sushma Shah, Supriya Malhotra