Journal of Pharmacovigilance and Drug Safety 2020-08-18T10:50:40+00:00 Prof. (Dr.) Farhan Ahmad Khan Open Journal Systems <p style="text-align: justify;">In the modern era of clinical application of knowledge of pharmacology, it is a big dilemma in hoosing between the good and the best drug. In making a decision for treatment planning clinician must consider the additional features of local and systemic issues, patient's economic status as well as potential adverse effect of the drug.</p> <p style="text-align: justify;">There are large number of drug trial going on world wide to observe the effect of a particular drug or a molecule. However, the scenario has changed drastically in last 20 years. What it was with the western/ developed world is now shifting over to developing world.</p> <p style="text-align: justify;">India is set to grab clinical trial business, making the subcontinent world's preferred destination for clinical trials. The big reason being low cost of trial along with friendly drug control system with&nbsp;competent work force and patient availability. Indian investigators and clinical trial research professionals have already demonstrated their medical and scientific skills in various global clinical trials. It is time now to capitalize on this opportunity. Indian investigators and research professionals can prove their ability and show to the world and register their presence now as well as for future.</p> <p>&nbsp;</p> A Critical Assessment of Rationality in Drug promotion literature using WHO Guidelines 2020-08-04T07:01:03+00:00 Mohd Ashraf Alam Mohammad Nasiruddin Gufran Ali <div class="page" title="Page 1"> <div class="section"> <div class="layoutArea"> <div class="column"> <p>Background Aim: To evaluate the scientific and ethical status of the drug promotional literature available in the Indian market for accuracy, consistency, and validity of information present in it using WHO criteria.<br>Methods: A cross‐sectional, observational study was carried out in the department of pharmacology for evaluation of 180 drug promotional literature by WHO‐criteria, collected randomly from outpatient departments of JN. Medical College and Hospital, Aligarh, a tertiary care hospital in Northern India. They were also analyzed for different claims, catchy terms, quality of paper and print, and representation of data with statistics/diagram/table and references cited in support of their claims for their source, year of publication, authenticity, and retrievability.</p> <p>Results: 45% of literature were designed for promotion of fixed dose‐drug combinations (FDCs), and 55% were single-dose formulations. Most of the drug promotional literature collected were from CVS, Endocrinology, GIT &amp; Chemotherapy. Most of them mentioned indication, dosage form, and its strength and description of the product and package. Description of pharmacological effects and mechanism of action was present only in 31% of literature. More than (90%) were lacking information related to indications, correct dosage regimen, and dose adjustments in special situations, as well as the dosage in Paediatrics and elderly. False/tall claims, catchy/broken statements were given in 81% and 58% of literature, respectively. Irrelevant diagrams were depicted in 69%. References were cited in 69% of literature, of which 92% were from indexed‐journals and were retrievable. Conclusion: Critical assessment of drug promotional literature can make drug prescribing more effective. In our study, the majority of DPLs satisfied only half of the WHO criteria, and none of them fulfilled all the specified DPL criteria. Incomplete or embellished information in DPLs may mislead physicians and might lead to an irrational prescribing. Therefore, physicians must critically evaluate DPLs regarding updated scientific evidence required for quality patient care.</p> </div> </div> </div> </div> <p>&nbsp;</p> 2020-06-30T00:00:00+00:00 Copyright (c) 2020 Mohd Ashraf Alam, Mohammad Nasiruddin, Gufran Ali Safety study of Baobarang (Embelia ribes Burm. f.) 2020-08-04T07:01:04+00:00 Moin uddin . Nazish Siddiqui Sumbul Rehman <p><strong><em>Background: </em></strong><em>Herbal Unani drugs represent an important class of traditional medicine system. According to WHO nearly 70-80% of world population relies on traditional medicines. Herbs are used for the treatment and prevention of various ailments. With increasing interest in herbal products there is an increasing concern over the herbal drugs safety. People assume that they are natural so they are safe but there are incidences of toxicity and adverse effects. Safety study of herbal drugs and food items is now mandatory as per WHO guidelines, to prevent the toxicity due to the material found in the soil and the environment. </em></p> <p><strong><em>Methods: </em></strong><em>Plants are vulnerable to be contaminated with harmful ingredients. It includes determination of Microbial load, Heavy metals by AAS, Aflatoxins LC-MS/MS and Pesticide Residues using GC-MS/MS. Therefore, the present study aimed to evaluate safety parameters in Baobarang (EmbeliaribesBurm. f.) belonging to the family Myrsinaceae.</em></p> <p><strong><em>Results:</em></strong> <em>Safety study revealed the presence of heavy metals, lead, cadmium, mercury and arsenic within permissible limit as per WHO guide line while aflatoxin, pesticides&nbsp; and microbial load were found to be absent in the crude drug sample.</em></p> <p><strong><em>Conclusion: </em></strong><em>From the safety profile obtained it can be concluded that&nbsp; the test drug is safe for use and free from chances of toxicity</em></p> <p>&nbsp;</p> 2020-06-30T00:00:00+00:00 Copyright (c) 2020 Moin uddin ., Nazish Siddiqui, Sumbul Rehman Safety of Medicinal Tropical Natural Products – Concerns and Issues 2020-08-04T07:01:05+00:00 Syed Ziaur Rehman Sulthan Al Rashid <p><strong><em>Background: </em></strong><em>No medicinal product is safe whether it is of streamline medicine or belongs to traditional system of medicine. Tropical products of natural drugs, fruits and supplements, no matter how common it’s clinical uses, have the potential to cause harm. It is true that adverse reactions are a cost of modern medical therapy, but indigenous drugs used in traditional medicines especially herbs and tropical products are also not safe in true sense. In addition, in recent years, there have been several other high-profile herbal safety concerns that have had an impact on the public health, and there is increasing recognition of the need to develop Pharmacovigilance systems for medicinal herbs and tropical products.</em></p> <p><strong><em>Methods: </em></strong><em>Pharmacovigilance should be a priority for every country with a public health disease. The focused Pharmacovigilance initiatives for the safe treatment of tropical diseases such as malaria, leishmaniasis and schistosomiasis, involving the administration of medicines to large communities are being implemented within the same population with little knowledge of, or regard to, how these various medicines could interact with each other. Moreover, Pharmacovigilance approach to tropical herbal products including natural substances and supplements and monitoring the safety of herbal medicines presents unique challenges. </em></p> <p><em>&nbsp;</em><strong><em>Results:</em></strong> <em>This paper aims to provide a critical overview of the current state of Pharmacovigilance activities for some tropical diseases and herbal tropical medicines at the national and global levels. It will explore in depth the challenges that Pharmacovigilance of herbal medicines presents, consider relevant emerging issues and what steps could be taken to improve the safety monitoring for herbal medicines in the future.</em></p> <p><strong><em>Conclusion: </em></strong><em>Pharmacovigilance practices for herbal medicine are different from that of conventional drugs. The existing systems developed for synthetic medicines and</em></p> <p><em>require some modifications to address specific differences of herbal medicines including medicinal products of tropical natural drugs, fruits and supplements. It also needs to be implemented to find and remove secondary toxic metabolites in tropical foods.</em></p> <p>&nbsp;</p> 2020-06-30T00:00:00+00:00 Copyright (c) 2020 Syed Ziaur Rehman, Sulthan Al Rashid Who is pushing patients to death trap by improper use of codeine? Time now to reorient physicians or ban the use of codeine! 2020-08-18T10:50:40+00:00 KC Singhal KC Garg Syed Ziaur Rahman <p><em>A single case report of an elderly female patient was discussed in this present paper. The patient was admitted to a metropolitan tertiary care hospital as a case of analgesic nephropathy and ankylosing spondylitis. She was advised codeine and other groups of medicines, but her condition got worsened day by day and eventually expired. The case was found irrationally treated and led to alleged iatrogenic death and hence discussed here in terms of the patient’s age, comorbidities, concomitant medicines, and dose calculation.</em></p> <p>&nbsp;</p> 2020-06-30T00:00:00+00:00 Copyright (c) 2020 KC Singhal, KC Garg, Syed Ziaur Rahman