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   2021| March-April  | Volume 53 | Issue 2  
    Online since May 26, 2021

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Adverse event reporting tools and regulatory measures in India through outcome of Pharmacovigilance Programme of India
Jai Prakash, Raghav Sachdeva, Tarani Prakash Shrivastava, CV Jayachandran, Aseem Sahu
March-April 2021, 53(2):143-152
DOI:10.4103/ijp.ijp_901_20  PMID:34100398
The primary care medical practitioners as well as common public must be made aware of the importance and benefits of reporting adverse drug reactions (ADRs). The reporting of ADRs through periodic safety update reports is a regulatory requirement in many countries including India, however, the importance of ADR reporting through spontaneous reporting system cannot be ignored. After the initiation of Programme for International Drug Monitoring, WHO-Uppsala Monitoring Centre (UMC), Sweden, succeeded in establishing a worldwide pharmacovigilance (PV) network in >150 countries. As a full member of this program, India also has developed a robust PV system through Pharmacovigilance Programme of India (PvPI) involving its various ADR Monitoring Centers and after due quality check of Individual Case Safety Reports (ICSRs), submits this information to UMC through a web-based tool VigiFlow®. This information is then stored into VigiBase® which is the repository of worldwide ICSRs. Based on the drug safety information collected, PvPI issues alerts, recommends label change (if any), and identifies signals thereby supporting National Regulatory Authority. At national level, PvPI has developed several tools for reporting of ADRs by the stakeholders. This article provides an overview of adverse events reporting tools in India vis-a-vis selected countries around the world, based on a comparative literature search. This article also throws light upon the regulatory aspects of PV in India, findings of PvPI and its recommendations to Central Drugs Standard Control Organization, collaboration of PvPI with Public Health Programmes, future prospects of reporting ADRs in India and how it will help enhance the quality of ADR-reporting by citizens of India.
  7,262 332 4
Prediction of pharmacokinetic values of two various dosages of caffeine in premature neonates with apnea
Fatemeh Faramarzi, Mohammadreza Shiran, Mohammadreza Rafati, Roya Farhadi, Ebrahim Salehifar, Maryam Nakhshab
March-April 2021, 53(2):108-114
DOI:10.4103/ijp.IJP_504_19  PMID:34100394
Objectives: Despite extensive caffeine use in preterm infants, the pharmacokinetics (PKs) data are limited because of the studies are complicated to do in these patients. This research was investigated the PK profile of two various dosages of caffeine in premature neonates. Materials AND METHODS: The PK values of caffeine in premature neonates with Apnea were predicted by using all of computer-based simulation (Simcyp®), population-based PK, and modeling (P-Pharm®). We assayed the plasma levels of caffeine in two groups. The information was analyzed utilizing nonlinear mixed-effects modeling approach. The PK parameters were assessed simulating virtual clinical considers with subjects got 20 mg. kg−1 of caffeine in both groups, which was followed by a 5 mg. kg−1 once daily in Group 1 or 2.5 mg. kg−1 twice daily in Group 2. All statistical analysis was executed utilizing SSPS issue 19 and a P value of 0.05 was chosen significance. Results: In the present study, the means CL, volume of distribution, and T1/2 of caffeine in preterm infants were 0.0476 L. h−1, 1.1081 L, 16.2284 h, respectively. Whereas our simulated means by Simcyp were 0.090 L. h−1, 1.841 L, and 14.653 h in Group 1 and 16.223 h in Group 2, respectively. Conclusions: There was overall good agreement between predicted and measured PK values in our study. This study provides an initial demonstration of Simcyp simulation advantage on anticipating of PK parameters.
  3,966 79 1
Marathon mice: researcher view on potential roles in preclinical research
J Kumaravel, K Sowmini, Pramod Avti, Bikash Medhi
March-April 2021, 53(2):99-102
DOI:10.4103/ijp.ijp_324_21  PMID:34100392
  3,880 134 -
Medication – A boon or bane: Emergencies due to medication-related visits
Mamta Madhiyazhagan, Sudhakar Geratala Dhanapal, Priya Ganesan, Kundavaram Paul Prabhakar Abhilash
March-April 2021, 53(2):103-107
DOI:10.4103/ijp.IJP_357_20  PMID:34100393
Background: Medication-related visits (MRV) to the Emergency Department (ED) are substantial though weakly recognized and intervened. Data from developing countries on the prevalence of MRV-related ED admissions are scanty. This study is first of its kind in India to estimate the prevalence of MRV, its severity and the factors contributing to these visits. Methodology: This prospective observational study was done in the ED of an apex tertiary care center in August 2018. A convenient cross-sectional sample of patients presenting with emergencies regarding drug use or ill-use were included and a questionnaire filled after obtaining a written informed consent. Results: During the study period, a cross-sectional sample of 443 patients was studied and the prevalence of MRV was 27.1% (120/443). The mean age was 55 (standard deviation: 15) years with a male preponderance (60.8%). Triage priority I patients comprised 39.1%. Common presenting complaints included vomiting (25%), seizure (20.8%), giddiness (20%), and abdomen pain (17.5%). Less than ½ (43.3%) were compliant to prescribed medication. The most common reasons for MRV were failure to receive drugs/noncompliance (47.5%), subtherapeutic dosage (25%), and adverse drug reaction (16.7%). Severity of MRV was classified as mild (50%), moderate (38.3%), and severe (11.7%). Out of these visits, 71 (59.2%) were deemed preventable. Three-fourths (73.3%) were stabilized and discharged from the ED. Conclusion: The fact that a quarter of the ED visits are due to MRV and that more than half of them are preventable is quite alarming. Diligent patient education by the treating physicians may perhaps help in decreasing the incidence of this deleterious event.
  3,768 117 -
Development of a psoriatic-like skin inflammation rat model using imiquimod as an inducing agent
Komal M Parmar, Chetan S Jagtap, Nitin T Katare, Mahaveer Dhobi, Satyendra K Prasad
March-April 2021, 53(2):125-131
DOI:10.4103/ijp.IJP_506_19  PMID:34100396
Objective: The present investigation was undertaken to develop a psoriatic-like skin inflammation rat model using imiquimod (IMQ) as an inducing agent. Materials and Methods: The hairs of the back dorsal portion of the Wistar rats were removed and 80, 100, and 120 mg of IMQ cream (5% w/w) for 10 consecutive days was applied to different groups of rats. Further, psoriasis area severity index was used for calculating the psoriatic score, which included scoring of erythema, scaling, and thickening. Various biochemical parameters, pro-inflammatory cytokines, vascular endothelial growth factor (VEGF), and histopathological examination were also performed. Results: The results demonstrated signs of erythema, scaling, and thickening on group applied with 120 mg and 100 mg of IMQ along with ear thickening. Biochemical evaluation revealed a significant increase in the granulation tissue weight followed by significant decrease in the levels of collagen and hexosamine. The antioxidant parameters superoxide dismutase and catalase were found to decline, while nitric oxide and lipid peroxidation were significantly elevated in skin lesions, also supported by increased pro-inflammatory cytokines expression, i.e., interleukin (IL)-1 β, IL-6, IL-17, tumor necrosis factor-α, and VEGF. Histopathological studies revealed a disturbed natural structure along with increased epidermal proliferation, abnormal differentiation with increased number of keratinocytes in the psoriatic skin tissue. Conclusion: From the overall study, we have successfully developed a psoriatic-like skin inflammation rat model for the first time on Wistar strain using IMQ as an inducing agent.
  3,618 138 1
Current status of in silico, preclinical and clinical study registries across the globe: A systematic review and meta-analysis
Hardeep Kaur, Phulen Sarma, Manpreet Kaur, Manisha , Anusuya Bhattacharya, Manisha Prajapat, Subodh Kumar, Ashutosh Singh, Rahul Singh, Harish Kumar, Prasad Thota, Ajay Prakash, Bikash Medhi
March-April 2021, 53(2):160-169
DOI:10.4103/ijp.ijp_1090_20  PMID:34100401
Introduction: Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and presented data regarding clinical study registries, preclinical, in vitro and in silico study registries across the globe. Materials AND METHODS: We searched via Google Search Engine with appropriate keywords e.g. name of country (n = 198), name of continent (n = 7), registry, study registry, animal, in silico, virtual, simulation, preclinical, animal, clinical trial. The overall pooled prevalence of clinical study registries and WHO primary registries in per continent was calculated using Medcalc software. Results: The overall pooled prevalence of clinical study registries were 13% in each continent. The prevalence of WHO primary study registries were 8.9% of the countries per continent. Overall, there are 17 primary registries associated with WHO ICTRP as primary registries, 2 partner registries and 6 registries are affiliated to ICMJE. However, the amount of preclinical animal study registry was quite less (n = 4). Regarding in vitro studies, only country specific in vitro fertilization registries were available, however, in other research domains, registries were absent. Only one simulation study registry was available. Conclusion: At priori study registration is essential to deal with selective reporting. Comparison between study protocol and final report allows us to know the protocol deviations and allows us to evaluate risk of bias and internal validity of the research findings. Although trialists are responsible for the completeness of records, yet the registries must have some measures for their periodic update and quality control of the data.
  2,727 90 -
Therapeutic potential of diosmin, a citrus flavonoid against arsenic-induced neurotoxicity via suppression of NOX 4 and its subunits
Rupasree Peruru, Sujatha Dodoala
March-April 2021, 53(2):132-142
DOI:10.4103/ijp.IJP_837_19  PMID:34100397
Objectives: Water contaminated with arsenic affected millions of people worldwide and arsenic exposure is related to various neurological disorders. Hence, the current study was planned to investigate the neuroprotective activity of diosmin (DSN) against arsenic induced neurotoxicity as an attempt to identify therapeutic intervention to combat arsenicism. Materials and Methods: Sodium arsenite an inducer of neurotoxicity was administered orally (13 mg/kg) and DSN treatment at two selected doses (50 and 100 mg/kg) was done for 21 days. Behavioral and biochemical variations were examined by various parameters. Furthermore, histopathological and immunohistochemistry studies were done with the brain sections. Results: The behavioral studies evidenced that arsenic has suppressed the exploratory behavior and motor coordination in rats and DSN treatment has recovered the behavioral changes to normal. Arsenic administration has also found to induce oxidative stress and DSN co-treatment has ameliorated the oxidative stress markers. Interestingly, depleted levels of neurotransmitters were observed with the arsenic and it was restored back by the DSN treatment. Histopathological alterations like pyknosis of the neuronal cells were identified with arsenic exposure and subsided upon DSN co administration. Immunohistochemical studies have revealed the expression of NOX4 and its gp91phox and P47phox subunits and its suppression by DSN treatment may be the key therapeutic factor of it. Conclusions: Treatment with DSN showed a beneficial effect in protecting against arsenic-induced neurotoxicity by suppressing the toxicity changes and the antioxidant effect of DSN might be attributed to its ability of suppressing NOX4 and its subunits.
  2,696 94 3
Questionnaire-based Pan-India survey for impact assessment of National Formulary of India
Sudhir Chandra Sarangi, Bikash Medhi, Ajay Prakash, Jai Prakash, Yogendra K Gupta
March-April 2021, 53(2):115-124
DOI:10.4103/ijp.ijp_353_21  PMID:34100395
Objectives: The National Formulary of India (NFI), a ready reckoner for medicines among healthcare-professionals aims for promoting rational drug use. This needs periodic update based on evidence-based medicines and suggestions from end-users. This study assessed the level of awareness among health-care professionals and sought suggestions for enhancement of utility/content of NFI. Materials And Methods: This pan-India cross-sectional, questionnaire-based survey was conducted between November-2020 and March-2021. A Google-doc-based validated questionnaire (20 questions) was circulated through E-mail/social media groups and to 311 medical institutes/hospitals/clinics across India through the adverse drug reaction monitoring centers under the Pharmacovigilance Program of India. Results: A total of 461 participants (39-interns, 167-resident doctors, and the rest practicing physicians/doctors) affiliated to 224 institutes/hospitals/clinics had responded. About 46% respondents consulted NFI for drug-related information and 82.3% stated that NFI provides balanced unbiased information. About 95% respondents were aware of NFI's content and 76% mentioned usefulness of NFI in their clinical practice; however, 34.4% had misconceptions about NFI, 28.7% had a false belief that NFI is a legal document to safeguard health-care providers and 22.2% had never used it. Suggestions to enhance NFI's utility included digital accessibility, incorporation of information like drugs for basic medical emergencies (71.3%), disposal of expired-pharmaceutical products (38.7%), pharmaceutical price control policy (36.3%), and drug-procurement practices in hospitals (35.6%). Conclusion: As per the survey findings, NFI is an effective tool for instant access to precise and unbiased drug-related information, and fostering rational use of drugs. Boosting its practical usefulness needs incorporation of suggested information, digital accessibility, and periodic update.
  2,657 122 -
Ropivacaine induced systemic toxicity in a patient with phacomatosis pigmentokeratotica
Ashish Aditya, Paritosh Amar, Anjuman Chander, Nitika Goel, Kajal Jain, Tanvir Samra
March-April 2021, 53(2):153-156
DOI:10.4103/ijp.IJP_521_20  PMID:34100399
Calculation of the maximum recommended dose of local anesthetic minimizes the risk of Local Anesthetic Systemic Toxicity (LAST) when administrating multiple blocks for lower limb surgeries. Ropivacaine is the preferred local anesthetic as it is less lipophilic than bupivacaine and thus results in less central nervous system (CNS) and cardiovascular toxicity. The presence of developmental, congenital, and metabolic disorders mandates an extracautious approach in the administration of large volume of Local anaesthesia (LA) as the vascularity of the limb, levels of alpha-1-acid glycoprotein, and sensitivity of the sodium channels may be altered. This case report highlights successful resuscitation of a patient with Phacomatosis pigmentokeratotica after the development of CNS toxicity secondary to the administration of ropivacaine in ultrasound-guided combined lumbar plexus and sciatic nerve block. We identified some high risk patient profiles which should be vigilantly monitored to minimize the incidence of LAST.
  2,205 79 -
Liposomal amphotericin B-induced reversible ototoxicity in a patient with disseminated histoplasmosis
Ramadoss Ramu, Brijesh Sharma, Dheeresh Karunakara, Purnima Paliwal, Naman Bansal, Rajesh Satyapal Taneja
March-April 2021, 53(2):157-159
DOI:10.4103/0253-7613.316948  PMID:34100400
Amphotericin B (AmB) is a polyene antifungal agent used widely for systemic fungal infections. Infusion-related side effects, nephrotoxicity, and dyselectrolytemia are well-known adverse effects with the use of this drug. Liposomal preparation of AmB has less adverse events. However, ototoxicity due to AmB is scarcely mentioned in the literature. We report a case of disseminated histoplasmosis who was treated with liposomal amphotericin B (LAmB) and developed hearing loss during the treatment, which recovered after discontinuing the drug. This is a rare adverse effect of LAmB and reported only once from India, to the best of our knowledge.
  2,160 76 1
Antimicrobial prescribing in dental practice during COVID 19: Its impact on antimicrobial resistance
Mathur Apoorva, Gupta Yogendra Kumar
March-April 2021, 53(2):180-181
DOI:10.4103/ijp.ijp_303_21  PMID:34100407
  2,010 77 -
Fixed-dose combinations: An essential for rational preparation
Pugazhenthan Thangaraju, Shoban Babu Varthya, Sajitha Venkatesan
March-April 2021, 53(2):170-172
DOI:10.4103/ijp.IJP_133_19  PMID:34100402
  1,845 91 1
Dapagliflozin-induced long-term and severe anorexia and weight loss: An extraordinary case
Erkan Cure, Hakan Sirin, Medine Cumhur Cure, Dursun Ali Sahin
March-April 2021, 53(2):174-175
DOI:10.4103/ijp.IJP_785_19  PMID:34100404
  1,793 79 -
Modified drug regimen for ophthalmic anesthesia during COVID-19 pandemic: Revisiting pharmacological concepts
Bharat Gurnani, Kirandeep Kaur
March-April 2021, 53(2):178-179
DOI:10.4103/ijp.ijp_89_21  PMID:34100406
  1,627 56 -
Randomized trial of vilazodone versus sertraline in depression: concerns and comments
Samir Kumar Praharaj
March-April 2021, 53(2):176-177
DOI:10.4103/ijp.IJP_288_20  PMID:34100405
  1,337 68 -
Unmet needs of corneal collagen cross-linking
Tapasya Singha
March-April 2021, 53(2):173-173
DOI:10.4103/ijp.IJP_450_19  PMID:34100403
  959 42 -
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