International Journal of Basic & Clinical Pharmacology
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Analysis of cutaneous adverse drug reactions in a tertiary care hospital in South Tamil Nadu
Get PDFBackground: Cutaneous adverse drug reactions (CADRs) are among the most frequently reported adverse drug reactions (10 to 30%) with overall incidence of 6.2/1000 cases in India and 8% of hospitalisation among Dermatology inpatients. The aim was to analyse the CADRs with reference to its prevalence, causative drugs, morphological patterns, polypharmacy and drug reaction severity by Hartwig’s severity assessment scale.Methods: This study was a retrospective study done in the Department of Dermatology, Venereology and Leprosy (DVL) over a period of 5 years (2015 to 2019) from CADR registers. Mean, standard deviation and chi square test were used for statistical analysis. P≤0.05 was considered as statistically significant.Results: A total of 134 cases of CADRs were encountered which comprised 0.2% (2/1000) of total OP census with equal gender ratio and involved most commonly the younger adults. The drug groups mainly responsible were anticonvulsants (24.7%) followed by non-steroidal anti-inflammatory drugs (NSAIDS) (22.5%), antibiotics (20.9%) followed by antiretrovirals (ART) and antituberculous drugs (ATT). The common morphological patterns were acute exanthem (32.2%), exfoliative dermatitis (14.9%) and toxic epidermal necrolysis (14.2%). Over the counter drugs accounted for 25.6% of cases. Around 38.1% were on polypharmacy. In this study, 15.7% had mild CADR, 53.7% had moderate and 30.6% had severe drug reactions with 2.2% mortality based on the Hartwig’s severity assessment scale. Commonest cause of severe CADRs was anticonvulsants and benign CADRs was NSAIDS.Conclusions: Proper history taking and documentation of data, recollection of sequence of events by the patient and drug re-challenge will help us in deciding the causative drug preventing further occurrence
Challenges of incorporating e-learning in medical education-a review
Get PDFIn this modern era of electronic gadgets learning is made easy and more effective using the electronic media. E-learning is it really a boon or a burden for medical education and the educators? E-learning is defined as learning mediated by technology, such as the world wide web, internet, and multi-media, based computer applications. All peer reviewed journals articles from 2009 to 2022 that reported the challenges of implementation of the e- learning were included in the study. The search was completed by three researchers over a period of 1 month from databases like Scopus, Medline, biomedical central and Google scholar. Term used for online search was “e-learning” in medical education. The common challenges in e-learning are lack of skills, inadequate time, poor infrastructure, poor communication and negative attitude of the educators. These challenges can be overcome by developing necessary skills, adopting new tools, and by better communication and having a positive attitude. E-learning in medicine is a relatively new concept. Hence it becomes imperative that the national medical council at the policy making and enforcing level become more vigilant on the fact that whether the respective Institutions are effectively using the e-learning platform for the benefit of the students or not. Whether the institutions are effectively providing all the technologies, teacher training, teaching aids for the medical teachers or not. Finally, whether the medical teachers are receptive of the new changes and willing to make better use of e-learning for the benefit of students
Antiplasmodial activity of the ethanol extract of Dacryodes edulis leaf in Plasmodium berghei infected mice
Get PDFBackground: Malaria treatment in Africa is increasingly becoming difficult resulting from Plasmodium falciparum resistant to available antimalarial agents. Therefore, evaluating plants used in traditional medicines can lead to alternative treatment against malaria.Methods: This study evaluated the antiplasmodial activity of ethanol extract of Dacryodes edulis in chloroquine sensitive Plasmodium berghei NK65 strain in mice. The 4-day suppressive test, repository and curative effect against established rodent malaria infection models were assayed in this study. The oral acute toxicity test and phytochemical screening were also carried out on the ethanol leaf extract.Results: The ethanol leaf extract of Dacryodes edulis (D. edulis) at varying doses of 100 mg/kg, 200 mg/kg, 400 mg/kg significantly (p<0.05) exhibited dose-dependent decrease in parasitaemia at suppressive, repository and curative studies. Chloroquine 10 mg/kg significantly (p<0.05) decreased parasitaemia levels in the three models of malaria infections. The antiplasmodial activity of the leaf extract is comparable with the standard drug. The extract was found to be non-toxic acutely in mice.Conclusions: The findings show that D. edulis ethanol leaf extract demonstrated high antiplasmodial activity in a dose-dependent fashion. Thus, supporting claims of the plant traditional therapeutic importance for malaria treatment, and can be developed as an alternative therapy against the disease
A clinical pharmacological evidence-based analytical research study on the clinical pharmacokinetic dose-dependent correlation of oral haematinics with the obstetric and gynaecological global anaemic patients’ recovery rate
Get PDFBackground: The goal of iron therapy is to repair the haemoglobin deficit and replenish storage iron. Oral haematinics are the treatment of choice, due to their higher effectiveness, higher safety, higher ease of administration, higher patient compliance, better accessibility, no occurrence of nosocomial infections and lower cost. This analytical evidence-based clinical research was conducted for the molecular pharmacokinetic study of the pharmacological response and adherence of the patients to oral haematinics, in global tertiary medical care centres.Methods: 100 anaemic patients, who were treated for moderate iron-deficiency anaemia, were prescribed oral haematinics, such as, ferrous ascorbate, ferrous sulphate, ferrous fumarate and ferric ammonium citrate, containing 60 mg of elemental iron, once to thrice daily, with or after meals, according to the progress of the disease, treatment regimen scheduling, occurrence or non-occurrence of adverse drug reactions and prognosis of the patient. The pharmacokinetic dose-dependent percentage recovery rate of the patients on 1st (30th day), 2nd (60th day) and 3rd (90th day) months and follow-up (105th day) visits, was finally deduced from the patients’ recovery features of symptoms and signs, and the confirmatory laboratory investigations recordings, with the efficacy and safety evaluation findings.Results: During the oral haematinics treatment, the pharmacokinetic dose-dependent percentage recovery rate of the patients was 29% on 30th day, 62% on 60th day, 93% on 90th day and 100% on 105th day of treatment.Conclusions: All the oral haematinics treated global anaemic patients had shown 100% recovery rate in tertiary medical care centres
Post-valuation quality check of multiple-choice questions
Get PDFBackground: Multiple choice questions find important place in assessment in medical curriculum. Each MCQ is called item. Item analysis is quality check of MCQs after valuation of response sheets. This serves to recognize flaws in MCQs so that the given questions can be preserved in question bank, modified or deleted. Methods: 140 medical students of second MBBS were assessed pharmacology through 20 single best response type MCQ. Post exam validation of MCQs was done by item analysis. Each item was analyzed for level of difficulty, ability of the question to discriminate between poor and good performing students and distracter effectiveness.Results: Score ‘1’ was given for correct and ‘0’ for incorrect or no response. The mean score of the test was found to be 10.58±2.48, with a range 5-18. The whole test had an acceptable difficulty level with 43.25±17.81 mean difficulty index. The discrimination index of the whole test was found to be 0.123±0.184 mean PBI correlation coefficient, which is not satisfactory. Out of 60 distractors, 51 were found to be functional, hence distractor efficiency of the given test was 85%±19.96% which is acceptable.Conclusions: 60% questions were found to be ideal and 25% were acceptable with revision of stem or options. One question was easy with poor discrimination which needs major modification in construct or subject to be placed in question bank while another one question was difficult but had negative biserial index which needs to be deleted from the question bank
Chronopharmacology: an insight into its knowledge among medical students
Get PDFBackground: Chronopharmacology is the science which deals with the optimization of drug dose that promotes efficacy and minimizes the adverse effects by taking the medications in relation to the biological rhythm. Circadian rhythms can be manipulated to treat certain disorders through chronotherapy. The aim of the study was to explore this knowledge of chronopharmacology and to give an insight about it among medical students.Methods: This was a cross sectional study conducted across students of different medical colleges in India by giving semi structured questionnaire.Results: A total of 208 participants (74 males, 134 females) from different batches of MBBS were participated. Majority of them are aware about the term chronopharmacology but their lack of apprehension on chronotherapy was evident throughout the study.Conclusions: There is an inadequate knowledge on chronopharmacology among medical students. Introducing this as a part of undergraduate curriculum can bring out a significant change in the practice of modern medicine.
A study of adverse drug reactions in tuberculosis patients in a tertiary care hospital
Get PDFBackground: Tuberculosis is the most rambling communicable infectious disease on earth. It is the single most common cause of death in individuals aged 15-49 years. Adverse drug reactions to antitubercular drugs causing significant morbidity, mortality, incurring substantial additional costs because of added outpatient visits, tests, and hospitalizations. Study was carried out with objectives of assessing the rate and type of adverse drug reactions (ADRs) and detecting serious and preventable ADRs with collection of demographic details of patients taking antitubercular drugs and developing ADRS.Methods: A cross sectional, prospective, observational study conducted in department of chest and TB of a tertiary Health care and teaching hospital in both IPD and OPD patients for a period of 18 months. 480 patients monitored.Results: Among 480 patients 120 i.e., 25% developed ADR. frequency being significantly higher in males (58%) and adult age group (>18 years) amongst hospitalized comparing to outdoor patients the gastrointestinal tract [GIT] (39%) followed by, generalized body disorders (19%) hepatobiliary system (17%) were organ systems most affected Majority (56%) ADRs reported in 0-2 month of starting therapy (63%) of cases were in “probable according to Naranjo causality assessment (37%) being possible. 55% ADRs were moderate in severity followed by 36% mild and 9% severe. 30% of ADRs were definitely preventable followed by 20% of probably prevented according to schumock thronstone preventability scaleConclusions: Study highlights the importance of routine monitoring and robust pharmacovigilance system for success of national tuberculosis programmes in India as well as worldwide
Assessment of the pharmacokinetics, safety, and tolerability of levothyroxine sodium in healthy Indian volunteers
Get PDFBackground: Few studies have assessed the pharmacokinetics of various marketed formulations of levothyroxine available in the Indian market. Here, we assessed the pharmacokinetics and safety of Thyronorm® 100 in healthy Indian volunteers.Methods: The primary and secondary objectives were to determine the pharmacokinetic profile and to monitor safety and tolerability of 600 µg of levothyroxine, respectively. Eligible subjects received a single oral dose of 6×100 µg of levothyroxine, and pharmacokinetic profiles were monitored up to 432 hours post-dose. Safety assessments included exposure of study drug and incidence of adverse events (AEs) and serious AEs. The mean plasma concentration of LT4 versus time profile was presented on both untransformed and log-transformed scales.Results: Of 20 enrolled subjects, 1 was discontinued due to an AE of pain, unrelated to study drug. The mean [standard deviation (SD)] age and body mass index of subjects were 35.7 (6.33) years and 25.0 (3.0) kg/m2, respectively. Following baseline correction, the mean maximum observed drug concentration (Cmax) and area under the plasma concentration-time curve measured to the last quantifiable concentration (AUC0-t) of free thyroxine were found to be 68.4 (12.09) ng/ml and 6760.0 (2065.05) ng×hr/ml, respectively, with an elimination half-life (t1/2) of 205.6 (180.26) hrs and a residual area of 24.6%. The median time to first observed maximum drug concentration (Tmax) was 2.5 (1.5-2.5) hrs.Conclusions: These parameters were in accordance with those of other marketed formulations and confirmed the pharmacokinetics and safety of Thyronorm® 100 in healthy volunteers from India
Adverse drug reaction due to combination of gabapentin and nortriptyline along with its causality assessment
Get PDFThe combination of gabapentin and nortriptyline is used as the first line drug treatment for management of neuropathic pain; however adverse drug reactions (ADRs) are one of the main causes for discontinuation of the therapy. This is a case study of erythematous maculopapular rash induced by combination of gabapentin and nortriptyline along with its causality assessment. A 55-year-old female came with complaint of back pain for 1 month. She was diagnosed as a case of L1 acute osteoporotic disc compression fracture. The patient was then administered combination tablet of gabapentin and nortriptyline (100 mg/10 mg) orally for the neuropathic pain. After 3 days she developed erythematous maculopapular rash on face, upper limbs and back. Following this the drug was then discontinued and pheniramine, hydrocortisone and combination tablet of levocetirizine and montelukast was administered to treat the rashes. Causality assessment was done using the Naranjo scale and WHO UMC assessment scale. The ADRs was reported by VigiFlow in the pharmacovigilance centre. Causality assessment using Naranjo scale (Score 6) and WHO UMC scale indicates probable relationship. Hence, monitoring is essential for any ADRs while using combination of gabapentin and nortriptyline therapy. In case of ADRs, discontinue the therapy and report the adverse drug reactions to pharmacovigilance centre
Cross sectional observational study to assess the knowledge of drugs utilized in emergency medical conditions amongst medical interns and residents in tertiary care teaching hospital
Get PDFBackground: Medical interns and residents are future medical professionals and as first-line responders, they may confront any type of emergency. Knowledge of pharmacotherapeutics (PTs) is the backbone of emergency care. Therefore, this study is designed to assess PTs’ knowledge and identify the lacunae in handling various medical emergencies among medical interns and residents.Methods: This was a cross-sectional, observational, questionnaire-based study. A self-structured questionnaire containing 30 close-ended questions, assessing the knowledge of drugs utilized in various medical emergency conditions was prepared and circulated in the form of a Google form. A credit score of “1” was given for each correct response. Grading of knowledge was done as “poor” (≤50%), “average” (>50-70%), and “adequate” (>70%-100%) The student’s unpaired t-test was used to analyse the data.Results: A total of 282 candidates responded, with 148 (52.48 %) interns and 134 (47.52%) residents. Participants had the least knowledge of PTs for anaphylactic shock. Participants’ knowledge of PTs was found to be adequate regarding the central nervous system and electrolyte disorders while average regarding toxicology, immunization, and endocrine system. Results suggested that residents (mean score: 21.42±5.06) were significantly (p=0.0165) more knowledgeable than interns (mean score: 19.96±5.08). Among respondents, 17.6% of interns and 13.4% of residents had poor performance while 45.9% of interns and 53.7% of residents had adequate performance.Conclusions: The current study provides valuable information regarding the state of PTs’ knowledge in medical emergencies among interns and residents, which can be used to improve undergraduate as well as postgraduate training.