International Journal of Basic & Clinical Pharmacology
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Clinical trials in pediatrics-review of ethics and law
Get PDFChildren were acknowledged as ‘therapeutic or pharmaceutical orphans’ in 1960s, since then there has been a worldwide recognition of the need to conduct clinical trials in children, to improve their health. Prescribing in children is often based on extrapolation of trial results from adults, due to the lack of paediatric data. Children have different pharmacokinetic and pharmacodynamics responses as compared to adults. Hence extrapolating the adult safety and efficacy data and using it for prescribing in children can have disastrous effects. Relevant literature on clinical trials in paediatrics was gathered and scrutinized with emphasis on legal and ethical perspectives. This research is an exploratory attempt which surveys and summarizes previously published studies simultaneously trying to answer few research questions which addresses the current debates and scenario. Common problems encountered during pediatric clinical trials are unnecessary scrutiny of even minimal risk studies, difference in interpretation of research protocol in multicentre trials causing delay in trials, prolonged review process. The proposed changes to overcome the above mentioned drawbacks are standardized data security protections, enforcing universal ethical principles for conducting pediatric trials, sstandardizing adverse drug reaction reporting to regulatory bodies. There is a need to increase the number of clinicians actively involved in pediatric research. All the stake-holders such as regulators, parents, ethics committees, research institutions, investigators, sponsors, media, pharmaceutical companies and scientists have to collaborate to ensure that ethical pediatric research is promoted, equipping them with knowledge needed to provide optimal care to their patients
Prevalence of pulmonary arterial hypertension in severe chronic obstructive pulmonary disease patients attending tertiary care centre Ernakulam
Get PDFBackground: Chronic obstructive pulmonary disease (COPD) is an irreversible bronchial inflammation of lung airways and parenchyma. Various factors play an important role in occurrence and severity of pulmonary arterial hypertension (PAH), a common in severe COPD. The objective of the study is to know the proportion of PAH in patients with severe COPD and to find the association between various factors.Methods: 180 cases of severe COPD patients admitted in Government Medical College Ernakulum from January 2019-December 2019, were enrolled into this cross-sectional descriptive study. Subject’s history, clinical examination, anthropometric measurements, vitals, Arterial Blood Gas (ABG) analysis were done.Results: Among 180 subjects, 148 (82.22%) had mild PAH, 22 (12.22%) subjects had moderate PAH and 10 (5.56%) had severe PAH. Use of accessory muscle was the most elicited sign in the study with 174 (96.67%). 170 (94.44%) had cough and 169 (93.89%) had breathlessness which were the most reported symptoms. Demographic variables and clinical features had no significant mean pulmonary artery pressure (mPAP) association. Grade 3 PAH groups were elder than others, which was statistically significant (p<0.047). FEV1, Oxygen Saturation and ejection fraction were lowest in grade 3 PAH subjects. Respiratory rate, hemoglobin, PCV, tricuspid velocity, PaCO2 were highest in grade 3 PAH subjects being statistically significant (p<0.0001).Conclusions: In our study, majority of severe COPD patients had mild PAH. There was an independent correlation between respiratory rate, hemoglobin, PCV, tricuspid regurgitant velocity and PaCO2 with severity of PAH
Evaluate the prevalence of risk factors among patients of myocardial infarction in our population: review of one hundred forty-seven cases
Get PDFBackground: CAD is disease of persons older than 45 years of age. In India, CAD in males, it manifests earlier than west European and North American males. This study is designed to study prevalence of risk factors (and angiographic profiles) amongst patients of Myocardial infarction in our population. Methods: Total of 147 consecutive patients of AMI were studied for risk factors.Results: Out of 147 patients, 116 (79%) were males and 31 (21%) were females. 11 (9.5%) of males and 01 (3.2%) of females were below 40 years of age. Whereas 34 (29.3%) of males and 06 (19.4%) females were of below 50 years of age. Median age for males was 54 years while that for females was 63 years. Smoking remains most prevalent amongst males while high LDL and HT remain most prevalent amongst young and overall females respectively. 108 patients had STEMI while 39 had NSTEMI.Conclusions: AMI occurs much frequently in males. Median age for males is almost one decade earlier than West European males and nearly 5 years earlier than North American males. Smoking is most common and hypertension second most common risk factors amongst males. In females median age for AMI is almost one decade later than Indian males. It is similar to North American females while nearly 5 years earlier than Western Europe females. HT and DM remain first and second common risk factors amongst females.
Efficacy of current treatments against hepatitis C virus
Get PDFIt is estimated that currently, in the world, approximately 3% of the population has chronic hepatitis, the hepatitis C virus is the etiological agent most related to the development of this pathology. The diversity of genotypes (7) and quasi-species of HCV, due to its high mutation rate, interferes with an effective humoral immunity. The aim of this work is precisely to evoke those usual drugs used in HCV therapy, as well as cutting-edge drugs. The goal of treatment is the eradication of HCV infection. One strategy offered by the WHO is to eradicate the virus in at-risk populations. Alternatives to the previously used treatment with interferon and ribavirin are shown in this paper; protease inhibitors and other targets have now been developed to make eradication of the virus more effective
A cross-sectional, questionnaire-based study on knowledge, attitude, and practice of pharmacovigilance among post-graduates at a tertiary care teaching hospital, Telangana
Get PDFBackground: Pharmacovigilance is the process of drug safety monitoring that improves patients' quality of life through the collection and analysis of Adverse Drug Reactions (ADRs). In our state, most of the ADRs are reported by a spontaneous reporting system of individual cases from health care professionals to Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India (PvPI). Post-graduates (PGs) play a vital role in reporting ADRs as they are in personal evidence with all events after drug administration. The main objective of our study is to evaluate the Knowledge, Attitude, and Practice of Pharmacovigilance among post-graduates.Methods: The present study was a cross-sectional questionnaire-based study on knowledge, attitude, and practice (KAP) of Pharmacovigilance among 150 post-graduates at a tertiary care teaching hospital, Telangana. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 25 software.Results: The results showed that there is relatively less knowledge among postgraduates. Attitude and practice-based questions evidenced a paradigm shift towards the construction of an organized Pharmacovigilance system. This study also highlights the under-reporting and the interventions needed to improve spontaneous reporting of ADRs.Conclusions: The knowledge of Pharmacovigilance with a positive attitude and practice among post-graduates is essential for reporting ADRs and reducing under-reporting.ng
Evaluation of safety and tolerability of iron amino acid chelate therapy in pregnant women
Get PDFBackground: Anemia is a major health problem. Iron deficiency is the most common cause of anemia during pregnancy. It can be associated with increased preterm labor, preeclampsia, and maternal sepsis. It can also lead to fetal loss or even perinatal deaths. The aim of the study was to monitor the oral iron therapy [Iron Amino Acid Chelate (IAAC) equivalent to elemental iron 30 mg] administered according to hospital practice and to determine the safety, and tolerability of IAAC in pregnant women.Methods: The data of pregnant women attending the outpatient department of the hospital for antenatal care between March 2020 and February 2021 and prescribed IAAC was retrospectively analyzed. It was of interest to note the changes in the Hemoglobin (Hb) levels and serum ferritin levels. These parameters were considered as the primary efficacy parameter and were analyzed by the paired t-test.Results: The data indicated very well tolerance to IAAC preparation with increase in Hb levels. After 12 week of treatment, there were significant increases in hemoglobin levels with mean rise in Hb level was 7 to 9 gm/dL. A statistically significant difference was observed at the 4th, 8th, and 12th weeks from the baseline value to each evaluation in the Hb level due to the supplementation of oral iron. The change in the serum ferritin levels was found to be statistically significant at the 12th week from the baseline values. Most of the women tolerated the oral IAAC preparationConclusions: This retrospective analysis showcased a significant improvement in the Hb and serum ferritin levels of pregnant women after 12 weeks
A case of severe bone-marrow suppression due to azathioprine in a patient of kidney transplant
Get PDFAzathioprine is one of the triple therapy immunosuppressive agents used in patients of renal transplant. Azathioprine is being used successfully in majority of patients of renal graft. But one of the dreaded complications caused by it is severe bone-marrow suppression. Here I am reporting a case of severe, life- threatening bone-marrow suppression in a 30 years old male patient of renal transplant. The case is very important and attention is needed to be given by health care professionals and by clinicians. The patient underwent renal transplant surgery in Indraprastha Apollo hospital, New Delhi. The patient was on immunosuppressive agents: prednisolone, cyclosporine and mycophenolate mofetil. After 10 months of renal transplant surgery, the patient was switched over azathioprine due to complains of GI upset due to mycophenolate mofetil. In initial 2 months there was moderate bone-marrow suppression, but afterwards there was severe bone-marrow suppression. Lastly TLC reached 300 /mm3 and Hb was 3.8 g/dL and that was life-threatening condition. The patient was managed in ICU with inj. Grafeel under strict hygienic conditions. The patient was recovered successfully with necessary conservative managements during admission. In my case, causality of azathioprine was “definite/ certain” as per Narenjo scale. Seriousness of the reaction was “life- threatening”
Asthma management with combination of fluticasone and formoterol: the Indian perspectiverspective
No full textAsthma is a major health problem globally that affects people across all the age groups. The prevalence of asthma is increasing worldwide, especially in the low- and middle-income countries. Asthma is controlled with inhaled corticosteroid (ICS) with as-needed or daily low-dose therapy. A step-up therapy to daily combination treatment with low- or medium-dose ICS/long-acting β-agonist (LABA) may be required for those with persistent symptoms. Asthma control levels are low despite the availability of many therapies. The efficacy of inhaled asthma therapy is dependent on the efficiency and reliability with which the drug is delivered to the lungs. Combination of an ICS and a LABA in a single inhaler is a safe, effective, and convenient treatment option for asthma management. Fluticasone and formoterol in combination ensure high potency action against anti-inflammation and rapid bronchodilation, and is a well-established ICS-LABA dual therapy. Rapid bronchodilator action of formoterol and fluticasone’s long-term action against inflammation are vital clinical attributes for optimal asthma maintenance treatment. Fluticasone/formoterol combination therapy is an efficacious and safe alternative treatment option for patients with moderate to severe asthma. The combination of the two in a single inhaler is beneficial with regards to ease of administration and patient compliance.
Abciximab induced severe thrombocytopenia in an elderly patient
Get PDFAbciximab is a humanized monoclonal antibody which acts against αIIbβ3 receptor. The use of abciximab with percutaneous coronary interventions (PCI) has proven good results in patients. The drug has been notorious to cause bleeding and also decrease in the number of platelets. In this case the patient had normal platelet count but the count decreased significantly after abciximab was given. A number of cases have been reported but very few have been reported from India. Hence, we found it important to report and it is a valuable asset for scientific research.
An audit of drug utilization patterns, rationality, and cost analysis of antimicrobial medicines in a tertiary care teaching hospital in central suburban India
Get PDFBackground: Antimicrobial medicine (AMM) utilization patterns and rational drug use are important topics in today’s world wrought with AMM resistance, irrational prescription of antibiotics, and lack of proper training such as stewardship programmes for medical graduates and general practitioners. Our objective was to perform an audit of the antimicrobial drug utilization pattern, evaluate the rationality of drug use, and perform a cost analysis of these drugs.Methods: An observational cross-sectional study design was implemented. The study location was a tertiary care teaching hospital in suburban central India. Patients were recruited from the general medicine and general surgery departments.Results: Out of 189 patients, the average age was 45.714 years and 67.725% were females. A total of 595 AMMs were prescribed to 189 patients with an average of 3.148±1.578 drugs per patient. 6.5% drugs prescribed were generic, 95% prescribed were included in the national essential medicine list, and 90% of patients’ prescriptions were rational. The total expenditure on AMMs was ₹726043.610, with a median expenditure of ₹987.320.Conclusions: Drug utilization patterns vary between medicine and surgery departments. They also vary between different institutions within the same country. Creating a structured standardized training program to uniformly train healthcare professionals in conservative antibiotic prescription practices is needed. This study hopefully paves the way for future studies to target critical areas in AMM prescription and to prospectively assess the impact of a structured antibiotic stewardship program on AMM utilization patterns