International Journal of Basic & Clinical Pharmacology
Not a member yet
3901 research outputs found
Sort by
Physicochemical characterization of ferric carboxymaltose brands in India: relevance to anemia management in chronic kidney disease
Full text linkBackground: Ferric carboxymaltose (FCM) is widely used in the management of anemia associated with chronic kidney disease. The therapeutic efficacy and long-term safety of FCM related to free iron mediated toxicity can be influenced by its physicochemical properties. This study aimed to compare physicochemical properties across various FCM brands available in India.
Methods: Samples of FCM from 6 different manufacturers were procured including Dr. Reddy’s FCM brand injection Irny and subjected to a series of laboratory tests. Key quality attributes like carbohydrate content, molecular weight, etc. were analysed using validated methodologies and compared with USFDA reference-listed drug (RLD) Injectafer.
Results: The carbohydrate content of Dr. Reddy’s injection Irny (8.78%) was comparable to USFDA RLD (8.2%), whereas other brands showed variability ranging from 4.38% to 10.56%. Molecular weight of Irny (2.74 lakh) was also in line with USFDA RLD (2.94 lakh), with other brands mostly exhibiting lower molecular weights. Zeta potential of injection Irny (0.17 mV) closely matched that of USFDA RLD (1.25 mV), while other brands showed more negative values ranging from -0.70 mV to -27 mV. Degradation kinetics (T75 value) of injection Irny (19.14 minutes) were similar to USFDA RLD (18.34 minutes), while other brands demonstrated longer degradation times (21 to 52 minutes).
Conclusions: Study highlighted notable variability in physicochemical properties of different FCM brands. Dr. Reddy’s injection Irny closely aligns with the USFDA RLD Injectafer quality attributes, suggesting comparable potential clinical outcomes and long-term safety. The observed differences among other brands may influence their bioequivalence and long-term safety
Drug utilization study of drugs prescribed in patients suffering from chronic obstructive pulmonary disease attending the pulmonary medicine outpatient department of a tertiary care hospital-an observational study
Full text linkBackground: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder requiring long-term pharmacological management. This study aimed to evaluate prescription patterns, drug utilization, polypharmacy and cost analysis in COPD patients attending the outpatient department of a tertiary care hospital.
Methods: This single-center, cross-sectional observational study was conducted in collaboration with the Department of Pulmonary Medicine. A total of 600 prescriptions of COPD patients were analyzed over 18 months (January 2020–June 2021) following WHO guidelines for Drug Utilization Studies. Adult patients diagnosed with COPD and attending the outpatient department were included. Data on demographics, drug classes, fixed-dose combinations (FDCs), essential drug listing and cost burden were collected and analyzed using descriptive statistics.
Results: The average age of patients was 62.87±14.52 years, with 84.67% being male. A total of 3815 drugs were prescribed, with bronchodilators (62.70%) being the most common class, followed by corticosteroids (8.10%). Tiotropium bromide and Salbutamol were the most frequently used individual drugs. The average number of drugs per prescription was 6.36±2.31, indicating polypharmacy. Fixed-dose combinations such as Theophylline+Etophylline (41.87%) were commonly prescribed. The average prescription cost was 647.23 INR, of which 44.90% was borne by patients. Most drugs (69.78%) were prescribed by generic names and 62.43% were from the National Essential Medicines List.
Conclusions: This study highlights a significant degree of polypharmacy and suggests that while prescribing trends largely align with GOLD guidelines, greater access to essential drugs through hospital pharmacies and efforts to reduce patient cost burden are warranted
Analysis of adverse event reporting patterns following COVID-19 vaccination: findings from VigiAccess, FAERS and EudraVigilance databases with comparative assessment of data representation and categorization across three databases
Full text linkThe clinical presentation of COVID-19 varied from mild to severe or fatal illness, and vaccination played a pivotal role in preventing the spread of severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2). Despite cumulative evidence suggesting that the benefits of COVID-19 vaccination outweighed the risks, evaluating its safety profile remained imperative. This study aimed to analyse adverse events following immunization (AEFI) after COVID-19 vaccination using three pharmacovigilance databases and to assess how these data were categorized and represented. A cross-sectional observational study was conducted in January 2024 using VigiAccess (WHO), FAERS (U.S. FDA), and EudraVigilance (EMA). The total number of reported AEFI cases for COVID-19 vaccines were 55,49,876 in VigiAccess, 11,640 in FAERS, and 23,16,918 in EudraVigilance. The most common reaction group in all three databases was general disorders and administration site conditions (VigiAccess 59.07%, FAERS 62.57%, EudraVigilance 62.67%). The most frequently reported reaction in VigiAccess was headache (22.73%), while fatigue (19.79%) was the most common reaction in FAERS. VigiAccess grouped AEFIs for different COVID-19 vaccines under the general term “COVID-19 vaccine,” whereas FAERS and EudraVigilance categorized adverse events by specific vaccine types. All three databases categorized individual case safety reports (ICSRs) data, but only FAERS and EudraVigilance categorized the AEFI data. Overall, the comparative analysis revealed that the most commonly reported adverse reactions were consistent across the three databases, while also highlighting significant differences in how these databases represented and categorized the data
Severe agranulocytosis during prolonged trimethoprim-sulfamethoxazole therapy in an elderly male: a case report with causality assessment and literature review
Full text linkIdiosyncratic drug-induced agranulocytosis (IDIA) is a rare but potentially life-threatening adverse drug reaction, most frequently associated with antithyroid drugs, clozapine, and certain antimicrobials. Trimethoprim–sulfamethoxazole (TMP–SMX), commonly prescribed for urinary tract infections (UTIs), carries a documented risk of agranulocytosis, particularly in elderly patients. We describe an 84-year-old male admitted for post-critical illness rehabilitation who developed severe febrile agranulocytosis during prolonged TMP–SMX therapy for UTI. Due to a documentation error following physician rotation, TMP–SMX (80/400 mg, two tablets every 12 hours) was administered for 31 days. On hospital day 24, he developed fever (39.4 °C), diffuse erythematous rash, leukocytes 1.2×109/l, absolute neutrophils 0.01×109/l, lymphocytes 0.52×109/l, and CRP 112 mg/l. TMP–SMX was discontinued and replaced by ciprofloxacin, later cefuroxime, while the patient was transferred to an infectious diseases unit where filgrastim (G-CSF) was initiated, resulting in normalization of leukocytes (7.6×109/l) and neutrophils (4.46×109/l) within seven days. Causality assessment using the Naranjo algorithm yielded a score of 7, consistent with a probable association. This case underscores the importance of accurate antibiotic stop-dates, baseline and periodic complete blood count monitoring during prolonged TMP-SMX therapy, and prompt recognition and management of febrile agranulocytosis in elderly patients.
Protease sink vs. direct inhibition: mechanistic insights and clinical evidence for MMP-targeted dressings in hard-to-heal wounds
Full text linkChronic wounds are characterised by excessive matrix metalloproteinase (MMP) activity and impaired remodelling of the extracellular matrix (ECM). Dressing marketed as MMP inhibitors aims to restore protease balance, but their mechanism and clinical efficacy differ.
This review bridges the mechanistic and clinical perspectives by comparing collagen and oxidized recombinant cellulose (ORC) matrixes (protease inhibitors) with TLC-NOSF (technology lipids with nano-oligosaccharide factor). Collagen-based creams act passively as a protease sink, as a binding medium for MMPs and as an inflammatory mediator, but their clinical effectiveness is inconsistent, with most randomised studies not showing any significant improvement in complete healing. In contrast, TLC-NOSF directly inhibits MMP-2 and MMP-9, stabilises growth factors and consistently improves wound sealing and area reduction in high-quality blinded clinical trials. Mechanism of action predicts clinical outcome: passive binding to protease (collagen) provides modest, variable benefits, while active, specific inhibition (TLC-NOSF) is correlated with reproducible efficacy and support from guidelines. Mechanistic-clinical integration underlines the importance of selection of dressings based on biological plausibility as well as experimental evidence.
Evaluation of effectiveness of practical assessment by objective structured practical examination and its comparison with traditional pharmacology practical examination among II MBBS students: a cross-sectional study
Full text linkBackground: The undergraduate medical curriculum in India has adopted a competency-based medical education (CBME) model emphasizing cognitive, affective, and psychomotor domains to produce competent Indian medical graduates. Traditional pharmacology practical assessments, based on written exercises and viva voce, often lack objectivity and clinical relevance. The objective structured practical examination (OSPE) offers a structured, reliable, and competency-based alternative aligning with CBME principles.
Methods: This prospective cross-sectional educational study was conducted from March - July 2025 among 150 II MBBS students at Government Medical College in India. Students were randomly divided into two groups (n=75 each) and assessed through OSPE and traditional practical examination (TPE), respectively. OSPE included 11 structured stations evaluating cognitive, psychomotor, and affective domains using validated checklists, while TPE followed conventional methods. Quantitative data were analyzed using the unpaired Student’s t-test, and student perceptions were collected through a structured feedback questionnaire.
Results: Students assessed by OSPE scored significantly higher (mean±SD = 40.45±4.74) than those assessed through TPE (36.80±5.63; p<0.001). Over 90% of students found OSPE well-structured, fair, and relevant; 67.1% perceived it as less stressful, though 21.1% reported anxiety and 32.9% desired more faculty support. Reliability of feedback tools was high (Cronbach’s α=0.96 and 0.80).
Conclusions: OSPE is a valid, objective, and student-preferred assessment tool that enhances the evaluation of pharmacological competencies. Its wider implementation, supported by faculty training and student orientation, can significantly strengthen CBME-based pharmacology education
A study on prescribing pattern of medications for chronic disorders in community setting
Full text linkBackground: Non-communicable diseases (NCDs) or chronic disorders are preventable and costly conditions which are a leading cause of mortality worldwide. Monitoring and evaluating prescribing patterns provide crucial insights into current medication trends, usage, and emerging practices, informing necessary modifications.
Methods: This was a prospective cross-sectional observational study conducted over six months in community pharmacies in Mysuru. Patients diagnosed with chronic disorders who visited community pharmacies and who met the study criteria were enrolled. Data was collected from prescriptions, patient/caretaker interviews, medical records, and medication strips. Disorders were classified using ICD-10, and drugs were classified based on ATC classification to assess prescribing patterns.
Results: A total of 511 patients were enrolled, with a mean age of 56.4 years and a male predominance. Diseases of the circulatory system were the most common, followed by endocrine, nutritional, and metabolic diseases. Cardiovascular system drugs were most frequently prescribed, followed by those for the alimentary tract and metabolism. The most common comorbidity was T2DM with HTN.
Conclusions: Prescribing patterns for chronic diseases vary across regions in south India. In chronic disorders, where patients are on lifelong medication, patient adherence, counselling on potential side effects and correct medication usage are essential. This study highlighted the need for continuous monitoring of prescribing practices to ensure optimal patient outcomes and rational drug use in community settings
A prospective observational study on loop diuretic utilization in a tertiary care hospital setting
Full text linkBackground: Loop diuretics are essential for managing fluid overload in conditions like heart failure and chronic kidney disease. However, data on their utilization and adverse outcomes in resource-limited settings are scarce. To evaluate utilization patterns, adverse drug reactions (ADRs), and outcomes of loop diuretic therapy in a tertiary care hospital.
Methods: A prospective observational study was conducted on 100 inpatients from January 2023 to October 2023. Data on demographics, clinical indications, ADRs, and prescription patterns were analyzed.
Results: Furosemide was most prescribed (70%), followed by torsemide (20%) and bumetanide (10%). Main indications included congestive heart failure (40%), hypertension (24%), and chronic kidney disease (20%). Common ADRs were hypokalemia (16%), hypotension (10%), and dehydration (6%). Symptomatic improvement was noted in 70% of cases, with 20% showing no change and 10% worsening. Economic costs exceeded ₹1,000/month for 30% of patients, despite high medication adherence (80%).
Conclusions: Furosemide remains the most used diuretic, but ADRs and economic burdens highlight the need for regular monitoring and cost-effective strategies. Personalized therapy can optimize outcomes, and further multicenter studies are required for broader insights
Evaluating undergraduate understanding of dental anatomy, histology and oral pathology: a survey-based study
Full text linkBackground: Dentistry is a progressive field of medicine focused on studying, diagnosing, preventing, and treating diseases and disorders of the oral cavity and maxillofacial region. While an understanding of anatomy and histology is crucial for dental practice, dental students often view oral histology, oral anatomy, and oral pathology as less important for their careers and more difficult to grasp. However, a deeper knowledge of this subject enhances comprehension and aids in the diagnosis and treatment of cases. Still, there remains a gap in understanding and interest among students. This may be partly attributed to the perception that these subjects are non-clinical and offer limited opportunities for practical application. The study aims to assess undergraduate students' comprehension of dental anatomy/histology and oral pathology and identify specific areas where they encounter difficulties connecting with the subject matter.
Methods: This question-based cross-sectional study was conducted in the institute, and it included 116 undergraduate students.
Results: The Chi-square analysis revealed several significant associations between the academic year of students and their responses to questions related to oral pathology, dental anatomy, and forensic odontology.
Conclusions: The quality of education must be upheld, with a focus on creating a nurturing and supportive learning environment. This can be achieved through gathering student feedback and continuously refining the curriculum
Comparative evaluation of dexmedetomidine with tramadol for post spinal anaesthesia shivering: a prospective randomized comparative study
Full text linkBackground: Shivering after spinal anaesthesia is an unpleasant complication that also results in increased oxygen demand. Researchers have looked at various dosages of tramadol to see whether it helps with shivering after spinal anaesthesia. We compared dexmedetomidine with tramadol 1 mg/kg for the management of post-spinal anaesthesia shivering.
Methods: We selected 50 patients who developed shivering after subarachnoid block and split them in half; each group had 25 individuals. One group was administered 1mg/kg intravenous tramadol diluted in 100 ml normal saline, while the other group received 0.5 mcg/kg of dexmedetomidine diluted in 100 ml normal saline. Response time, defined as the duration until shivering stopped after drug administration, was the primary outcome measure. Response rate (defined as a complete cessation of shivering within 15 minutes of administering the drug), recurrence of shivering, changes in clinical parameters and pharmacological side effects were considered secondary outcomes.
Results: When compared to tramadol (8.91±1.36 minutes), dexmedetomidine (6.74±1.38 minutes) had a considerably shorter response time (p<0.001). Both groups showed a 96% response rate and 8% recurrence of shivering. There was 1 case of hypotension with dexmedetomidine and 2 cases of nausea with tramadol. All patients in group T recorded a sedation level of 1, whereas all patients in group D recorded a sedation score of 2 (p<0.001).
Conclusions: Both dexmedetomidine and tramadol are effective in treating post spinal anaesthesia shivering, but the time taken for shivering to stop completely was significantly lesser with dexmedetomidine(0.5 μg/kg) than with tramadol(1 mg/kg)