International Journal of Basic & Clinical Pharmacology
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Assessing the electrolyte imbalances, predisposing factors and their impact on sleep quality in chronic kidney disease patients: a hospital-based study
Get PDFBackground: Chronic kidney disease (CKD) poses a significant burden on patients' health and quality of life, often accompanied by various risk factors, electrolyte disturbances and disturbances in sleep patterns.
Methods: A prospective observational study was conducted in a tertiary care hospital inpatient general medicine department over a period of six months and recorded 120 cases. Pittsburgh sleep quality index (PSQI) was used to assess the quality of sleep and chi square test was performed as a statistical significance for the risk factors and complications and obtained the results.
Results: Out of 120 cases, 68 were males and 52 were females; patients with an age group greater than 65 years are more prone to CKD (p value <0.05, i.e., 0.048). Hypertension was the major risk factor, followed by diabetes, among these patients (p value <0.05). Anemia, sepsis, and edema are the most common complications among CKD patients. This study confirms that the majority of the patients have long-term sleep disturbances followed by poor sleep quality. Significant decrease in glomerular filtration rate, albumin levels, serum sodium, serum calcium levels, and an increase in serum creatinine levels, blood urea nitrogen, bilirubin levels, serum potassium, serum chloride and serum phosphate levels were observed in these CKD patients.
Conclusions: Study concluded that assessing sleep quality, monitoring electrolyte levels were essential for comprehensive care in CKD patients. Addressing sleep problems and managing risk factors can improve well-being, while maintaining electrolyte balance helps manage complications and prevent disease progression
Polyaminoacid: revolutionizing drug delivery through advanced nanocarrier systems
Get PDFPolyaminoacid are smart nanocarriers and striking aspirant material for drug delivery. Amino-acids can be effortlessly ionized positively or negatively. Commonly used polyaminoacid chains are polylysine, polyarginine, and polyglutamic acid. Polyaminoacid polymers can also be synthesized in the laboratory and are called synthetic polyaminoacid polymers. Polyaminoacid are sensitive to acidic pH and are degraded by acid and enzymes in the lysosome, the amino acids are released and the conjugated drug portion is also released. Block polymers are versatile and multifunctional in drug delivery. PEG-copolymers can be utilized for drug targeting, organ imaging and drug delivery purpose. Only water soluble polyaminoacid can be utilized for drug delivery and other biomedical applications. The advantage of using Polyaminoacid is that they are biocompatible, biodegradable, pH sensitive, provide nutrients to the tissue upon cleavage, are conjugated with drug, proteins, and antibodies, and can be amalgamated with other polymers such as chitosan, nanoparticle synthesis with other composite material is possible. The active drug loading is highly efficient, intracellular drug delivery possible, it can cross many physiological and anatomical barriers such as the blood brain barrier, self –assembled property, delivery of prodrugs etc. Biomedical applications include cancer cell targeting, gene transfer, gene delivery, siRNA transfer, miRNA, gene silencing, intraocular delivery, intracellular delivery, brain delivery, radiological imaging, bone tuberculosis, cosmetic use, colonic drug delivery, delivery of prodrug. Therefore, polyaminoacid are versatile in drug delivery systems
ABC-VED matrix-a dual approach to efficient inventory control at a tertiary care teaching hospital in India
Get PDFBackground: Inventory control is based on criticality criteria (VED) and on cost criteria (ABC). This underlines the need of strategically planning, creating, and arranging the pharmacy to ensure effective clinical and administrative services.
Methods: This retrospective observational cross-sectional study was conducted in the medical store of Government Medical College, Gondia, Maharashtra, over a one-year period (January-December 2023). A total of 142 drug items were analysed based on complete records of annual consumption and expenditure. ABC, VED, and ABC-VED matrix analyses were performed to categorize drugs. Data were analysed using Microsoft Excel 2019. Ethical clearance was obtained from the institutional ethics committee (approval number: 98/12/11).
Results: Category A drugs (26%) consumed 71.1% of the budget, indicating high expenditure on fewer items. Categories B and C accounted for 32.2% and 40.8% of items, with 22.8% and 6.1% expenditure respectively. VED analysis showed that vital drugs (29.5%) accounted for 24.8% of costs, essential drugs (51.2%) for 47.9%, and desirable drugs (18.3%) for 27.3%. The ABC-VED matrix revealed that category I drugs (47.88%) consumed 90% of the budget, highlighting the importance of monitoring high-cost and life-saving items.
Conclusions: ABC-VED needed to adopt as routine for optimal resource utility eliminates stock out situation in hospital medical store
Acute generalized exanthematous pustulosis induced by flupentixol-melitracen: a previously unreported drug reaction
Get PDFAcute generalized exanthematous pustulosis (AGEP) is a rare and severe cutaneous drug reaction, most often triggered by antibiotics or antifungals. Psychotropic medications are an uncommon cause. We report the case of a 60-year-old male who developed AGEP within 24-48 hours of initiating flupentixol-melitracen, a fixed-dose antipsychotic-antidepressant combination. Clinical features included widespread sterile pustules on an erythematous base, and histopathology confirmed the diagnosis. The eruption resolved rapidly upon drug withdrawal and topical corticosteroids. To the best of our knowledge, this is the first reported case of AGEP induced by flupentixol-melitracen. Clinicians should consider this rare association when evaluating drug-induced pustular eruptions.
Study of adverse drug reaction of intravesical onco-BCG in non-muscle-invasive bladder cancer: a retrospective study
Get PDFBackground: Intravesical onco-BCG is mainstay therapy for intermediate and high‑risk NMIBC to reduce disease recurrence and progression. In India Danish 1331 strain was used till middle of last decade after that Moscow (Russia) strain is used.
Methods: Retrospective study was conducted in intermediate and high risk NMIBC patients. Patients receiving were interviewed for ADR’s and were recorded as grade 1, grade 2, grade 3 symptoms (as per Cleveland clinic approach to management of BCG toxicity). The patients with NMIBC (Ta or T1 diseases as per TNM staging AJCC 8th edition) in intermediate and high-risk group were enrolled in the study. The diseases classified in low risk, intermediate risk and high risk as per EAU guidelines.
Results: Sixty patients were enrolled in the study. Mean age of the patients is 62.75 years with male: female ratio 20:1. 46.6% of patients had intermediate and 53.4% had high risk disease. Mean follow-up period in the study was 32.27 weeks. 93.4% of patients had grade 1 symptoms and 6.6% had grade 2 symptoms. None of the patients had grade 3 serious complications.
Conclusions: Intravesical OncoBCG (Moscow strain) is safe and well tolerated in study population
A study on the prevalence of risk factors associated with non-steroidal anti-inflammatory drugs-induced adverse effects among inpatients at a tertiary care hospital
Get PDFBackground: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for pain relief and as antipyretics in day-to-day life. However, their adverse effects can be intensified in the presence of certain risk factors. This study aims to identify the risk factors associated with NSAID-induced adverse effects. It also serves to support clinical pharmacists in minimizing these risks and enhancing patient safety.
Methods: Data from a total of 175 inpatients were collected prospectively using a structured data collection form based on defined inclusion and exclusion criteria. The study was conducted over a period of six months. The WHO-UMC causality assessment scale was used to evaluate adverse drug reactions (ADRs), and Hartwig’s severity assessment scale was used to determine the severity. SPSS software was employed for analysing the categorized data.
Results: Among 175 patients receiving NSAID therapy, the most prevalent risk factor identified was polypharmacy (64%), followed by older age (38%). Preventive co-therapies, such as proton pump inhibitors (PPIs), were administered in 81.1% of cases. The study also reported a specific ADR generalized pruritus induced by diclofenac, which was assessed as probable on the WHO-UMC causality scale and mild (Level 2) on Hartwig’s severity scale.
Conclusions: The study concludes that all NSAID prescriptions were rational and appropriate. Identifying risk factors and prescribing preventive co-therapies during NSAID treatment contributes to improved patient care and therapeutic outcomes
Cost-variation analysis between different brands of cardiovascular drugs available in the Indian market
Get PDFBackground: Cardiovascular diseases (CVDs) emerging as a leading cause of mortality in India, access to affordable medications is crucial for managing these conditions. Our study examined the significant cost variations among different brands of cardiovascular drugs available in the Indian market. The study was conducted to find out the cost variation in the cardiovascular drugs available in India and to evaluate the difference in cost of various brands of the same by calculating percentage of variation in cost.
Methods: The analytical study was carried out by taking the cost of a particular drug in the same dosage forms and strength being manufactured by different companies was obtained from July-October 2024 edition of the current index of medical specialities (CIMS) and July-October 2024 edition of monthly index of medical specialties (MIMS) and percentage cost variation was calculated.
Results: Our analysis revealed a wide price variation among various drug brands of cardiovascular drugs. Furosemide 40 mg tablet has shown the highest price variation (1572.86%), while least price variation is seen in hydrochlorothiazide 25 mg tablet (3.98%).
Conclusions: Prices of various drugs used in the treatment of cardiovascular drugs show a wide variation in the Indian market. Medication adherence, community health, and the financial burden of healthcare costs on the country would all be improved by lowering price variation and making drugs more affordable. The findings highlight the urgency of implementing measures to reduce price variations and improve affordability, thereby enhancing healthcare access and mitigating the financial burden on individuals and society. However, it’s important to note the study’s limitations, including the selection of only a subset of drug brands available in CIMS and MIMS for analysis
In vitro assessment of ceftazidime-avibactam combined with aztreonam for mitigating antimicrobial resistance in clinical isolates of multidrug-resistant Gram-negative bacilli
Get PDFBackground: Antimicrobial resistance (AMR) represents a major global public health threat, with increasing MDR infections caused by Gram-negative such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter spp. The limited antibiotic pipeline and ineffective treatments have necessitated the development of novel drug combinations. Among these, the combination of ceftazidime-avibactam with aztreonam has shown promise, particularly against serine-β-lactamase and metallo-β-lactamase producing strains that are resistant to conventional therapeutics.
Methods: Identification of isolates was done by routine biochemical testing; AST was determined by Kirby-Bauer disc diffusion, interpreted by CLSI guidelines. MDR, XDR, PDR were characterized. ESBL producers and carbapenem resistant strains were detected phenotypically using CLSI guidelines. In vitro synergy of ceftazidime-avibactam plus aztreonam was assessed by broth disc elution, following CLSI recommendations.
Results: Of 183 isolates of gram-negative bacilli, Escherichia coli (n=67), Klebsiella pneumoniae (n=72), Pseudomonas aeruginosa (n=29) and Acinetobacter spp. (n=15) in which MDR 68.65% was reported in Escherichia coli and 66.66% of XDR was reported in Klebsiella pneumoniae. ESBL was detected in 68 of 80 Enterobacterales, while 90 of 150 tested GNB were carbapenem resistant; Klebsiella pneumoniae contributed highest numbers. The combination of ceftazidime-avibactam with aztreonam yielded synergistic activity in 83.4% of all GNB isolates. Within carbapenem-resistant Enterobacterales, susceptibility to the combination was 97.2%, contrasting with only 15.7% susceptibility among carbapenem-resistant non-fermenters. Resistance to the combination was especially high among XDR and PDR Acinetobacter spp. and Pseudomonas aeruginosa.
Conclusions: The combination of ceftazidime-avibactam with aztreonam demonstrates strong in vitro synergy and enhanced susceptibility against MDR and carbapenemase-producing Enterobacterales especially Klebsiella pneumoniae suggesting clinical promise where conventional drugs fail. However, limited efficacy was observed against non-fermenter groups, underscoring the need for continuing resistance surveillance and further therapeutic innovation in multidrug-resistant non-fermenters
Cefepime-Enmetazobactam: a novel β-Lactam/β-Lactamase inhibitor combination for complicated urinary tract infections
Get PDFComplicated urinary tract infections (cUTIs) represent a significant global health challenge, particularly with the rising prevalence of extended-spectrum β-lactamase (ESBL)-producing pathogens. Cefepime-Enmetazobactam, approved in India in June 2024, represents a novel β-lactam/β-lactamase inhibitor combination specifically developed to address multidrug-resistant Gram-negative infections. This review examines the pharmacological properties, clinical efficacy, and therapeutic potential of Cefepime-Enmetazobactam in managing cUTIs. The Phase 3 ALLIUM trial demonstrated superior clinical cure and microbiological eradication rates compared to Piperacillin-Tazobactam, with particularly pronounced efficacy against ESBL-producing Enterobacterales (73.7% vs 51.5%). The combination exhibits a favourable safety profile with transaminase elevation, increased bilirubin, headache, and infusion site reactions being the most common adverse events. As a carbapenem-sparing option, Cefepime-Enmetazobactam addresses critical antimicrobial stewardship concerns while providing an effective treatment alternative for resistant pathogens. While demonstrating promising results, further research regarding long-term outcomes, resistance development, and cost-effectiveness is warranted to fully establish its role in contemporary antimicrobial therapy
Evaluation of brand, ceiling and generic price differences in anti-epileptic drugs marketed in India: a novel cost variation analysis
Get PDFBackground: Epilepsy affects 6–10 million people in India, where over 60% of healthcare spending is out-of-pocket. Wide price differences in branded antiepileptic drugs (AEDs) can hinder adherence and increase financial burden. While DPCO sets ceiling prices and Jan Aushadhi offers low-cost generics, no Indian study has compared AED prices across both schemes. To assess price variation among 17 commonly used AEDs and compare brand prices with DPCO ceilings and Jan Aushadhi rates.
Methods: A cross-sectional cost analysis was conducted using MRPs from the Current Index of Medical Specialties, NPPA database and Jan Aushadhi Scheme database. Price variation and ratios were calculated. Median brand prices were benchmarked against DPCO and JAS prices to evaluate cost gaps.
Results: Pregabalin 75 mg capsules showed the highest inter-brand cost variation (564.7%), followed by pregabalin 150 mg tablets (487.9%) and levetiracetam 750 mg tablets (370.4%). Phenytoin 300 mg ER tablets were priced 39.63% above the DPCO ceiling and sodium valproate 200 mg tablets exceeded it by 36.7%. Branded AEDs were 0.7 to 8 times costlier than Jan Aushadhi generics; pregabalin 75 mg capsules were 667.73% more expensive.
Conclusions: This first dual-layered analysis of AED pricing in India shows wide price variation and poor compliance with controls. Expanding DPCO coverage, promoting generics and educating prescribers on drug costs can improve affordability and adherence