International Journal of Basic & Clinical Pharmacology
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Ischemic priapism induced by a fixed drug combination of tamsulosin and tadalafil
Priapism, a persistent erection lasting more than 4 hours, can be caused by various factors, including medications. This case report presents a 23-year-old male who developed ischemic priapism after taking tablet Contiflo-T, a combination of tamsulosin and tadalafil. The patient required multiple interventions, including aspiration and intracavernosal phenylephrine injections, to resolve the condition. The combination of these drugs, which are commonly used for urinary tract symptoms and erectile dysfunction, likely contributed to the priapism by increasing blood flow to the penis and preventing its return to a flaccid state. This case highlights the potential for adverse drug interactions and the importance of careful monitoring when prescribing medications for these conditions
Evaluation of adverse drug reactions in a tertiary care hospital in India
Background: Adverse drug reaction (ADR) is a major concern in the healthcare system and has been a persistent issue in the health sector. This study aimed to evaluate and assess the ADRs reported, the system organ class (SOC) affected, seriousness, outcomes, causality.
Methods: A retrospective observational study in a tertiary care hospital from April 2021 to May 2024. A descriptive analysis of reactions, causality of suspected drugs was carried out according to the setting analysed.
Results: Out of 7,396 individual case safety report (ICSR) reported, the highest number of ADRS was reported in the age group of 18-65 years (57.8%) and male patients (51.1%). Using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale, 67.1% events were possible. A significant majority of drug reported as ‘certain’ were of anti-infective class (51.03%). Most frequently affected SOC was blood and lymphatic system disorders (15.9%), Of all events, greater part of the reactions was non-serious (95.3%), the most drugs causing ADRs was anti neoplastic and immunodulating agents (40.4%) and 47.2% of drugs were high alert medications. The greater part of ADRs reporting was carried out by clinical pharmacists (95.9%).
Conclusions: The results highlighted the importance of clinical pharmacist in monitoring and spontaneous reporting of ADRs. Awareness and educational programs may help in active reporting among all healthcare providers
A prospective study on optimizing arrhythmia management in a tertiary care hospital
Background: Arrhythmias, particularly atrial fibrillation (AF), significantly contribute to morbidity and mortality, especially in older adults. Effective management is essential to reducing stroke risk and improving outcomes. However, real-world treatment often deviates from guidelines, raising concerns about care consistency. This study aims to identify prevalent arrhythmias, assess stroke risk, examine the relationship between arrhythmias and age, and analyze prescription patterns of antiarrhythmic drugs (AADs) and anticoagulants in a tertiary care setting.
Methods: A prospective observational study was conducted with 50 patients diagnosed with arrhythmias. Data were collected through structured interviews using the arrhythmia-specific questionnaire in tachycardia and arrhythmia (ASTA) and medical records. Prescription patterns were analyzed using the Vaughan-Williams classification system.
Results: Atrial fibrillation with a rapid ventricular rate (AF with FVR) was the most common arrhythmia (44%). A significant 88% of patients had a severe stroke risk based on the CHAD₂ scale. Beta-blockers were the most prescribed AADs (45.59%), with amiodarone being the most common (30.88%). Heparin (37.68%) and aspirin (28.99%) were the leading anticoagulants.
Conclusions: The findings highlight AF’s high prevalence and associated stroke risk in older adults. While prescription patterns align with guidelines, the reliance on Amiodarone necessitates careful monitoring. Greater adherence to guideline-recommended newer oral anticoagulants (NOACs) is needed to optimize outcomes
Is intervening inflammatory pathways a way to treat type 2-diabetes
Over the past few decades, the prevalence of type 2 diabetes (T2D) has rapidly increased. Cardiovascular kidney-metabolic (CKM) syndrome commonly arises from excessive or defective adipose tissue or combination of both. Proinflammatory mediators secreted by dysfunctional adipose tissue, especially visceral adipose tissue damage kidney, heart and artery tissues. Excessive storage of fatty acids disrupts the endocrine functions of adipose tissue, resulting in ectopic fat accumulation that induces lipotoxicity, thereby promoting low-grade inflammation and insulin resistance (IR) in the liver. Systemic inflammation and IR are exacerbated by the onset of metabolic dysfunction-associated steatotic liver disease, formerly known as non-alcoholic fatty liver disease (NAFLD). It is well established that low grade inflammation plays an important role in T2D and its associated microvascular complications like nephropathy, neuropathy, retinopathy and macrovascular complications like atherosclerosis. Accelerated atherosclerosis predisposes to cardiovascular diseases, which is the leading cause of mortality in these patients. Till date, various anti-inflammatory drugs have been tried in the setting of chronic disorders such as T2D and CVD (cardiovascular diseases). But too selective targeting may not have produced the desired outcomes. Multiple inflammatory pathways contribute to the pathogenesis of CVD and T2D, hydroxychloroquine (HCQ), a broad anti-inflammatory agent, demonstrates beneficial effects on glucose and lipid metabolism and is the only DCGI approved anti-inflammatory drug for T2D. Due to pleotropic benefits, HCQ has the potential of reducing prediabetes for diabetics, has antidiabetic properties and also reduces complications of diabetes, most importantly, CVD associated with T2D
A study of awareness of generic drugs amongst residents and intern doctors in a tertiary care hospital in Surat city
Background: As defined by WHO generic drug is “a pharmaceutical product which is intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights”. They are made with the same active substance as the non-generic drugs which are already authorized and approved for their safety, efficacy and quality before getting licensed.
Methods: A cross-sectional, prospective, questionnaire-based study was conducted on 115 residents and intern doctors. Awareness and knowledge about generic drugs were checked using pre-validated questionnaire which was followed by an educational intervention and post-questionnaire. The collected data was analysed using MS-excel.
Results: The 94 participants voluntarily responded. As per the result of pre-test many participants were not aware of the difference between generic and branded drug, but after conducting educational intervention, increase in knowledge about generic drugs, branded drugs, safety, efficacy, availability and regulation regarding prescription of generic drug was seen. In post-test, 98.94% believed that generic drugs are cheaper than branded drugs and 95.74% agreed that generic drugs are as safe as branded drugs, while 97.87% believed increasing awareness regarding generic drugs will increase acceptability of generic drugs.
Conclusions: The reasons for opting branded drugs were lack of awareness regarding efficacy, safety, acceptability and availability of generic drugs. Periodic training program would help in clearing doubts, enhance the prescribing of generic drugs and reduce the health expenditure and economic burden
A prospective cross-sectional study of knowledge, attitude, and perception on the mechanism of action of drugs among 3rd year MBBS students at Kurnool Medical College
Background: Recent times have witnessed the emergence of many new drugs and drug combinations due to the technological advances targeting personalized therapeutics. Proper knowledge and understanding on mechanism of action of prescribing drugs is essential to avoid complications like drug-drug interactions, adverse drug effects, antimicrobial resistance, treatment failure and financial burden on the patient and nation as well. It is the need of the hour to impart adequate knowledge to the medical undergraduates on mechanism of action of drug.
Methods: A prospective, cross sectional, observational study was carried out to assess the knowledge, attitude and perception (KAP) on mechanism of action of drug among 3rd MBBS students, Kurnool Medical college, Kurnool. A pre-validated questionnaire was used to assess the KAP using Google forms.
Results: A total of 240 google forms were analyzed. According to Bloom’s taxonomy, the mechanism of action of Aspirin and Statins was correctly known to 92.9% and 80.8% of students, respectively. The use of albuterol in the treatment of asthma and use of proton pump inhibitor in the treatment of gastroesophageal reflux disease were known to 65.0% and 76.7% of students respectively. 25.4% students only know the mechanism of action of metformin. 68.8% of the students strongly believe that the mechanism of action of drug is very important to prescribe drugs by the physicians. 45.8% of students strongly agreed that good understanding of mechanism of action of drug would help in future practice for better patient outcomes.
Conclusions: It is essential to revise and have peer group discussions periodically to memorize and update themselves about the mechanism of action of both the established and new drugs. Various teaching methods like small group discussions, self-directed learning (SDL), integrating teaching, OSPE (Objective Structured Practical Examination) and role play can be utilized effectively to make learning interesting, interactive and more productive
Evaluation of antibiotic utilization pattern in indoor patients of obstetrics and gynaecology in a tertiary care hospital of central India
Background: Understanding prescribing patterns is vital to address irrational antibiotic use, a key contributor to antimicrobial resistance. The aim of the study was to evaluate antibiotic prescription practices among hospitalized patients and examine the presence of an antibiotic stewardship program in a tertiary care hospital. The findings may aid in developing stewardship initiatives to promote rational antibiotic use.
Methods: A prospective observational study was conducted from March 1 to August 30, 2024, at Government Medical College and Hospital, Gondia, Maharashtra. Data were collected using WHO prescribing drug indicators and analysed using SPSS Version 25.
Results: The mean difference in final and initial serum creatinine values were observed to be 0.32 and 0.52 with a standard deviation of 0.228 and 0.387 in AM and GM group respectively. This difference was statistically significant with p value of 0.007. The mean difference in final and initial creatinine clearance values were observed to be 18.82 and 24.76 with a standard deviation of 10.14 and 11.93 in AM and GM group respectively. This difference was also statistically significant with p value of 0.013. Nephrotoxicity occurred in 9 out of 50 patients (18%) in AM group out of which 12% were male and 6% were female whereas in case of GM group nephrotoxicity occurred in 16 out of 50 patients (32%) in which 26% were male and 6% were female.
Conclusions: Prescribing patterns deviated from WHO indicators, with high empirical use. Strengthening antimicrobial stewardship and increasing microbiological testing are essential to improve antibiotic practices
Evolving therapeutics in acid-related disorders of the gut: is vonoprazan the drug of the next decade
Vonoprazan a competitive potassium acid blocker (P-CAB) has been gaining traction compared to the use of traditional PPIs for the treatment of GERD and other acid-related disorders. We aim to review its comparative edge over the other widely used PPIs and its combination therapies in this article. It is also emerging to show superiority in mucosal and clinical healing rates in the already published literature. The mechanism of action of vonoprazan involves the antagonism of potassium channels present in parietal cells, thereby inhibiting gastric acid secretion. This distinctive mode of action effectively suppresses acid secretion in gastroesophageal reflux disease (GERD) and erosive esophagitis. For clinical usage, 20 mg of vonoprazan has been reported to be more effective in the management of acid-related disorders compared to conventional PPIs. This article underscores the need for continued research to fully elucidate the potential of vonoprazan in managing acid-related disorders, particularly in populations beyond Japan where its utility remains to be fully explored. It also aims to enlighten healthcare providers regarding its usage in the management of acid-related gastrointestinal disorders by providing insights into its clinical utility, practical considerations, & effective drug combinations eventually ameliorating patient outcomes and quality of life
Assessment of pattern of adverse drug reactions with chemo-therapeutic drugs in a tertiary care hospital of Government Medical College Anantnag: a prospective observational study
Background: Adverse drug reactions (ADRs) are a global problem. The high toxicity of chemo-therapeutic agents makes assessment of ADR's due to anti-cancer drugs essential. The present study is done with the aim to assess and evaluate the pattern of ADR's due to anti-cancer therapy in hospitalized patients and to analyse the causality and severity of these reactions.
Methods: A prospective observational study was conducted in department of pharmacology after getting approval from institutional ethics committee, GMC Anantnag over a period of 1 year. Patients of either sex with age >18 years was included. Data was collected directly from admitted patients in the oncology department and also from their medical case files. Causality and severity of ADRs were assessed by using the WHO-UMC causality scale and modified Hartwig and Seigel severity scale, respectively.
Results: A total of 982 ADRs were reported from 442 patients. Mean age of all patients was 37.49±11.88 years with 260 (58.82%) females and 182 (41.17%) males. Colorectal carcinoma (18.55%) was found to be the most common. Among 442 patients included in this study, 982 ADRs were recorded, with the most common being nausea/vomiting (n=166, 16.90%) followed by alopecia (n=142, 14.46%) and skin rashes (n=121, 12.32%). On causality assessment, as per WHO-UMC criteria 85.78% of the reactions were probable and 8.26% were possible. The severity of the reported reactions based on modified Hartwig and Siegel scale showed 742 (75.56%) ADRs to be mild, 227 (23.1%) ADRs to be moderate and 13 (1.32) to be severe.
Conclusions: ADRs are most important causes of morbidity and mortality and increase the economic burden on patient and society. Management of ADRs beforehand will help in reducing the suffering of patients and increase compliance. ADR monitoring is the need of the hour especially in cancer patients in order to increase quality of life, and decrease morbidity and mortality. However, early detection of the ADRs may help to modify the doses or the drug regimen to minimize the adverse effects
Anti-plasmodial activity of artemether-lumefantrine-tinidazole on plasmodium falciparum infected humans
Background: The emergence of multi-drug resistant strains of Plasmodium falciparum has intensified the search for effective compounds. This study aimed to evaluates the combined effects of tinidazole and artemether/lumefantrine on human participants infected with P. falciparum.
Methods: The study involved 25 non-infected adults as controls and 75 infected adults, divided into three groups of 25. The groups were treated orally with 1g of Tinidazole (T) twice daily for 3 days, an 8-hourly initial dose followed by 12-hourly 80mg/480mg doses of Artemether/Lumefantrine (AL) for 3 days, and a combination of 1g tinidazole and artemether/lumefantrine (80mg/480mg) for 3 days. Venous blood samples were taken on days 0, 4, and 14 to evaluate renal function, parasitemia, hematological parameters, lipid profiles, and antioxidant measures (catalase, SOD, glutathione peroxidase, and malondialdehyde).
Results: The percentage recovery with AL, T, and the combination of T and AL was 88%, 92%, and 100%, respectively. Malaria patients exhibited significantly lower levels of red blood cells, hemoglobin, packed cell volume, low-density lipoprotein, high-density lipoprotein, total cholesterol, catalase, superoxide dismutase, and glutathione peroxidase, and higher levels of white blood cells, triglycerides, and malondialdehyde compared to the control group. Post-treatment, there was a modest reversal on day 4 and a significant return to normal ranges by day 14. Malaria infection did not affect urea or creatinine levels.
Conclusions: Tinidazole shows potential as a treatment for P. falciparum, with enhanced efficacy when combined with artemether/lumefantrine