Background: Fungal infections are the 4th most common skin disease affecting 984 million people. Fungal infections are mostly associated with the use of broad-spectrum antibiotics, corticosteroids, anticancer/immunosuppressant drugs, indwelling catheters and implants, and the emergence of AIDS. The aim of this study was to analyze the rational use, cost ratio, and percentage cost variations in different brands of the commonly prescribed antifungal drugs available in the Indian market.Method: The maximum and minimum price of each brand of the drugs given in Indian rupees (INR) was noted by using ‘Drug Today’ (January to April 2021, volume II). The cost range, cost ratio, and the percentage cost variation for individual drug brands were calculated. The cost of tablets/capsule/injection was calculated and the cost ratio and percentage cost variation of various brands was compared.Results: After calculation of cost ratio and percentage cost variation for each brand of antifungal agents, tab Itraconazole 100 mg had a maximum percentage cost variation of 733.33% and a cost ratio of 8.33 while tab Griseofulvin 250 mg had a minimum percentage cost variation of 16.98% and cost ratio of 1.16.Conclusions: The present study shows there was a wide variation in the cost of the different brands of antifungal drugs manufactured by pharmaceutical companies which increases the economic burden. The clinicians prescribing these drugs should be aware of rational use and cost variation to reduce cost of drug therapy and improve patient compliance.
Background: Cutaneous drug reactions are most frequent drug related adverse events which lead to early treatment discontinuations, high treatment cost and leading cause of morbidity and mortality. The aim of this study is to analyze the clinical patterns and offending drugs as well as their causality, severity and preventive strategies.Methods: All adverse drug reactions (ADRs) forms filled from May 2015 to April 2016 were scrutinized and forms with cutaneous drug reactions were analyzed and assessed for causality, severity and preventability.Results: Out of 300 ADR forms, 160 (53.34%) included cutaneous drug reactions. 68 (42.50%) patients were male and 92 (57.50%) were female. Maculopapular rash 58 (36.25%), fixed drug eruption (FDE) 31 (19.37), pruritus 27 (16.87%) and urticaria 19 (11.87%) were the common clinical patterns of cutaneous drug reactions. Most common offending drug classes included antibiotics, anti-inflammatory and steroidal agents. Causality assessment was done by using Naranjo’s algorithm. The result showed that out of 160 cutaneous drug reactions 141 (88.12%) ADRs were probable, 15 (9.37%) were classified as possible; 2 (1.25) doubtful and 2 (1.25%) were definitely related to the drug.Conclusions: The present study shows cutaneous drug reactions are commonly reported at ADR monitoring centre of this tertiary care hospital. Our study suggests that there is a need of intensive monitoring for ADRs in tertiary care hospital for early detection and to ensure the patient safety.
The pharmacovigilance program of India (PvPI), after its inception, has been reliably acquiring force in bringing issues to light among the masses, healthcare professionals, the pharma industry, and clinical staff at hospitals. Adverse drug reactions are unintended events that occur after exposure to a drug, biological product, or medical device, and they may result in morbidity and mortality. It is critical to monitor the safety of drugs during the post-marketing phase to find long-term and rare ADRs, as well as ADRs in special populations and patients with co-morbidities that are not usually included during clinical trials. The definitive objective of pharmacovigilance is to collate data and analyze it. Assessing the causality between ADRs and drugs is necessary to decrease the occurrence of ADRs and to reduce the risk of drug-related ADRs. ADRs may lead to increased morbidity, increased hospital stays, and increased cost of treatment, resulting in compromised patient safety. Causality assessment is the evaluation of the likelihood that a particular treatment is the cause of an observed adverse event and establishing a causal association between a drug and a drug reaction is necessary to prevent further recurrences. Numerous methods available for establishing a causal association between the drug and adverse events have been broadly classified into clinical judgment or global introspection, algorithms, and probabilistic methods. These include the Swedish method, World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, Naranjo's algorithm, Kramer algorithm, Jones algorithm, Karch algorithm, Bégaud algorithm, Adverse Drug Reactions Advisory Committee guidelines, Bayesian Adverse Reaction Diagnostic Instrument, and so on. Despite various methods available, none of the causality assessment tools have been universally accepted as the gold standard. Naranjo's algorithm and WHO-UMC scales are, however, the most commonly used. Similarly, for preventability and severity assessment of ADRs, the Schumock and Thornton scale and Hartwig and Siegel's scale are most commonly used. Hence, we reviewed different tools and methods available to assess the causality, preventability, and severity of ADRs.
Background: A cardiovascular disease (CVD) is one of the most common causes of mortality and morbidity globally. The drastic change in the lifestyle of population during 21st century has had a great impact on health especially cardiovascular diseases. Objective of this study was to assess the prescription pattern of fixed dose drug combinations (FDCs) in the department of cardiology in a tertiary care hospital.Methods: The prescriptions of 210 patients suffered by cardiovascular disorders who attended the department of cardiology were analysed and following data were collected - patient demographics, diagnosis, dosage form, therapeutic category, cost of FDCs compared to individual drugs, duration of therapy, the total number of drugs per prescription and FDCs prescribed, composition of the FDC, whether FDC prescribed is approved by WHO list of essential medicine. A descriptive analysis of data was done.Results: 15 types of FDCs prescribed were received by 92(43.80%) individuals among 210 patients who attended the cardiology OPD. Prescription of FDCs was most common 28 (30.43%) in patients age group 51-60 years. The commonly prescribed FDC was aspirin with atorvastatin followed by telmisartan with hydrochlorothiazide.Conclusions: The results suggested that FDCs for cardiovascular disorders are frequently prescribed by cardiologist. However all are not approved by WHO list of essential medicine. This study was focused on rational use of FDCs for prescribers for cardiovascular morbidities and mortality.
Background: Main objective of this study was to find out the students’ perception and to obtain feedback towards the use of Animal Simulator to demonstrate drug effects in terms of its acceptability, advantages and disadvantages of Computer Assisted Learning (CAL) in experimental pharmacology practical as an educational tool.Methods: Questionnaire based study, done on randomly and voluntarily selected ninety-six fourth and fifth semester MBBS Students. Divided into four groups and each group contained 24 students. Students were taught experimental pharmacology practical online using Animal simulator (CAL- Computer Assisted Learning) for 2 hours on different days in three sessions. Questions and their feedback was taken during these sessions and presented in tables. Statistical analysis of data was done using Graph Pad software.Results: Majority of students i.e. 64 (66.67%) agreed that in vitro and in vivo experiments on animals are essential for better understanding and learning of the biological process. Students were agreed to the majority of the statements for CAL like enjoyable and time saving, easy to perform, contributes more to understanding theoretical concepts, no experimental error seen, welcome change and best alternative to laboratory practical and many experiments can be demonstrated in a short time. Students were disagreed on statements like CAL is an effective method of teaching practical aspects and preferred experimentation than laboratory practical. Majority of students given yes/positive response to questions showing advantages of using CAL. Also, positive feedback was obtained regarding questions showing disadvantages of using CAL software.Conclusions: Students’ perception regarding practical with CAL laboratory using animal simulator was good. The overall view was expressed that they found the exercises interesting and educationally beneficial. Computer assisted learning is a feasible and very effective teaching and learning method in pharmacology with huge potential to change the way of learning as it meets the majority of the learning objectives.
Introduction: Package insert (PI) is the printed leaflet available with the medicines containing information about the drug based on regulatory guidelines for its safe and effective use. Information in a PI is incorporated since the developmental phase of a pharmaceutical product with careful scrutiny of available information. PI contains evidenced based information about a drug, updated from time to time as soon as relevant preclinical and clinical data were obtained. Various studies had shown poor compliance 50-60% to the medicine prescribed for the treatment of chronic conditions like hypertension, diabetes and dyslipidemia. These diseases proved to be major cause of mortality and morbidity related to cardiovascular diseases in India. The information of the PI has an important impact on patients compliance and hence effectiveness of the drug used and for health professionals they can serve as reliable and accurate sources of drug information. Material & Methods: Present study was observational and Prospective with study duration of 1 month. 93 package inserts were collected from different pharmacies of the Patna on request. Analysis of content of Package Insert was based on criteria laid down by Indian Drug and Cosmetic Rules, 1945 under section 6.2 of schedule D. Result: A total number of 106 PI were received, among which 93 PIs were analysed for the result remaining 13 PIs were discarded due to duplicity and unauthenticity. Out of them, 87 were from Indian pharmaceutical companies and 6 from multinational companies [Graph-2]. All PIs of antihypertensives and hypolipedemic were of oral preparations. Out of 93 PIs 37 were antihypertensives, 34 were antidiabetics and 22 hypolipidemics. Out of 34 anti-diabetic PIs, 22 (59.6%) were oral and 12 (40.4%) were injectable preparations. Out of 93 PIs, 40 (43%) belonged to Grade A (including all injectable preparations) and remaining 53 (57%) to Grade B. No PIs belongs to Grade C.87 PIs were from Indian companies and 6 PIs were from multinational companies. It was observed that more PIs from Indian companies belonged to Grade A. Conclusion : we are facing the pandemic of diseases like hypertension, diabetes mellitus and other diseases. In such situation PI can play a vital role in improving the patient compliance and thereby the prognosis of disease. Hence a smart PI which is complete, reliable and up-to-date is the need of the hour.
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