Evaluation of knowledge, attitude and practice about research ethics and research ethics committee among post graduate residents in a tertiary care hospital in Pune, Maharashtra, India

Background: A research ethics committee (REC) is a body responsible for ensuring that medical experimentation and human research are carried out in an ethical manner in accordance with national and international law. It is mandatory that all the research projects should be approved by EC before commencement. Recently Medical council of India has introduced mandatory online research methodology module consisting of assignments followed by mandatory exam.Methods: A cross-sectional study using a self-administered, validated questionnaire was administered among PG residents of a tertiary care hospital in Pune having a functional ethics committee was conducted for 3 months. Number of correct and incorrect responses were noted and calculated in percentage.Results: Total of 125 residents were enrolled and 119 subjects responded. The response rate was 95.2%. The respondents included 59.66% clinical and 40.33% nonclinical post graduate residents. 87.39% knew the role of IEC. 95.79% said informed consent should be mandatory document. 98.31% were aware about the institutional ethics committee (IEC) in the institution. 84.87% think EC and research ethics should be taught as a mandatory PG module.Conclusions: Authors conclude that among the clinical and non-clinical postgraduates participating in study, there is acceptance of IECs and training in research ethics, while there are knowledge gaps in research ethics guidelines and composition of IEC. The updated MCI curriculum imbibes research curriculum but should focus on details about ethics in biomedical research. It can be initiated by workshop/awareness programmes compulsory for UG and PG students

Cost variation analysis of commonly prescribed anti-diabetic drugs available in Indian market: a pharmaco-economic study

Background: Diabetes mellitus (DM) is a chronic metabolic disorder requiring lifelong treatment. Due to rapid expansion of urbanization, unhealthy diet habits and sedentary lifestyle, the incidence of DM is increasing. The chronic nature of DM causes significant personal suffering and economic difficulty to families. The was aimed at investigating the cost difference in various brands of the same oral anti-diabetic drug.Methods: The minimum and the maximum cost in rupees (INR) of a particular anti-diabetic drug manufactured by various pharmaceutical companies were obtained from current index of medical specialties (CIMS) website, Indian drug review (IDR) 2021 issue and National pharmaceutical pricing authority-pharma sahi daam. The cost ratio and percentage cost variation were noted for each brand.Results: Amongst single drug therapy, metformin 500 mg sustained release showed highest price variation (3668%). Minimum cost variation was found with glipizide 2.5 mg (65%). Amongst the fixed dose combinations, highest cost variation was seen with glimepiride 2 mg+metformin 1000 mg (2703%) while minimum cost variation was found with repaglinide 1 mg+voglibose 0.3 mg (29%).Conclusions: A noticeable cost variation was found in different brands of the same anti-diabetic drug. Prescribing a more expensive brand when a cheaper one is available can burden the patient financially and thus reduce patient compliance. In addition, the Government should also include more anti-diabetic drugs under the price control policy to ensure that affordable and efficacious medicines are available to all.Background:  Diabetes mellitus (DM) is a chronic metabolic disorder requiring lifelong treatment. Due to rapid expansion of urbanization, unhealthy diet habits and sedentary life style, the incidence of DM is increasing .The chronic nature of DM causes significant personal suffering and economic difficulty to families. The present study aims at investigating the cost difference in various brands of the same oral anti-diabetic drug.Methods: The minimum and the maximum cost in rupees (INR) of a particular anti-diabetic drug manufactured by various brands were obtained from Current Index of Medical Specialties (CIMS) website, Indian Drug Review (IDR) 2021 issue and National Pharmaceutical Pricing Authority – Pharma sahi daam. The cost ratio and percentage cost variation were noted for each brand.Results: Amongst single drug therapy, Metformin 500mg Sustained Release showed highest price variation (3668%). Minimum cost variation was found with Glipizide 2.5mg (65%).Amongst the fixed dose combinations, highest cost variation was seen with Glimepiride 2mg + Metformin 1000mg (2703%) while minimum cost variation was found with Repaglinide 1mg + Voglibose 0.3mg (29%). Conclusions: A noticeable cost variation was found in different brands of the same anti-diabetic drug. Prescribing a more expensive brand when a cheaper one is available can burden the patient financially and thus reduce patient compliance. In addition, the Government should also include more anti-diabetic drugs under the price control policy to ensure that affordable and efficacious medicines are available to all. Keywords: Anti-diabetic agents, Cost variation, Pharmaco-economics, Adherence, Brands   Background:  Diabetes mellitus (DM) is a chronic metabolic disorder requiring lifelong treatment. Due to rapid expansion of urbanization, unhealthy diet habits and sedentary life style, the incidence of DM is increasing .The chronic nature of DM causes significant personal suffering and economic difficulty to families. The present study aims at investigating the cost difference in various brands of the same oral anti-diabetic drug.Methods: The minimum and the maximum cost in rupees (INR) of a particular anti-diabetic drug manufactured by various brands were obtained from Current Index of Medical Specialties (CIMS) website, Indian Drug Review (IDR) 2021 issue and National Pharmaceutical Pricing Authority – Pharma sahi daam. The cost ratio and percentage cost variation were noted for each brand.Results: Amongst single drug therapy, Metformin 500mg Sustained Release showed highest price variation (3668%). Minimum cost variation was found with Glipizide 2.5mg (65%).Amongst the fixed dose combinations, highest cost variation was seen with Glimepiride 2mg + Metformin 1000mg (2703%) while minimum cost variation was found with Repaglinide 1mg + Voglibose 0.3mg (29%). Conclusions: A noticeable cost variation was found in different brands of the same anti-diabetic drug. Prescribing a more expensive brand when a cheaper one is available can burden the patient financially and thus reduce patient compliance. In addition, the Government should also include more anti-diabetic drugs under the price control policy to ensure that affordable and efficacious medicines are available to all. Keywords: Anti-diabetic agents, Cost variation, Pharmaco-economics, Adherence, Brands   Background:  Diabetes mellitus (DM) is a chronic metabolic disorder requiring lifelong treatment. Due to rapid expansion of urbanization, unhealthy diet habits and sedentary life style, the incidence of DM is increasing .The chronic nature of DM causes significant personal suffering and economic difficulty to families. The present study aims at investigating the cost difference in various brands of the same oral anti-diabetic drug.Methods: The minimum and the maximum cost in rupees (INR) of a particular anti-diabetic drug manufactured by various brands were obtained from Current Index of Medical Specialties (CIMS) website, Indian Drug Review (IDR) 2021 issue and National Pharmaceutical Pricing Authority – Pharma sahi daam. The cost ratio and percentage cost variation were noted for each brand.Results: Amongst single drug therapy, Metformin 500mg Sustained Release showed highest price variation (3668%). Minimum cost variation was found with Glipizide 2.5mg (65%).Amongst the fixed dose combinations, highest cost variation was seen with Glimepiride 2mg + Metformin 1000mg (2703%) while minimum cost variation was found with Repaglinide 1mg + Voglibose 0.3mg (29%). Conclusions: A noticeable cost variation was found in different brands of the same anti-diabetic drug. Prescribing a more expensive brand when a cheaper one is available can burden the patient financially and thus reduce patient compliance. In addition, the Government should also include more anti-diabetic drugs under the price control policy to ensure that affordable and efficacious medicines are available to all. Keywords: Anti-diabetic agents, Cost variation, Pharmaco-economics, Adherence, Brands        

A pharmacoeconomic study of different brands of commonly prescribed antihypertensive drugs

Background: The hypertension is the most common chronic disease, therefore treatment should be affordable. The antihypertensive drugs of same strength are available in market at different costs. This study was undertaken to create awareness among health care workers and patients, about cost difference among different brands of same antihypertensive drug. So that whenever possible, a cheaper effective brand can be prescribed to ensure better patient adherence.Methods: Maximum retail price (MRP) of various antihypertensive drugs of same strength, manufactured by different pharmaceutical companies was obtained from various offline and online sources. The minimum and maximum cost of 10 tablets/capsules noted. The cost ratio and percentage cost variation was calculated for single drug and fixed dose combinations. The ceiling price (as per DPCO) of essential antihypertensives (as per national list of essential medicines) was compared with their maximum cost.Results: The formulations of single antihypertensive drugs (41) and fixed dose combinations of two drugs (19) and three drugs (9) were included in the study. Among the single antihypertensives analyzed the highest cost difference was of eplerenone (50 mg) and high cost ratio and cost variation percentage was of amlodipine (5 mg). Among fixed dose combination of two drugs analyzed highest cost difference was found that of hydrochlorothazide (12.5 mg)+olmesartan (40 mg) combination and highest cost ratio and percentage cost variation was of amlodipine (5 mg)+telmisartan (40 mg).Conclusions: There was a huge price variation among the antihypertensive drugs manufactured by various companies. Some measures must be taken by the government to bring the uniformity in the price that will help to reduce the economic burden on the patients

Utilization pattern of antiepileptic drugs and their adverse effects in tertiary healthcare and teaching hospital

Background: Epilepsy is the most common neurological condition with 65 million cases of active epilepsy found worldwide. The incidence is approximately 0.3 - 0.5% in different world populations with a prevalence rate of five to ten per thousand people. The aim of the present study was to evaluate the prescriptions according to WHO/INRUD drug use indicators and to study the adverse effects to antiepileptic drugs (AEDs).Methods: A cross sectional survey based observational study of 1year duration was conducted at tertiary healthcare hospital. Prescription data of patients (n=361) with Epilepsy from Neurology department was analysed using WHO indicators. The demographic data, type of seizures, AEDs prescribed and adverse drug reactions (ADRs) reported by the patients were recorded. Statistical analysis was done using Microsoft excel 2013.Results: A total of 593 AEDs were prescribed to 361 patients. Average number of AEDs prescribed per prescription was 1.65±0.78 (S.D) with only 02% of newer AEDs. Generalized Tonic Clonic (GTC) was the most common seizure with 55.68%. Phenytoin (32%) was commonly prescribed followed by valproate for GTCS. Carbamazepine was commonly prescribed for partial seizures. Out of 15 ADR cases that has been recorded, phenytoin (73%) was associated with most ADRs followed by valproate (20%). 53% patients were on Monotherapy, 31% on dual drug therapy.Conclusions: Older AEDs are still commonly prescribed drugs. Prescription of newer AEDs to be encouraged, as study revealed majority of adverse effects to drugs like phenytoin and valproate. Study concludes the need of creating awareness of reporting of adverse event to AEDs, in treating physician

Carbamazepine induced Stevens Johnson Syndrome: a case report from a tertiary care hospital

Stevens Johnson Syndrome is a rare but life-threatening skin disease and Carbamazepine is considered as one of the most common cause. The reported frequency of serious Carbamazepine hypersensitivity reaction is between 1/1000 and 1/10000 new exposures to the drug. Here, we report a case of a 40 year old female patient, who developed multiple ulcerative lesions all over the body three days after starting treatment with Carbamazepine for Trigeminal Neuralgia. (Worldwide Unique Number- 2017-58502 and AMC Report Number- BJGMC-Pune/Nov-2017/BBG-1860) Stevens Johnson Syndrome was diagnosed. Carbamazepine was withdrawn, and the patient was treated with topical and intravenous antibiotics. A biopsy was done which confirmed the diagnosis of Stevens Johnson Syndrome

Determination of the drug utilization patterns of antimicrobial agents used in the department of ear, nose and throat at a tertiary care teaching hospital

Background: Pharmacoepidemiology deals with the epidemiological aspects of clinical use of and effects of drugs over a large population with intentions to have a rationalised prescription practices while using various drugs preferably anti-microbial agents. Objective of the research was to study the prescribing patterns of drugs in ear, nose and throat (ENT) department and to evaluate prescriptions according to World Health Organization (WHO) drug use indicators.Methods: A cross sectional, observational study was conducted in the department of ENT. Data was collected from the prescriptions of patients in outpatient (OPD) and inpatient department (IPD) both.Results: Total number of 250 prescriptions were analysed in which 1038 drugs were prescribed, with average number of drugs prescribed per prescription were 3.6 and 4.6 drugs among OPD and IPD group respectively. Anti-histaminic class of drugs were most prescribed drugs in OPD while in IPD, all anti-microbial agents were most prescribed class of drugs. There was a statistically significant difference between drugs prescribed by generic and branded names. When compared statistically, it was found that 1%, 59% and 40% prescribed drugs in OPD were from desirable, essential and vital class respectively. While 3%, 62% and 36% of prescribed drugs in IPD were from desirable, essential and vital class respectively.Conclusions: It is vital to aware prescribers about the importance of rationalised prescribing and avoid polypharmacy. A need for the development of prescribing guidelines and educational initiatives to encourage the rational and appropriate use of drugs, in order to give the inputs to the prescribing doctors

Pharmacovigilance programme of India: revival of the renaissance

Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses

A survey on the knowledge, attitude, and practices about antibiotic usage and resistance among homeopathic general practitioners

Background: Antimicrobial resistance(AMR) is an urgent and serious global health problem, demanding considerable attention from health care providers(HCPs) all over the world. The threat is progressing rapidly and intensifying with time. Therefore study was conducted to assess the knowledge, attitude and practices of Homeopathic HCPs about antibiotic usage and resistance(ABR).Methods: Cross-sectional, observational study. The data was collected from 75 Homeopathic HCPs practicing in Maharashtra with prior informed consent. Questionnaire based study whose responses were assessed by using five point Likert scale and analysed by using appropriate descriptive statistics.Results: 68(90.67%) respondents agreed that antibiotics are overused in India and 70(93.33%) of them facing ABR in their daily practices. Only 62(82.7%) of them were aware of the fact that bacteria are not responsible for causing colds and flu. 33(44%) believe that skipping one or two doses of antibiotic does not contribute to ABR. Only 23(30.67%) knew drug schedule H correctly. 22(29.33%) opined that antibiotics should be discontinued if patient develops mild gastrointestinal side effects. Only 28(37.33%) reads patient information leaflet(PIL) and counsel patients accordingly. 28(38.67%) feel that they don’t have enough sources of antibiotic information and 35(46.67%) find it difficult to select appropriate antibiotic.Conclusions: Most of HCPs were aware of rising issue antibiotic resistance. However, their knowledge, attitude and practices were found to be a matter of some concern. Educational intervention can be introduced to bring about behaviour changes regarding rational antibiotics prescribing. Government should take initiative against overt antibiotic promotional advertisements and to curb over the counter(OTC) sell of antibiotics

Comparison of conventional and sustained-release formulation of metformin in type 2 diabetics

Background: To investigate the effects of metformin sustained-release (MSR) compared with metformin immediate-release (MIR) on glycaemic control, blood pressure, lipid profile and metabolic parameters like weight, waist circumference in type 2 diabetes.Methods: A prospective, randomized, double blind study was conducted at tertiary healthcare and teaching hospital at Pune, Maharashtra. After obtaining institutional ethical committee approval and written informed consent, 40 newly diagnosed type 2 diabetic patient were randomly assigned to receive metformin immediate release formulation (MIR) 500 mg once 1 week and then twice daily and metformin sustained release formulation (MSR) 500 mg once 1 week and  then 1000mg once daily for 18 weeks. Fasting and post prandial blood glucose level (BGL), HbA1c, blood pressure, lipid profile, weight and waist circumference, were recorded at the start and end of study.Results: Both MIR and MSR significantly decreased fasting; post prandial BGL and HbA1c at 18 weeks. But no significant difference was seen between two groups. Study did not show any effect on blood pressure and on lipid profile. Both formulations decreased obesity as evident by significant reduction in weight and waist circumference. All patients tolerated both formulations of metformin. Though overall incidences of adverse effects are less with sustained release formulation, difference was not significant between two groups.Conclusions: To conclude, both metformin immediate release and sustained release formulations achieved comparable glycaemic control and sustained release formulation would be as effective as immediate release formulation with advantage of being reduce daily intake of tablets

Comparison of conventional and sustained-release formulation of metformin in type 2 diabetics

Background: To investigate the effects of metformin sustained-release (MSR) compared with metformin immediate-release (MIR) on glycaemic control, blood pressure, lipid profile and metabolic parameters like weight, waist circumference in type 2 diabetes.Methods: A prospective, randomized, double blind study was conducted at tertiary healthcare and teaching hospital at Pune, Maharashtra. After obtaining institutional ethical committee approval and written informed consent, 40 newly diagnosed type 2 diabetic patient were randomly assigned to receive metformin immediate release formulation (MIR) 500 mg once 1 week and then twice daily and metformin sustained release formulation (MSR) 500 mg once 1 week and  then 1000mg once daily for 18 weeks. Fasting and post prandial blood glucose level (BGL), HbA1c, blood pressure, lipid profile, weight and waist circumference, were recorded at the start and end of study.Results: Both MIR and MSR significantly decreased fasting; post prandial BGL and HbA1c at 18 weeks. But no significant difference was seen between two groups. Study did not show any effect on blood pressure and on lipid profile. Both formulations decreased obesity as evident by significant reduction in weight and waist circumference. All patients tolerated both formulations of metformin. Though overall incidences of adverse effects are less with sustained release formulation, difference was not significant between two groups.Conclusions: To conclude, both metformin immediate release and sustained release formulations achieved comparable glycaemic control and sustained release formulation would be as effective as immediate release formulation with advantage of being reduce daily intake of tablets