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

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

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

Hemovigilance: a momentous step to blood safety

Hemovigilance is a series of monitoring procedures that cover the entire transfusion chain, from blood and its component collection to recipient follow-up, collecting and collecting information about unexpected or adverse effects resulting from the therapeutic use of unstable blood products. It is designed to be evaluated, and to prevent their occurrence and recurrence. The Haemovigilance program in developed countries is associated with IHN and has voluntary reporting requirements. In France, Germany and Switzerland, the hemodynamic system is regulated by supervisors. It is one of the blood manufacturers in Japan, Singapore and South Africa. In the Netherlands and the United Kingdom within the Medical Society; in Canada, regulated by health authorities. Intensive blood exercise program to ensure patient safety and promote public health begins on December 10, 2012 in Phase 1 in collaboration with National Institute of Biological Sciences under MOHFW for the first time in India it was done. HvPI is responding very well, as most medical colleges and laboratories have already registered and are beginning to provide data on side effects. The HvPI Unit produces educational materials in the form of publishing the Haemovigilance newsletter, information, education and communication (IEC) literature, and conducts an academic CME and awareness program on Haemovigilance throughout the year in India. The provocation is to understand not only the feedback of the internet, but even the sociology of human networks. Guaranteeing the reliability, responsiveness, and feedback of each alert is also important. Blood products are an important area of PvPI for reporting and recording post-transfusion ADRs of blood / blood products. To work efficiently, a lean mechanism and proper coordination with standardized tools at all levels is needed

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