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   2016| October-December  | Volume 7 | Issue 4  
    Online since October 12, 2016

 
 
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EDITORIAL
Are registered ethics committees empowered to ensure human research protection?
Arun Bhatt
October-December 2016, 7(4):149-151
DOI:10.4103/2229-3485.192028  PMID:27843787
  1,493 3,093 -
ORIGINAL ARTICLES
A study of medication errors in a tertiary care hospital
Nrupal Patel, Mira Desai, Samdih Shah, Prakruti Patel, Anuradha Gandhi
October-December 2016, 7(4):168-173
DOI:10.4103/2229-3485.192039  PMID:27843792
Objective: To determine the nature and types of medication errors (MEs), to evaluate occurrence of drug-drug interactions (DDIs), and assess rationality of prescription orders in a tertiary care teaching hospital. Materials and Methods: A prospective, observational study was conducted in General Medicine and Pediatric ward of Civil Hospital, Ahmedabad during October 2012 to January 2014. MEs were categorized as prescription error, dispensing error, and administration error (AE). The case records and treatment charts were reviewed. The investigator also accompanied the staff nurse during the ward rounds and interviewed patients or care taker to gather information, if necessary. DDIs were assessed by Medscape Drug Interaction Checker software (version 4.4). Rationality of prescriptions was assessed using Phadke's criteria. Results: A total of 1109 patients (511 in Medicine and 598 in Pediatric ward) were included during the study period. Total number of MEs was 403 (36%) of which, 195 (38%) were in Medicine and 208 (35%) were in Pediatric wards. The most common ME was PEs 262 (65%) followed by AEs 126 (31%). A potential significant DDIs were observed in 191 (17%) and serious DDIs in 48 (4%) prescriptions. Majority of prescriptions were semirational 555 (53%) followed by irrational 317 (30%), while 170 (17%) prescriptions were rational. Conclusion: There is a need to establish ME reporting system to reduce its incidence and improve patient care and safety.
  2,648 582 2
OPINION
Involvement of general public in biomedical research
CS Pramesh, R Venkataramanan, Viraj Suvarna, Nishu Singh Goel, S Lakshman, Viji Venkatesh, Vandana Gupta, Rajendra Badwe
October-December 2016, 7(4):152-155
DOI:10.4103/2229-3485.192029  PMID:27843788
Biomedical research is crucial for any country's progress and the health of its ethnic population. This effort needs to be sustained and well supported for it to bear optimum results. The major stakeholders in medical research are the general public, patients, researchers, physicians (and medical institutions), the pharmaceutical industry, regulatory authorities, and the government. Much of the pressure to perform cutting edge research in developed countries is driven by the general public; however, this has been conspicuous by its absence in India. This is largely due to misconceptions that medical research in developing countries is an experimental exercise using human beings as guinea pigs, primarily benefiting only the pharmaceutical industry and a general lack of awareness about the importance of original research within the country. This editorial addresses various issues related to public involvement in biomedical research and suggests the need for solutions and imperative remedial measures.
  1,494 1,581 2
REVIEW ARTICLES
Real world evidence: An Indian perspective
Amit Dang, BN Vallish
October-December 2016, 7(4):156-160
DOI:10.4103/2229-3485.192030  PMID:27843789
Randomized controlled trials (RCTs) are the gold standard for measuring the safety and efficacy of drugs. However, they are being challenged by payers and health care providers since they are looking for real world evidence (RWE) to validate whether the new intervention provides similar safety and efficacy as reported in RCT data. RWE uses real world data (RWD) to generate insight, foresight, and explorative findings on diseases, products, and patient populations. There are varied sources of RWD such as administrative data, large pragmatic trials, registries, electronic health records, and health surveys. RWE approaches are increasingly becoming the normal practice in developed countries to bring a product to the healthcare market and to ensure its significance in clinical practice. The Indian healthcare sector is growing at a brisk pace and is grasping up with the principles of health economics and outcome research, thereby exhibiting the value of real-world insights in healthcare decision. India has taken a step toward RWE by developing a framework to assist health care providers in harmonizing RWD for economic, clinical, and humanistic outcome.
  2,180 518 4
STATISTICS
Common pitfalls in statistical analysis: The use of correlation techniques
Rakesh Aggarwal, Priya Ranganathan
October-December 2016, 7(4):187-190
DOI:10.4103/2229-3485.192046  PMID:27843795
Correlation is a statistical technique which shows whether and how strongly two continuous variables are related. In this article, which is the eighth part in a series on 'Common pitfalls in Statistical Analysis', we look at the interpretation of the correlation coefficient and examine various situations in which the use of technique of correlation may be inappropriate.
  2,101 500 6
REVIEW ARTICLES
Trends in clinical trials of dengue vaccine
Priya Marimuthu, Jamuna Rani Ravinder
October-December 2016, 7(4):161-164
DOI:10.4103/2229-3485.192035  PMID:27843790
Dengue is one of the most important vector-borne disease and an increasing problem worldwide because of current globalization trends. Roughly, half the world's population lives in dengue endemic countries, and nearly 100 million people are infected annually with dengue. India has the highest burden of the disease with 34% of the global cases. In the context of an expanding and potentially fatal infectious disease without effective prevention or specific treatment, the public health value of a protective vaccine is clear. There is no licensed dengue vaccine is available still, but several vaccines are under development. Keeping in view the rise in dengue prevalence globally, there is a need to increase clinical drug and vaccine research on dengue. This paper briefly reviews on the development and current status of dengue vaccine to provide information to policymakers, researchers, and public health experts to design and implement appropriate vaccine for prophylactic intervention.
  2,033 405 1
ORIGINAL ARTICLES
An analysis of serious adverse drug reactions at a tertiary care teaching hospital
Kinjal Prajapati, Mira Desai, Samidh Shah, Jigar Panchal, Jigar Kapadia, Ramkumar Dikshit
October-December 2016, 7(4):181-186
DOI:10.4103/2229-3485.192044  PMID:27843794
Objective: The objective of this study was to analyze the various aspects of serious adverse drug reactions (serious ADRs) such as clinical presentation, causality, severity, and preventability occurring in a hospital setting. Materials and Methods: All serious ADRs reported from January 2010 to May 2015 at ADR Monitoring Centre, Department of Pharmacology, B. J. Medical College and Civil Hospital, Ahmedabad, were selected as per the World health Organization -Uppsala Monitoring Center (WHO-UMC) criteria. A retrospective analysis was carried out for clinical presentation, causality (as per the WHO-UMC scale and Naranjo's algorithm), severity (Hartwig and Siegel scale), and preventability (Schumock and Thornton criteria). Results: Out of 2977 ADRs reported, 375 were serious in nature. The most common clinical presentation involved was skin and appendageal disorders (71, 18.9%). The common causal drug group was antitubercular (129, 34.4%) followed by antiretroviral (76, 20.3%) agents. The criteria for the majority of serious ADRs were intervention to prevent permanent impairment or damage (164, 43.7%) followed by hospitalization (158, 42.1%). Majority of the serious ADRs were continuing (191, 50.9%) at the time of reporting, few recovered (101, 26.9%), and two were fatal. The majority of serious ADRs were categorized as possible (182, 48.8%) followed by probable (173, 46.1%) in nature. Conclusion: Antitubercular, antiretroviral, and antimicrobial drugs were the most common causal drug groups for serious ADRs. This calls for robust ADR monitoring system and education of patients and prescribers for identification and effective management.
  1,827 312 3
Evaluation of performance of the Medical Research Department in 'Research naive' non-academic hospital: An audit
Mukta Sunil Kuyare, Parag Vijayrao Sarve, Komal S Dalal, Raakhi K Tripathi
October-December 2016, 7(4):174-180
DOI:10.4103/2229-3485.192041  PMID:27843793
Introduction: Conducting medical research is not limited to academia and pharmaceutical industry but even multispeciality hospitals need to venture in this area along with patient care. To develop research culture among well-established non-acedemic hospital is always difficult and challenging task. This article attempts to evaluate the performance of the department in 'Research naοve' hospital in the last two years and review the strengths and challenges it faced at each step. Methods: This was a retrospective document analysis study evaluating the steps towards setting and sustaining of Medical Research Department of Bhaktivedanta Hospital during the period of January 2013 to June 2015 (30 Months). The authors developed a checklist (along with performance indicators) to assess the Preparatory phase and Activity phase of the research department which were evaluated by Institute Quality Management Team .Each step of both phases was also reviewed in terms of strengths and challenges as perceived by the authors. Results: During 2 year journey of research naοve Hospital, Institute had witnessed Hospital initiated (n=24, 59%) and sponsored projects (n=17, 41%) in all specialties. HRC reviewed (n=2.13) projects per meeting for administrative consideration while IEC reviewed (n=2.15) projects for scientific and ethical review. Challenges during preparatory phases were circumvent by immense cooperation of hospital management for initial investment, sensitization through research workshops for consultants, established procedures and trained support manpower and constant encouragement by research coordinator. Conclusion: Considering evaluation of 41 studies in very first 2 years in 'Research naive non academic institute demonstrated successful implementation of trio model of Hospital Research Committee for administrative review, IEC for scientific-ethical review, centralized MRD for coordinating all research projects under one roof which may act as role model for Research naive institutes
  1,901 190 -
An audit of the approval letters issued by Drugs Controller General of India to Ethics Committees in India
Shruti S Bhide, Jahnavi V Katkar, Mitesh Maurya, Nithya Jaideep Gogtay, Urmila M Thatte
October-December 2016, 7(4):165-167
DOI:10.4103/2229-3485.192037  PMID:27843791
Aim: The present study is an audit of the communiquιs issued by the Drugs Controller General of India [DCGI] to Ethics Committees [ECs] for content and directives after the mandatory notification of registration of Ethics Committees issued on 8 th February 2013. Methods: All letters were downloaded from the website of the Central Drugs Standard Control Organization [CDSCO] and evaluated for the date of issue, number of directives, domains covered by the directives [general instructions, administrative requirements and quorum requirements], median time to approval for registration and time elapsed between date of application and issue of the approval letter. Results: There were a total of 1036 EC letters listed on the website, from which 854 [82.4%] could be downloaded. A working denominator of 841 was arrived at after discarding repeat letters and those that had an incorrect address. The state of Maharashtra had the highest number of ECs registered (209/841, 24.9%) followed by Gujarat [97/841, 11.5%) and Karnataka [96/841, 11.4%]. The number of directives within each letter ranged from 8-22. The overall time to approval was 77.5 [24-919] days and the time to approval between Institutional and Independent Ethics Committees was significantly different. Conclusions: The office of the DCGI had a very wide time range for approving registration of Ethics Committees that ranged from less than a month to more than two years. The quality and nature of the directives improved with time. As the country moves towards accreditation, letters issued by the DCGI should have uniformity. The large number of ECs in a single state and lack of even a single one in several others is something that needs to be addressed by policy makers.
  1,214 193 -
LETTER TO EDITOR
Knowledge about clinical trial agreement and clinical trial related insurance among Ethics Committee members: A cross-sectional survey
Kannan Sridharan, Siddharth Deshpande, Subodh Sirur, Nithya J Gogtay, Urmila M Thatte
October-December 2016, 7(4):191-192
DOI:10.4103/2229-3485.192048  PMID:27843796
  986 145 -
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