Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

Users Online : 44428

AbstractMaterial and MethodsResultsDiscussionConclusionAcknowledgementReferencesTable and FiguresDOI and Others
Article in PDF How to Cite Citation Manager Readers' Comments (0) Audio Visual Article Statistics Link to PUBMED Print this Article Send to a Friend
Advertisers Access Statistics Resources

Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2012 | Month : September | Volume : 6 | Issue : 7 | Page : 1248 - 1253 Full Version

Pharmacovigilance: The Extent of the Awareness Among the Final Year Students, Interns and Postgraduates (PGs) in a Government Teaching Hospital


Published: September 1, 2012 | DOI: https://doi.org/10.7860/JCDR/2012/.2474
Hema N.G., Bhuvana K.B., Sangeetha

Abstract

Introduction: Adverse Drug Reactions (ADRs) are encountered commonly in the daily practice. In addition to the obvious morbidity and the mortality which are caused by them, they also cause an economic burden on the health care system. Adverse drug reactions are preventable if the healthcare professional pays close attention to the details of the adverse effects, following a drug administration. An awareness about ADRs can decrease the irrational use of an inappropriate pharmacy. Hence, there is an urgent need to create an awareness among the prescribers (especially junior doctors) about the ADR monitoring.

Objective: The present study was undertaken to assess the awareness, knowledge and the methods of application of pharmacovigilance among the final year MBBS students, interns and post graduates (preclinical, paraclinical and clinical subjects) in a government teaching hospital.

Materials and Methods: A questionnaire which was designed, based on the precedence which was set by previous studies, was standardized and administered to 300 final year students, interns and postgraduates of MMCRI, Mysore. The questionnaire comprised of 25 questions (awareness-5, knowledge-8 and methods of application-12) and each question had only one correct answer. The respondents were graded into 3 categories-poor, unsatisfactory and satisfactory, based on their individual scores. The data was then analyzed by using the contingency coefficient analysis, descriptive statistics and one way ANOVA and the product moment correlation technique was applied for the data analysis by using SPSS for Windows (version 16).

Results: A total of 210 questionnaires were statistically analyzed. It was found that the awareness, knowledge and the methods of application of pharmacovigilance was lesser in the students, as compared to the interns and the postgraduates. The methods of application in the PGs and the interns were considerably higher, probably due to their clinical exposure. It was also observed that higher was the awareness, more was the knowledge and better were the methods of application. They are positively related with a significant correlation coefficient.

Conclusion: The study suggested that it was imperative to include pharmacovigilance in the under graduate training programme, and that the interns and the post graduates should be sensitized to the ADR reporting during their training period. Importance also had to be given to translational pharmacovigilance, to encourage the dissemination of the information which was required, to improve the prescription of the drugs.

Keywords

Pharmacovigilance, Adverse drug reactions, Awareness, Knowledge, Methods of application

Introduction
Since time immemorial, the use of medicines has been associated with adverse effects. “There are 3 actions of a drug: The one you want, the one you don’t want, and the one you don’t know about”( DJP Barker) (1). So, it is crucial to monitor both the known and the unknown adverse effects of medicines. This is because the recent epidemiological studies have estimated that adverse drug reactions are the fourth to sixth leading causes of death and that they represent 5% to 10% of the hospital costs (2). Therefore, in addition to the obvious morbidity and the mortality which are caused by them, ADRs are also an economic burden on our health care system as they prolong the hospital stay and increase the cost of the treatment. In a country like India, with a large population and vast diversity, it is absolutely necessary to introduce a standard pharmacovigilance programme. Pharmacovigilance is by definition “The science and activities which are related to the detection, assessment, understanding and the prevention of adverse effects or any other drug related problems (3)”. India ranks below 1% in terms ofADR reporting against the world rate of 5% (4).To overcome this problem, the Ministry of Health and Family Welfare, Govt. of India, has initiated the National Pharmacovigilance Programme. The purpose of this programme is to collate the data, analyze it and to use the inferences to recommend informed regulatory interventions, besides communicating the risks to the health care professionals and the public. This programme is coordinated by the National Pharmacovigilance Centre at the Central Drugs Standard Control Organization (CDSCO) in New Delhi. The National Centre is operating under the supervision of the National Pharmacovigilance Advisory Committee, to recommend procedures and guidelines for regulatory interventions. This committee oversees the performance of two zonal, five regional and twenty six peripheral pharmacovigilance centres. The entire network works in coordination to improve the ADR reporting in our country (5).

A majority of India’s population prefers government hospitals when they are in need of health care facilities. So, these hospitals can be a good source for generating an ADR database. However, the Herculean task is to foster a culture of reporting among theclinicians, especially among the junior doctors, as they are more closely associated with the patient care. The present low level of ADR reporting is mostly due to a lack of awareness and training and time constraints (6). The manner in which a doctor takes the clinical history of a patient can be improved, if he has a sound knowledge of the drug safety issues, with an emphasis on the patient’s medication history. It also helps him in understanding the action of the drug better. It thus decreases the irrational use of medicines, adverse drug-drug interactions and inappropriate polypharmacy (7).

Few studies had been carried out in different countries to assess the knowledge of pharmacovigilance among the medical students and practitioners. In the U.K., 57% of the medical schools assessed the students’ knowledge on the yellow card scheme (8). In France, a survey which was conducted among medical residents, showed that a majority lacked knowledge on pharmacovigilance (9). A study which was conducted in Nigeria revealed an inadequate knowledge on pharmacovigilance among resident doctors (10). A study which was designed to investigate the awareness of pharmacovigilance among the health care professionals in Jiangsu, China, showed that significant differences existed in the awareness of pharmacovigilance across regions, hospital classes and professions (11). A study which was conducted at a Nepalese hospital also showed low KAP scores and it suggested the need for educational and managerial interventions (12). In India, few studies were carried out, which mainly emphasized on the actual process of the ADR reporting. A study which was conducted at 3 different private hospitals in Mysore recommended that several studies of a similar kind, especially in the community setup, needed to be conducted, to know the attitudes of other health care professionals towards the ADR reporting (13). Hence, the present study was designed with the following objectives:

To Assess
1. a. The awareness on pharmacovigilance . b. The knowledge on pharmacovigilance. c. The methods of application of pharmacovigilance among the final year students, interns and postgraduates. 2. To compare the results among the three groups.

Material and Methods

Study Design
This was a cross sectional, questionnaire based study.

The Study Setting
This study was conducted at the Mysore Medical College and Research Institute, Mysore (MMCRI). This is one of the oldest government medical colleges in Karnataka which was started in 1924. Today, it is a 1050 bedded tertiary care hospital with an outpatient turnover of about three lakhs, annually.

The Study Population
This was a non-interventional study which was done among the final year MBBS students, interns and the postgraduates who were studying medical, surgical, paraclinical and clinical subjects at MMCRI, Mysore. Those who were not willing to participate and those who did not return the questionnaires in the stipulated time were excluded from the study. However, a prior approval forconducting this study was obtained from the institutional ethics committee of this college.

The Study Instrument
The study instrument was a predesigned questionnaire which was structured by following the precedence which was set by similar studies. It was validated. The study questionnaire was designed to assess the awareness, knowledge and the methods of application of pharmacovigilance among the study population. • The term ‘awareness’ meant the perception of a situation or a fact. • ‘Knowledge’ meant the theoretical or practical understanding of a subject. • ‘Method of application’ was the practical application of pharmacovigilance. • The questionnaire comprised of 25 questions (awareness – 5, knowledge-8 and methods of application-12).

The Study Conduct
The questionnaire was administered to 300 final year MBBS students, interns and postgraduates (from all specialities) who were working at MMCRI, Mysore. The participants were personally briefed about the questionnaire and they were requested to return the duly filled in forms. The participants were given 30 minutes to answer the questionnaire and they were not allowed to consult anyone during that time. They could maintain anonymity with regards to their names, but they had to write their designations. The questionnaire was designed in such a way that each question had only one correct answer. The answers to the questions were not mutually exclusive. The questionnaires were then evaluated. One point was given to each answered question (max total – 25 points). The awareness level was evaluated, based on the questions, 1 to 5, the knowledge of the respondents was evaluated as per their responses to the questions, 6 to 13 and the methods of application were evaluated, based on the answers to the questions, 14 to 25. The questionnaires were then analyzed by grading the respondents into 3 categories: poor, unsatisfactory and satisfactory, based on the table which has been given below.

The compiled data was then analyzed by using the following statistical methods – contingency coefficient analysis, descriptive statistics, Chi square test and One way ANOVA and the product moment correlation technique was applied for the data analysis by using SPSS for Windows (version 16).

Results

The questionnaire was administered to 300 participants, of whom 132 were post graduates from various departments, 88 were interns and 80 were final year MBBS students. A total of 210 questionnaires were returned, thus giving a response rate of 70% (post graduates -76%, interns -56% and final year students -75%).The descriptive statistics indicated that the mean awareness and the knowledge scores of the students were lower than those of the interns and the post graduates. The mean scores of the methods of application were considerably higher among the post graduates and the interns as compared to those among the students. The correlations revealed that the level of awareness among the respondents was significantly related to the knowledge and the1250methods of application of pharmacovigilance, linearly and positively with correlation coefficients of 0.346 and 0.444, with significance levels of 0.001 and 0.001 respectively. In other words, the higher the awareness, more was the knowledge and better were the methods of application. Likewise, the knowledge and the methods were significantly and positively related to a correlation coefficient of 0.485 and a significance level of 0.001.

Discussion

The innumerable social and economic consequences of adverse drug reactions cultivate a need to actively involve health care professionals in the pharmacovigilance programme. The main aims of pharmacovigilance are the early detection of the adverse reactions and interactions, monitoring the frequency of the adverse reactions, identification of the risk factors for the adverse reactions and dissemmation of the information which is required to improve the prescription of drugs. So, the main prerequisite of pharmacovigilance is the reporting of suspected adverse drug reactions (14). A proper coordination amidst the health care professionals and the medical institutions is the most required for a successful pharmacovigilance programme . Many factors are associated with the adverse drug reaction under reporting among the healthcare professionals. But basically, in order to improve the reporting rate, it is important to properly educate the healthcare professionals regarding ADR reporting/ pharmacovigilance. The most appropriate time to do so, is during the undergraduate and the postgraduate training of the doctors. This study endeavoured to evaluate the extent of the awareness,knowledge and the methods of application of pharmavovigilance of the final year MBBS students, interns and postgraduates of a government teaching hospital. Some Indian studies which were conducted at the Lady Harding Medical College. New Delhi, showed that the knowledge, attitude and the practices of both the undergraduates and the prescribers were comparable, but that they needed further improvement (15). A similar study which was conducted at the Civil hospital, Ahmedabad, concluded that under reporting and a lack of knowledge about the reporting system were clearly evident among the prescribers (16). A study which was conducted at two government teaching hospitals, B.J. Medical College, Pune and Seth G.S. Medical College, Mumbai, also revealed that the awareness on the reporting systems was very low amongst the resident doctors (17). A cross sectional, questionnaire based, multi-centric study which was done on six different medical colleges in Gujarat indicated that the overall knowledge of pharmacovigilance was poor in undergraduate medical students (18). A study which was conducted at a paediatric tertiary care centre in Bangalore suggested that educational interventions and the improvement of the facilities would help in enhancing the reporting rate (19). A study which was conducted in Malaysian Public Universities on pharmacy students, suggested that a customized comprehensive curriculum which was related to pharmacovigilance should be designed and implemented in the pharmacy schools (20).

In this study, we assessed the awareness, knowledge and the methods of application of pharmacovigilance among 3 different groups of respondents. This is because students, interns and post graduates can play a major role in interacting with patients in the clinical departments. They are also an invaluable source for collecting, analyzing and reporting ADRs. The mean awareness score of the students (2.45) was lower than that of the interns (3.06) and the post graduates (3.35). Many (74%) were unaware that pharmacovigilance, in addition to drug related problems, included blood related products, herbal products, medical devices and vaccines. The mean knowledge score of the students (2.30), was lower than that of the interns (3.20) and the post graudates (3.46). A vast majority (89.5%) were ignorant of the number of centers under the national pharmacovigilance programme. Several (80.5%) did not know when the National Pharmacovigilance Programme had officially commenced. A considerable number were ignorant about the schedule Y (75%) and archiving (81%).

In the methods of application of pharmacovigilance, the postgraduates had a considerably higher mean score of 6.94 as compared to the interns, with a mean score of 5.65 and the students had a much lower score of 3.18.This difference can be attributed to the greater clinical exposure of the former two. However, a majority (53.3%) were not aware that even nurses and pharmacists could report adverse drug reactions. A large number (69.5%) did not know the various methodologies which were employed to assess the causality of the adverse effects (the WHO Assessment Scale, the Naranjo Scale, the European ABO System, etc). A considerable number (59%) were not sure when a de-challenge was not applicable in case of the adverse drug reactions. The above observations indicated that serious measures had to be taken to educate the junior doctors about these aspects ofpharmacovigilance. Numerous studies have revealed that many physicians were unaware of the pharmacovigilance programmes and the ADR reporting systems which existed in the country. These studies also attempted to identify the possible measures that could enhance the involvement of physicians in the pharmacovigilance programme. These measures included, creating an awareness about pharmacovigilance, implementing ADR reporting as an integral part of the undergraduate, internship and post graduate training, providing active manpower to collect the ADR reports from busy clinicians, provision of the feedback to the reporting healthcare professionals and the involvement of nurses and paramedical staff in reporting the ADRs. To facilitate the activity of pharmacovigilance, a culture of learning about it should start early in the professional training of the health care students. This enables the medical students to realize that all medicines can cause adverse drug reactions. In addition, their responsibility of participating in the National Pharmacovigilance Programme is emphasized. Consequently, the rational use of medicines, the adverse drug-drug interactions and the inappropriate polypharmacy have been considerably to be reduced in the clinical practice.

An outline of the adverse drug reactions is covered in most of the pharmacology text books. However, the students are not adequately trained to apply this knowledge in practice. The theoretical knowledge on pharmacovigilance, the National Pharmacovigilance Programme and its centres and ADR monitoring should be included in the syllabus. The actual practical knowledge can be gained by visiting a pharmacovigilance centre and by observing its functioning. Both the interns and the post graduates are invaluable sources for collecting, analyzing and reporting ADRs. They play a major role by interacting with the patients and their peers in the clinical departments. They should be familiarized with the ADR reporting and the methods for assessing the causality and the severity of ADRs. Continued Medical Education programmes and other training programmes can help in sensitizing them. The interns can be posted to the pharmacovigilance centres. Suitable measures have to be taken to alert them to prevent ADRs. In addition, every institution should conduct monthly meetings to monitor ADRs. All the departments should compulsorily participate in such meetings and provide an active feedback. Incentives should be given to promote the reports on ADRs. Even organizing regular quiz programmes for both the staff and the students can foster a better means of creating an awareness about pharamacovigilance. Importance should be given to translational pharmacovigilance to encourage the dissemination of the information which is required to improve the prescriptions of drugs.

Conclusion

Today, the need for an efficient pharmacovigilance system has been realized more than ever, to ensure the safe use of medicines. Pharmacovigilance is being taught to some extent in theory, but the knowledge on the practical approach is lacking. The present academic curriculum should be revised to include the application of pharmacovigilance in the medical practice. A culture of learning about pharmacovigilance should start early in the professional training of doctors. The medical students who are aware of pharmacovigilance are sure to realize that all medicines can cause ADRs. Moreover, they, by participating in the NationalPharmacovigilance Programme, can detect the adverse effects which result from the drug use in the population. This will definitely decrease the irrational use of medicines and emphasis should be made on the ADR detection and reporting.

Acknowledgement

We acknowledge the encouragement and the support of DR. B.M. Parashivamurthy, Professor and H.O.D, Department of Pharmacology M.M.C.R.I, Mysore.

References

1.
SK Gupta. Post marketing Surveillance, Text book of Pharmacovigilance, First edition, Jaypee Brothers Medical Publishers(P) Ltd., 2011;75.
2.
Srinivasan R, Ramya G. Adverse drug reaction causality assessment. International Journal of Research in Pharmacy and Chemistry. 2011; 1(3): 606-11.
3.
The World Health Organization. Safety of Medicines: A guide for detecting and reporting adverse drug reactions. Geneva :2002 WHO / EDM / QSM / 2002.2.
4.
The National Pharmacovigilance Protocol, Ministry of Health and Family Welfare, Govt of India.
5.
Prakash S. Pharmacovigilance in India. Indian J Pharmacol. 2007; 39: 123.
6.
Amit D, Padmanabh V. Rataboli. The adverse drug reaction (ADR) notification drop box: An easy way to report ADRs. Br. J Clin Pharmacol. 2008 November; 66(5): 723-24.
7.
Ravi SP, Subish P, Mishra P, Dubey AK. Teaching pharmacovigilance to medical students and doctors. Indian J Pharmacol. Sept-Oct, 2006;38( 5 ): 316-19.
8.
Cox AR, Marriott JF, Wilson KA, Ferner RE. Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes. J. Clin Pharm Ther. 2004 Feb; 29(1): 31-35.
9.
Graille V, Lapeyre–Mestre M, Mon Tadric JL. Drug vigilance: An opinion survey which was conducted among the residents of a university hospital. Therapie. 1994 Sep-Oct; 49(5): 451-54.
10.
Ohaju-Obodo, JO, Iribhog be OI. The extent of pharmacovigilance among the resident doctors in the Edo and the Lagos states of Nigeria. Pharmacoepidemiology and Drug Safety. 2010;19: 191-95.
11.
Xu H, Wang Y, Liu N. A hospital based survey on health care profes-sionals in the awareness of pharmacovigilance. Pharmacoepidemioly and Drug Safety, 2009 July;18(7) : 624-30.
12.
Subish P, Izham MM, Mishra P. Evaluation of the knowledge, attitudes and the practices on adverse drug reactions and pharmacovigilance among the health care professionals in a Nepalese hospital: A preliminary study. The Internet Journal of Pharmacology. 2008; 6(1): 1531-2976.
13.
Ramesh M, Parthasarathi G. Adverse drug reaction reporting: the attitudes and the perceptions of the medical practitioners. Asian Journal of Pharmaceutical and Clinical Research. April-June 2009;2 (2):10-14.
14.
Gupta SK. Setting up a Pharmacovigilance Center, Text book of Pharmacovigilance. First edition, Jaypee brothers Medical Publishers, 2011; 93-103.
15.
Rehan HS, Vasudev K, Tripathi CD. Adverse drug reaction monitoring: the knowledge, attitude and the practices of the medical students and the prescribers. Natl Med J India. 2002 Jan-Feb; 15(1): 24-6.
16.
Desai, et al. An evaluation of the knowledge, attitude and the practice of adverse drug reaction reporting among the prescribers at a tertiary care hospital. Perspective in Clinical Research. Oct-Dec 2011; 2(4): 129-35.
17.
Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: knowledge, attitudes and perceptions among the resident doctors. J. Pharm Sci Res 2011; 3:1064-69.
18.
Vora, et al, Knowledge on the adverse drug reactions and the pharmacovigilance activity among the undergraduate medical students of Gujarat. IJPSR. 2012; 3(5): 1511-15
19.
Muraraiah S, et al. A questionnaire study which was done to assess the knowledge, attitude and the practice of pharmacovigilance in a paediatric tertiary care centre. J Chem. Pharm.Res., 2011;3( 6 ): 416-22.
20.
Elkalmi R, et al. Pharmacy students’ knowledge and perceptions about pharmacovigilance in Malaysian public universities. American Journal of Pharmaceutical Education 2011; 75 ( 5 ) Article 96. APPENDIX-1 Tick the correct answer Students/Interns/PGs Awareness 1. Are you aware of the term of pharmacovigilance? Yes /No 2. Is it mandatory to have pharmacovigilance unit in the medical college? Yes/No 3. What is pharmacovigilance? a. Adverse drug reaction (ADR) monitoring b. Therapeutic drug monitoring c. Vigilance over the pharma company for drug production d. All 4. Pharmacovigilance includes a. Drug related problems b. Blood related products c. Herbal products d. Medical devices and vaccines e. All 5. Aim of the pharmacovigilance is to assess a. Safety over efficacy b. Efficacy over safety Knowledge 6. Under the National Pharmacovigilance Programme, all are true except a. 26 Peripheral Pharmacovigilance Centres ( PPC ) b. 4 Regional Pharmacovigilance Centres ( RPC ) c. 2 Zonal Pharmacovigilance Centres ( ZPC ) d. None 7. National pharmacovigilance programme (NPP) was officially inaugurated at New Delhi in the year a. 2002 b. 2004 c. 2006 d. 2008 8. AIIMS New Delhi is a a. Peripheral Pharmacovigilance Centre b. Regional Pharmacovigilance Centre c. Zonal Pharmacovigilance Centre d. National Pharmacovigilance Centre 9. Pharmacovigilance in clinical research is the responsibility of a Sponsorers b. Investigator c. Ethical committee d. All 10. Schedule Y was developed in a. 1968 b. 1978 c. 1988 d. 1998 11. Archiving is to be done for a period of a. 2 yrs b. 3 yrs c. 4 yrs d. 5 yrs 12. Is audit of pharmacovigilance mandatory Yes / No Methods Of Application 13. Co-ordinator’s eligibility at ZPC should be a. A Pharmacologist preferably not below the rank of an assistant professor b. A Pharmacologist preferably not below the rank of an associate professor c. A Pharmacologist not below the rank of professor d. Any of the above 14. Most common type of ADR? a. Type A b. Type B c. Type C d. Type D 15. Which of the following defines serious adverse event? a. Life threatening b. Disability c. Death d. Hospitalization 16. ADR reporting can be done by a. Doctors b. Nurses c. Pharmacists d. All 17. ADR reporting done for all except a. New drugs b. Old drugs c. Any reaction or even minor reaction of new drug d. Any reaction or even minor reaction of old drug 18. ADR report submission follows which order a. Peripheral pharmacovigilance centre (PPC) → Regional pharmacovigilance centre (RPC) → Zonal Pharmacovigilance Centre ( ZPC ) b. RPC → PPC → ZPC c. ZPC → RPC → PPC d. Any order19. Methodologies employed to assess causality of adverse effect is/are a. WHO assessment scale b. Naranjo’s scale c. Europeon ABO system d. All 20. ADR forms are called a. Yellow card b. Red card c. Green card d. Pink card 21. Elements which are mandatory to record a. Identifiable patient details b. Identifiable reporter details c. Suspected medicinal products d. All 22. Dechallenge is not applicable when the a. Drug is one dose treatment b. Reaction had occurred after drug was discontinued c. Lack of efficacy d. All 23. Is ADR synonymous to adverse event? Yes /No 24. The commonly seen ADRs like headache, fever, vomiting has to be reported Yes / No 25. Non Medical people can report ADR to a near by medical person Yes / No If yes by what means of communication a. Orally b. Telephone c. E mail d. All

DOI and Others

ID: JCDR/2012/4216:2474

Date of Submission: Mar 01, 2012
Date of Peer Review: Mar 17, 2012
Date of Acceptance: Jul 30, 2012
Date of Publishing: Sep 30, 2012

JCDR is now Monthly and more widely Indexed .
  • Emerging Sources Citation Index (Web of Science, thomsonreuters)
  • Index Copernicus ICV 2017: 134.54
  • Academic Search Complete Database
  • Directory of Open Access Journals (DOAJ)
  • Embase
  • EBSCOhost
  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com