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

Users Online : 43061

AbstractMaterial and MethodsResultsDiscussionConclusionAcknowledgementReferences
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 : 2010 | Month : June | Volume : 4 | Issue : 3 | Page : 2427 - 2432 Full Version

Education Sessions For Pharmacy Students On Pharmacovigilance: A Preliminary Study


Published: June 1, 2010 | DOI: https://doi.org/10.7860/JCDR/2010/.739
SUBISH P,,, MOHAMED IZHAM MI, MISHRA P*,**, SHANKAR PR, ALAM K ,

*Department of Pharmacology *** Department of Hospital and Clinical Pharmacy Manipal College of Medical Sciences/ Manipal Teaching Hospital Phulbari-11, Pokhara, Nepal. ***Discipline of Social and Administrative Pharmacy School of Pharmaceutical Sciences Universiti Sains Malaysia, 11800 Penang, Malaysia. ****Department of Clinical Pharmacology KIST Medical College, Imadol Lalitpur, Nepal.

Correspondence Address :
P. Subish M.Pharm
Assistant Professor
Department of Hospital and Clinical Pharmacy/ Pharmacology
Manipal Teaching Hospital/ Manipal College of Medical Sciences
Pokhara, Nepal.
Phone: +977 61 526416 Extn: 130/221
Email:subishpalaian@yahoo.co.in, subishpalaian@gmail.com

Abstract

Introduction: In Nepal, there are no mandatory clinical trials for new products. Drugs are approved based on the data from developed countries. Manipal Teaching Hospital is one of the pioneers in establishing the Pharmacovigilance program in Nepal. For the past three years, the students of Pokhara University visit the Pharmacovigilance center, Drug information center and the Hospital Pharmacy of MTH for a 15 days training program. In the year 2007, the students were also trained in pharmacovigilance.
Objectives: To study the demographical details of the students who participated in the pharmacovigilance training and to obtain student feedback regarding the sessions.
Methodology: The session module was activity based and emphasized the following four areas: sketching out the current National Pharmacovigilance programme, designing an adverse drug reaction reporting form, carrying out the causality assessment and severity assessment. The feedback of the students on the training module was evaluated using the specially designed feedback form.
Results: Altogether, thirty students [males 18 (60%) and females 12 (40%)] were present and all of them participated in the study. The Mean ± SD overall feedback score was 81.5 ± 4.4 (maximum possible score was 100). In general, male students had a higher score (82.29 ± 4.88) than females (80.33 ± 3.75).
Conclusion: Overall, the students liked the session and were interested in having similar sessions in the future. This module can be taken as a model for other researchers who would like to carry out educational sessions in pharmacovigilance for pharmacy students.

Keywords

Education, Nepal, Pharmacy students, Pharmacovigilance

Introduction
It is a well known phenomenon that new drugs are marketed widely and are often withdrawn from the market due to the Adverse Drug Reactions (ADRs) which occur once they are used by a larger population than that covered in the clinical trials (1). Modern pharmacists consider Pharmaceutical care as their focus and play an important role in patient care (2). Ensuring the safe use of drugs is a combined responsibility of the healthcare team that includes Doctors, Nurses, Pharmacists and other supporting staff. One of the most importance means of ensuring drug safety is by reporting ADRs by healthcare professionals. Pharmacists being more knowledgeable in drug related aspects, have an important role in ensuring drug safety. The involvement of pharmacists in pharmacovigilance programs is considered to be vital (3),(4),(5). However, contrary to their important role, studies from developed countries have acknowledged either a poor knowledge (6) or less experience among pharmacists regarding ADR reporting (7). Researchers suggest the need for education for the pharmacists on Pharmacovigilance (8). One of the better ways to do this is by providing education when they are still students. The education provided for the Pharmacy students, even in developed countries like the United Kingdom, was found to be inadequate. A study found that both medicine and pharmacy courses differed substantially in teaching about the Yellow Card Scheme (the scheme for spontaneous ADR reporting in UK) and ADRs. There is scope for increased involvement of the Medicines and Healthcare products Regulatory Agency in undergraduate education (9).

In Nepal, there are no mandatory clinical trials for new products and drugs are approved, based on the data from developed countries. This eliminates the possibility of knowing the risks involved in the Nepalese population. Recently, Pharmacovigilance programs have been started in Nepal (10). Manipal Teaching Hospital is one of the pioneers in establishing the Pharmacovigilance program in Nepal and the members of the Department of Hospital and Clinical Pharmacy and Pharmacology were actively involved in establishing the program (10). The members have already carried out Pharmacovigilance sessions for undergraduate MBBS students (11),(12). However, such an initiative was not carried out for the Pharmacy students. Pokhara University runs a four year B.Pharm course. For the past three years, the students of Pokhara University visit the Pharmacovigilance center, Drug information center and the Hospital Pharmacy of MTH for a 15 days training program. The students had their training during the month of June 2007. During that time, the members of the Pharmacovigilance center conducted a voluntary Pharmacovigilance training module for the Pokhara University Final year Pharmacy students. The present study was conducted with the following objectives.

1. To study the demographic details of the students who participated in the pharmacovigilance training,

2. To study the student feedback regarding the sessions, and

3. To compare the scores of the students based on their demographic status.

Material and Methods

For the past three years, the final year B. Pharm students were trained in various aspects of Hospital and Clinical Pharmacy at the Manipal Teaching Hospital (MTH). The total training period of 15 days is divided into small slots of 2-3 days at the Drug Information center, Pharmacovigilance Center, Inpatient Pharmacy, Outpatient Pharmacy, Bulk Pharmacy and the Medication Counseling center. Besides running the hospital pharmacy, the Department of Hospital and Clinical Pharmacy, with the help of the Department of Pharmacology, also runs a medication counseling center, a drug information center and a pharmacovigilance center. The Pharmacovigilance activities have been going on since September 2004 and now MTH is the regional Pharmacovigilance Center for ADR monitoring for the Western region of Nepal.

During the 15 days training program, the students were also provided training in Pharmacovigilance. The module was activity based and focused on the following four areas: sketching out the current National Pharmacovigilance programme, designing an adverse drug reaction reporting form and carrying out causality assessment and severity assessment of ADRs. Students were divided into groups of five students each. The details are listed below.

Part I: Sketching out the current National Pharmacovigilance programme: The students were asked to sketch out the National Pharmacovigilance programme of Nepal.

Part II: Designing an adverse drug reaction reporting form: Students were encouraged to design an ADR reporting form by themselves. They were instructed that the form should be brief, concise and should have all the essential information required for an ADR reporting form.

Part III: Carrying out the causality assessment: Students were asked to carryout the causality assessment of four ADRs that were reported to the Phamacovigilance center. Naranjo algorithm (13) was provided to the students to carry out the causality assessment.

Part IV: Carrying out the severity assessment: Students were also asked to carry out the severity assessment of four ADRs that were reported to our PV center. Modified Hartwig and Siegel scale (14) was provided to the students to carry out the severity assessment. These four ADRs were the same as those used for causality assessment.

The feedback of the students on the training module was evaluated using the specially designed feedback form (Table/Fig 1).

Results

Altogether, thirty students were present and all of them participated in the study. The demographical characteristics of the students are listed in (Table/Fig 2) .


Student Feedback on the Sessions
The median scores of the individual statements are listed in (Table/Fig 3). The Mean ± SD overall score was 81.5 ± 4.4 (maximum possible score was 100). We also compared the scores with the demographical status of the respondents and the details are listed in (Table/Fig 4).

Discussion

Pharmacovigilance, previously more often referred to as adverse drug monitoring or drug surveillance is now regarded as the quality control system of the society regarding the use of medicines. Its broader aim is to check if medicines fulfill their intended role in alleviating human suffering and reducing disease related economic loss, with the best acceptable safety in use. The ultimate aim of pharmacovigilance is to attain the safe and rational use of medicines, once they are released for general use in the society. A very important outcome of pharmacovigilance is the prevention of patients being affected unnecessarily by the negative consequences of pharmacotherapy (15). In order to protect consumers from the negative consequences of drug therapy, the healthcare professionals including the Pharmacists should be aware of the concept of pharmacovigilance. Data from Nepal clearly suggest vast amount of irrational use of medicines. Some examples of the irrational use of drugs still in evidence in Nepal are: polypharmacy, use of expired drugs, the irrational fixed dose combination of drugs and overuse of antibiotics, vitamins / herbal remedies, brand prescribing, retail shop prescribing and unethical dispensing. Such irrational practices, combined with lack of patient information on proper handling and use of drugs, can lead to wastage of medicine as well as other serious consequences like adverse drug reactions and drug interactions (16). In Nepal, retail pharmacists are considered as the first point of contact for healthcare problems. However, they are often less qualified and do not have adequate sources of information and knowledge about drug related matters.

Moreover, in Nepal the pharmacy curriculum is more ‘product oriented’ and there is less emphasis on Social Pharmacy, Pharmacoepidemiology and other aspects of medicine use. The curriculum prepares the students for a job in the pharmaceutical industry than for a job in a Hospital or as a Community Pharmacist (17),(18).

We included four areas in our Pharmacovigilance training module. The first area, ‘Sketching out the current National Pharmacovigilance programme’ is very essential for the students. The students should know about the ongoing Pharmacovigilance program in Nepal. They were able to sketch out the current pharmacovigilance program. They also emphasized the need for more regional centers and peripheral centers. As of now, in Nepal there is a national centre and four regional centers.

The second area, ‘Designing an adverse drug reaction reporting form’ was well received by the students. The student designed forms had all the essential features like patient demography, drug history and drugs responsible for the ADR, contact details of the reporter, etc. In a previous session conducted for medical students, the students were creative and enjoyed the sessions (12). Similarly, the present study also clearly reflects that students liked the sessions.

The third area, ‘Carrying out the causality assessment’ using the standard method, is one of the best ways to establish the causal relationship between the drug and the effect. The Naranjo algorithm is used widely in carrying out the causality assessment of ADRs. It is based on the score calculated on the basis of the points given for each of the ten questions that comprise the table. The maximum possible score was 13. If the score was 9 or greater than 9, then the adverse reaction was categorized as ‘definitely’ caused by the particular drug. A score of 5-8 was categorized as ‘probably’ caused by the drug, while a score of 1-4 was categorized as ‘possibly’ caused by the drug.

The fourth area, ‘Carrying out the severity assessment’ is an important step in Pharmacovigilance. In order to take appropriate initiatives towards management of the ADR, it is necessary to study the severity of the ADRs. Hartwig scale is widely used for the purpose. This scale categorizes the reported adverse drug reactions into different levels as mild, moderate or severe, based on the treatment and whether or not hospitalization was required for the management of the ADRs.

The feedback of the students was positive. The students agreed that the sessions made them aware of the concept of Pharmacovigilance. With regards to the success of the current Pahrmacovigilance program in Nepal, they had a negative response. This response suggests the students’ concern regarding the program. One of the most striking findings was that the students wanted Pharmacovigilance to be incorporated in their curriculum.

While going through the feedback forms, we got some interesting responses from the student participants. One of the female respondents wrote, ‘The session was entirely new and helpful for me. It has made me feel aware of my responsibility as a Pharmacist in some way’. Another female respondent wrote, ‘This type of session must be given to the first semester students of B.Pharm and also to the general public.’ A male student wrote, ‘The information obtained during the session was very informative. Pharmacovigilance was quite a new term for me. So, it was informative for me’.

Limitations
Our study had a few limitations. It was a preliminary study and included only 30 students. Moreover, only one batch of students was included in the training program. We also did not evaluate the improvement of knowledge of the students regarding Pharmacovigilance, following the training program.

Practice Implications
To the best of our knowledge, the present study is one of the first to introduce activity-based learning of pharmacovigilance to pharmacy students in South Asia. Pharmacovigilance is an important area of practice for pharmacists. We hope our experience will be of interest to researchers and teachers from South Asia and other developing regions.

Conclusion

The study was successful in evaluating the students’ feedback on the educational sessions about pharmacovigilance. Overall, students liked the session and were interested in having similar sessions in the future. In a country like Nepal, where Pharmacy students are not taught much about the negative consequences of drug therapy, this study gains attention. This module can be taken as a model for other researchers who are willing to carry out educational sessions for pharmacovigilance for pharmacy students.

Acknowledgement

The authors acknowledge all the students who participated in the study spending their valuable time.

References

1.
Alastair J J W. Adverse Reactions to Drugs In: Braunwald etal. Harrison’s principles of Internal medicine (pp 430-438). 15th edition Mc Graw-hill, 2001.
2.
Hepler CD. Clinical pharmacy, pharmaceutical care, and the quality of drug therapy. Pharmacotherapy 2004; 24: 1491-8.
3.
van Grootheest A C, de Jong-van den Berg L T. The role of hospital and community pharmacists in pharmacovigilance. Res Social Adm Pharm 2005; 1:126-33.
4.
van Grootheest A C, van Puijenbroek E P, de Jong-van den Berg L T. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 205-10.
5.
van Grootheest, K, Olsson S , Couper M, de Jong-van den Berg L. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004; 13, 457-64.
6.
Toklu, H Z, Uysal M K. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci 2008; 30:556-62.
7.
Granas, A G, Buajordet M, Stenberg-Nilsen H, Harg P, Horn AM. Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf 2007; 16: 429-34.
8.
Green C. F, Mottram D R, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001; 51: 81-6.
9.
Cox AR, Marriott JF, Wilson KA, Ferner RE. Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes. J Clin Pharm Ther 2004; 29: 31-5.
10.
Nepal joins programme. Uppsala reports. 2007; 36: 5-6. (Available on http://www.who-umc.org/graphics/10205.pdf)
11.
Shankar PR. Pharmacology at the Manipal College Of Medical Sciences, Pokhara, Nepal : new roles and new challenges. The Internet Journal of Pharmacology, 2006 , 4.
12.
Shankar PR, Subish P. Designing a spontaneous adverse drug reaction reporting form: an exercise for medical students. The International Journal of Risk and Safety in Medicine 2006; 18: 115 –9.
13.
Naranjo CA, Busto U, Sellers EM. et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239- 45.
14.
Hartwig SC, Siegel J, Schneider P J. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49: 2229- 32.
15.
Olsson S. The need for pharmacovigilance. In: Gupta SK. Pharmacology and therapeutics in the new millennium, 2001, pp.502-508. Narosa publishing house, New Delhi.
16.
Blum NL. Drug information development. A case study from Nepal, 2002 [Online]. Accessed 9th February 2008]. Available from World Wide Web www.usp.org/pdf/EN/dqi/nepalCaseStudy.pdf
17.
B.Pharm curriculum of the Kathmandu University, Kathmandu, Nepal, 2004.
18.
B.Pharm curriculum of the Pokhara University, Pokhara, Nepal, 2004.

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