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

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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"

Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018

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 Dematolgy,
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
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,
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,
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
(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)
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.
On April 2011

Important Notice

Year : 2010 | Month : August | Volume : 4 | Issue : 4 | Page : 2929 - 2935

Importance of Consumer Pharmacovigilance System In Developing Countries: A Case Of Malaysia


*(Pharm) PhD candidate, **(PhD) Professor, Discipline of Social and Administrative Pharmacy, ***(M Pharm) PhD candidate, Discipline of Social and Administrative Pharmacy

Correspondence Address :
Mohammed Ahmed Alshakka: PhD candidate, Discipline of Social and Administrative Pharmacy
School of Pharmaceutical Sciences
Universiti Sains Malaysia, 11800 Penang, Malaysia.
Phone: 0060174034332


Adverse drug reactions (ADRs) are a major cause for morbidity and mortality. The existing system for monitoring ADRs in Malaysia depends on spontaneous reporting from health professionals as a main source of information. We present here, an overview on the need for consumer reporting in Malaysia and on the advantages, disadvantages and international experiences on consumer reporting. We discuss here, how to start consumer reporting in Malaysia and its significant contribution to the existing system of drug monitoring in Malaysia. We conclude that consumer reporting should be introduced to overcome underreporting, to promote consumer rights and to increase the knowledge about the risks of medications.


Adverse drug reactions, Consumer reporting, Drug safety, Malaysia, Pharmacovigilance.

Adverse drug reactions (ADRs) can cause short-term and long-term hospitalization and mortality.(1) Despite all their benefits, evidence continues to mount that ADRs are common, but yet are often a preventable cause of illness, disability and even death. ADRs are responsible for a significant number of hospital admissions ranging from 0.3% to 11%.(2) It has been estimated that over 770,000 people are injured or die each year from adverse drug events.(3) A commonly quoted meta analysis performed in the United States indicated that ADRs were between the 4 th and 6 th most common cause of death in 1997.(4) The World Health Organization (WHO) defines an ADR as ‘any response to a drug that is noxious and unintended, and that occurs at doses which are used in humans for prophylaxis, diagnosis, or therapy, excluding failure to accomplish the intended purpose’.(5)

There are a few studies on the incidence rate of ADRs in developing countries. A prospective observational study from Iran identified that 11.8% of the patients had experienced at least one ADR.(6) In another study from Iran, it was reported that approximately 16.8% of the patients had at least one ADR and that 2.9% of the ADRs were identified as lethal.(7) Another study from South India reported the overall incidence of ADRs as 9.8%. This included 3.4% ADR related admissions and 3.7% ADRs occurring during the hospital stay.(8) A retrospective study from Riyadh, Saudi Arabia, reported 54% of the ADRs to be preventable. The prevalence per year ranged from 0.07% in 1993 to 0.003% in 1999.(9) In Nepal, the prevalence of ADR was found to be 0.86%, the male to female ratio was found to be 0.85 and 10.81% of the ADRs were considered to be severe.(10)

Pharmacovigilance is defined by the WHO as ‘the science and activities related to the detection, understanding, assessment and prevention of adverse drug reactions and any other problems which are related to drugs’.(11) This science began 40 years ago, at the time of the disaster caused by thalidomide, which resulted in embryonic malformations in thousands of children, whose mothers used the drug during pregnancy in Europe in the early sixties; where the concerns of the world rapidly evolved, topics were discussed and the interest in the safety of medicine emerged.

The WHO began its global monitoring of drugs on an international scale in the sixties. Therefore, there is a need for pharmacovigilance because the medical information which is gathered before marketing the drug is incomplete (12). Therefore, using animals to test the effects of the medicine cannot be an evidence to use it for human beings, as these tests are done with only a small number of human beings. Therefore, the effects of the medicine could only be noticed when the drug was widely used, as there were differences between countries in the incidence of drug-related problems such as genetic and ethnic problems, the food, traditions and the materials used in the local production of medicines and the use of traditional medicines.(12)

Right to the highest standard of health
The right to the highest standard of health is one of the human rights emanating from the Declaration of Alma Ata and that does not mean only that the health system must be available to all according to their needs and that it does not depend on the results, but also during the course of this process, for example, transparency and participation, equality and fairness.(13) Access to health services and information and the right to the highest attainable standard of health and health information to enhance the health of individuals and communities can achieve a degree of transparency which ensures that all key partners including the patients and the states and public and private sectors, international organizations and civil society organizations. Also, to ensure the participation of all people in issues that affect and impact on human health is the right of such participation, including participation in defining strategies, development and policy-making, implementation and accountability have been noted in the Declaration of Alma Ata. Fairness and equality are among the most basic elements of the international human rights law.(13)

The importance of ADR reporting by consumers
The existing system of ADR monitoring in many countries rely upon the spontaneous reporting of health professionals as a mean source for information. Spontaneous reporting is the most widely used method for pharmacovigilance in many countries. Despite its inherent limitations, the system provides vital information of clinical importance. These limitations include difficulties with adverse events recognition, underreporting, biases, estimation of population exposure and report quality.(14) Patients and consumers have the right to be involved, as well as the health professionals and they have to report their experiences and their suffering as a result of these adverse effects which threaten their health and their lives.(15)

The spontaneous reporting programs make use of the information written by doctors and pharmacists and when consumers are involved in the process,this can reinforce their rights and achieve justice. The consumer’s experiences and views can be used and these serve as good tools for information about ADRs.[(16),(17)] The reports of the consumers reporting about the possible harm effects of drugs were nearly over fifteen years. This report increases the amount of knowledge which reveals significant indicators of the damage done by medicines.

However, few countries currently accept patient reports; Sweden (1978), Denmark (2003), Netherlands (2004), USA (1993), Canada (2003), Australia (2003), UK (2005) and New Zealand.[(18),(19),(20)] The consumer can report directly to the medicine agencies or indirectly through consumer organizations. They are also able to submit electronic reports or paper and also telephoned reports.
The experience in the Netherlands, obtained during 3 years, showed that patient reporting can be a good source of information for drug safety monitoring and that it has qualitative and quantitative values.(15) The evaluation of the first 6 months of patient reporting of the yellow card scheme in the United Kingdom showed that there were no differences in the proportion of serious ADRs reported, as compared to the reports made by health professionals.(20)

Blenkinsopp et al. wrote a systemic review on patient reporting of suspected ADRs. The Medicines and Healthcare products Regulatory Agency (MHRA) team in the UK showed more evidences and advantages from international experience regarding patient reporting. They concluded that there was a lack of publication on the patient reporting of ADRs in the literature and that most published studies were very small.(21) The qualitative examination of patient reporting has shown that the reports were rich in terms of their description of the nature, the severity and the significance of the reactions.(21)

Authors from Sri Lanka suggested that consumer reporting is the best method for developing countries to overcome underreporting and that it could complement the existing system of reporting based on physicians and pharmacists.(22)

The importance of the Consumer Reporting
Some of the significant roles of consumer reporting are mentioned below.

1. Consumers are active players in drug safety and key stakeholders with respect to pharmacovigilance and can actively contribute through an integrated and efficient reporting system.
2. Direct reporting is an essential tool to empower the consumers and to improve their involvement in the management of their own health.
3. With consumer reporting, ADRs will be detected earlier and more number of ADRs would be reported, especially with respect to the over-the-counter (OTC) medicines.
4. Consumer reporting can be a useful method to overcome underreporting which is a common limitation of the pharmacovigilance programs.
5. Consumer reporting can be a good solution for the limitation of the existing system based on the health professional’s reports.
6. Consumer reporting will promote consumer rights.
7. Though consumer reporting cannot replace the existing system, it can complement and strengthen it.

The advantages of Involving Consumers in ADR Reporting
There are a number of benefits which are associated with the consumer reporting of ADRs. Some of them are listed below.

1. A new source of information: Consumer reporting is an important source of new information on the harmful effects of drugs that could benefit the regulatory authorities of the drugs and it is also an important source of information in clinical practice.[(21),(23)]
2. Disclosure of the effects which previously unknown:When consumer reporting started in Denmark in 2003 in the first year, there were 149 reports from the patients, which represented 7% of all the reports. One-third of these effects included unknown adverse reactions.[(17),(23)]
3. Early reports than health professionals: A study in the Netherlands suggested that patients recognize and report adverse effects more quickly and early than the health workers.[21-23]
4. Increase of the number of reports: The United States began consumer reporting in 1993. In 2004, the reports of the patients from the 24,553 reports were found to be 15%.
5. Quality of Life: After analysis of the data by the pharmacovigilance centre in Sweden, it was revealed that the style of the reports of the patients was different from that of the doctors, who provided more information on the impact of medicine on the quality of lives, more than those who worked in the health affairs.(21)
6. The reporting of serious adverse effects: The Center of Pharmacovigilance in the Netherlands noted that the reports of patients provided information on the serious adverse effects of drugs.
7. Different style, but with the same quality: The patients do not use the expressions which are used by the doctors and the pharmacists. Therefore, the authorities noted that it was difficult to assess the reports and that it required more time.(23) Also, there was no information about the time taken for the analysis of these data. Also, some authors raised concerns about the quality of the reports and their credibility. But, the Netherlands Pharmacovigilance Centre pointed out that the patient’s reports had the same amount of information as provided by health workers.[19-23]
8. Reports of elder people: A group of Belgian authors compared between patients and health workers at the same period of time where the pharmacists asked 168 elderly patients. The authors asked the patients to explain the reasons for hospital admissions. The patients reported about 33 effects, while only 12 reports out of the 33 reports were provided. The doctors reported serious adverse effects, while the patients reported some effects that forced them to stay in the hospital.[(21),(23)]

International Experiences on the Consumer Reporting of ADRs
Mainly, the western counties and Australia are successful in incorporating consumers in their ADR monitoring programs. A brief outline on the system in these countries is mentioned below.

1. Sweden: The Consumer Association for Medicines and Health (KILEN) started its activities on consumer reporting since 1978. The experience in KILEN showed that the patients can report different things in different ways and sometimes in far greater volumes than the professionals. For example, during 1984-1988, Kilen received 420 reports about lorazpam, while in the period between 19801988, the processional’s reports totaled to only 18. A comparison of 327 consumer reports and 437 physician reports for straline showed that there were many side effects as reported in great numbers by the consumers.[[16-18],(21)]
2. Netherlands: The national pharmacovigilance centre received reports from consumers since 2003. After the first one year, it was found that the reports from the patients usually contained sufficient medical information and they referred more frequently to serious adverse drug reactions than that reported by the health professionals.[[16-18],(21)]
3. United Kingdom: The MHRA started a pilot study in 2003. The British yellow card scheme allowed patients to report directly to MAHRA in January 2005. Patients could submit the reporting form or electronic reports. The evaluation of the yellow card scheme in the first 6 months of patient reporting in the United Kingdom showed that there were no differences in the proportion of the serious ADRs reported, as compared with the reports of the health professionals.(20) After one year of online reporting by the consumers, more than 2,500 yellow cards were filled by the patients or their caretakers, bringing the total number of the patient reports to almost 9,000. The information collected over one year form online reporting has contributed to the advice of the agency on issues like Varenidine (Champix), adverse psychiatric reactions which are associated with Rimonabant (Acomplia) and the withdrawal of its license due to psychiatric risks.(24)
4. Denmark: The Danish Medicines Agency set up a patients’ reporting system in July 2003, in part, as a response to pressure organised by the Danish Consumers Council after its own research on the anti-obesity drug, Letigen showed a greater level of adverse reactions than those reported by the professionals alone. As in the United Kingdom, efforts to promote to consumers the possibility to report are limited; a leaflet produced by the agency was not widely available. Again, like the United Kingdom, the form which patients had to fill, was an adaptation of that which was already used by the professionals and it employed medical terminology which was not clear to a lay reporter.(18)
5. Belgium: Test-Achats is a member of the European consumer’s organization which was started in November 2006, which was an initiative on patients reporting in collaboration with the Belgian Agency of Medicines (FAGG). The Test-Achats experts' team (pharmacists and medical doctors) sends the report to the pharmacovigilance department of the medicines agency. Within a month, the agency sends the evaluation back to Test-Achats who provides a feedback to the consumer. From November 2006 to December 2007, 184 ADRs were reported. Test-Achats also registered 56 reports of other drug related problems and received 31 questions regarding the prices and the reimbursement of the medicines and 15 questions regarding the patient information leaflets.(25)
6. Italy: Altroconsumo, a member of the European consumers organization, launched in June 2006 on its web site, the initiative “Questa la racconto” (I tell you my story), to collect consumers’ experiences of adverse reactions following the use of some specific medicines. In the beginning, they did it for two creams which were used to treat eczema and then they expanded it to coxib and to glitazones which were used to treat diabetes. In one year, they received 230 reports. The reports were sent to AIFA, the Italian medicines agency. This initiative showed that consumers’ reports are essential, not only to know more about adverse drug reactions, but also to know when the medicines are not used appropriately. For example, in the case of the two creams for eczema, Altroconsumo showed that they were prescribed for age not authorized, as first option treatment and not as second option treatment as required from the competent authorities and for longer period of time than suggested.(25)
7. United States: MedWatch, the Food and Drug Administration (FDA)’s Safety Information and Adverse Event Reporting Program, offers patients some scope to directly report adverse drug reactions. However, the majority of reports originating from patients that actually reach the FDA are sent in by the pharmaceutical industry. This sector has the legal obligation to pass on all the reports that it receives. Thus, questions and complaints from patients concerning drugs which are addressed to the marketing authorisation holder are categorized as patient reports. A mere 9% of all the reports that the FDA receives have been directly submitted by physicians, pharmacists or health consumers. Approximately 40% of all the reports stem from patients. There are no publications yet, on the contribution of consumer reports to the FDA.
8. Australia: Since the early 1990s, Australia has been taking its first steps towards creating facilities to allow patients to report their complaints on drugs. The Australian Patient Safety Foundation runs and maintains the Australian Incident Monitoring System (AIMS). However, only 20% of the reports concern medication and only 4% of these are about adverse events. The national reporting system (ADRAC) receives about 10, 000 reports per year and this includes all appropriately documented patient reports. On an annual basis, the latter comprises fewer than 100 reports.

The current Pharmacovigilance Program in Malaysia
Malaysia has a national centre of Pharmacovigilance, namely, the ‘National Adverse Drug Reaction Monitoring Centre’, that covers the country overall. Some major hospitals and pharmaceutical companies also operate ADR monitoring systems, but all reports are consolidated by the national centre. The reports from doctors, pharmacists and dentists are collected on a voluntary basis, but the reports from marketing authorization holders are mandatory. They monitor drugs for human use, vaccines, biologicals and herbal remedies. The National ADR centre uses prepaid postage report forms or updated report cards every month. They still maintain records manually. They have a local database. The national centre has an advisory committee which makes the causality assessment of the reported ADRs. The Malaysian Adverse Drug Reaction Advisory Committee (MADRAC) was established under the Drug Control Authority (DCA) to perform the function of monitoring the safety profiles of the drugs which were registered for use in Malaysia. MADRAC provides the DCA with the information pertaining to drug safety issues which occur locally and internationally. The National Drug Safety Monitoring Centre, which is the secretariat to MADRAC, was accepted as the 30th member of the WHO Safety Monitoring Program in 1990. Under the monitoring programme, all ADR reports which have been received and screened by MADRAC, are submitted to the Uppsala Monitoring Centre in Sweden for inclusion into the WHO database.[(26),(27)]
The MADRAC also promotes ADR reporting in Malaysia and provides information and advice to the DCA so that regulatory action can be taken, based on the ADRs received (local and foreign). It also provides information to doctors, pharmacists and other health care professionals on the ADRs and participates in the WHO ADR monitoring programme.

For the year 2007, the National Centre for Adverse Drug Reactions Monitoring received a total of 3068 spontaneous reports of suspected ADRs. This was an increase of 525 reports (20.6%) over the 2543 reports received for 2006. During the course of the year 2007, a combination of pharmacists and dentists submitted the most number of ADR reports, which was 41.8% of the total number of ADR reports which were received. It was an increase of 76.7% as compared to those received in the year 2006. However, the number of government doctors reporting ADRs decreased by 15.6% as compared to the year 2007. The ADR reports were mainly related to respiratory system disorders such as coughing/dry cough. The other suspected drugs among the top ten which contributed to the most number of ADR reports, were allopurinol, cloxacillin, diclofenac, metformin, aspirin, ticlopidine, rifampicin, phenytoin and amoxycillin.(28)

The centre also makes recommendations to the drug control authority on the labeling changes, the restriction on the use and suspension or withdrawal of drugs from market, the assessment of the signals run by the manual screening for potential signals, the local data base, the WHO data base and medical literature which are examined and brought up for discussion with the advisory committee, which convenes six times a year and it is a subcommittee to the drug control authority in Malaysia.[(26),(27)]

The need for a Consumer Reporting Program in Malaysia
Consumer reporting of ADRs can improve pharmacovigilance in Malaysia for these following reasons:
1. Greater amounts of information and awareness will raise and avoid pain and suffering and will prevent economic loss.
2. The numbers of reports given by the doctors, pharmacists and dentists is still small (25) and so, the consumer will be a rich source of useful information on the harmful effects of drugs and this program can lead to an increase in such reports.
3. Limitations of the existing reporting system: Worldwide, only a small number (less than 5%) of the doctors, pharmacists and dentists make reports. A number of doctors are reluctant to make such reports for fear of legal liability, or the indictment of bad practice.(27)
4. A study conducted in Malaysia to assess the causes of underreporting about ADRs revealed that 81.4% of the doctors suspected ADRs but did not report them, while 40% of the respondents were not aware that there was a system for monitoring the harmful effects of drugs in Malaysia and the lack of awareness and understanding of the functions and the purpose of this national program.(29)
5. There are a large number of people using traditional drugs without reference to the doctor, or the consequences of failing to report them, as well as a very small number of reports on the harmful effects of traditional medicines which are submitted to the national drug monitoring centre in Malaysia.
6. Consumer reporting can cover situations about which the physician is not informed and about which he therefore cannot report.
7. Consumer reporting can promote consumer rights and equity.(30)
8. Consumers can provide unique perspectives and experiences.(30)
9. Consumers can provide information and insight which are crucial to establish effective and safe drug use.

The medical establishment can profit from the discipline of consumer input. Consumers for this part, need a willing ear and channel through which they can make their experiences and feelings known, as they assume the risks and costs of the existing medicines. They are also exposed to the relationship between the benefits, harm and costs of drug use and can contribute to the knowledge of that relationship.(28)
An Approach to Start a ConsumerReporting Program in Malaysia?
The establishment of a pharmacovigilance centre can start very quickly. This process needs time, vision, dedication, expertise and continuity.(31) The centre must have a strong relationship with drug regulation. It needs good collaboration, coordination, communication and public relations for its development. Any department under the health authority, in hospitals or in an academic environment can be a good host to establish such a centre.(31)

Contribution of Consumer Reporting to the Existing Pharmacovigilance Program
Consumer reporting cannot replace the existing pharmacovigilance program, but it can complement and strengthen it. Consumer reporting provides qualitative and quantitative contribution to the existing system which is available in the country. Consumer reporting as a new concept, will enhance the impact of the reporting system and can improve the knowledge about the ADRs of over –the- counter medicines, the off-label use of medications, traditional medicines and alternative medicines about whose risks doctors may be not familiar enough.


Evidence from developed countries has clearly revealed the benefit of involving consumers in pharmacovigilance programs. After 20 years of pharmacovigilance in Malaysia, there is a need of the consumer reporting of suspected ADRs to be introduced to improve the existing pharmacovigilance system. Consumer reporting of suspected ADRs can add many benefits to the available drug monitoring system, overcome under reporting, promote consumer rights, improve the public quality of life and can be an important information source for clinical practice.


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