|Year : 2012 | Volume
| Issue : 3 | Page : 90-94
Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting
Mala Kharkar1, Suresh Bowalekar2
1 Vice Principal , Patkar and Varde College, B2 12, Mahindra Gardens, S.V.Road, Goregaon(west) Mumbai, India
2 Managing Director, Pharmanet Clinical services Pvt. Ltd., Marwah Centre, 7th Floor, Krishnalal Marwah Marg, Andheri (East), Mumbai, India
|Date of Web Publication||5-Sep-2012|
Vice Principal , Patkar and Varde College, B2 12, Mahindra Gardens, S.V.Road, Goregaon (west) Mumbai - 400 062
| Abstract|| |
Objective: The objective was to assess knowledge, attitude and perceptions/practices (KAP) of medical practitioners (MPs) in India towards Adverse Drug Reaction (ADR) reporting. Materials and Methods: A questionnaire was designed for assessment of KAP of medical practitioners in India toward ADR reporting. This questionnaire was administered to 2-3 medical practitioners from each zone prior to administering final questionnaire which was approved by Disha Independent Ethics Committee, Mumbai. 1200 medical practitioners (about 300 from each zone) from India were selected randomly. Results: 1000 medical practitioners out of 1200 (90%), selected at random were approached. A total of 870 provided responses to the questionnaire, giving a response rate of 73% of 1200 selected randomly. A total of 47.5% respondents reported that they were aware of Government ADR centers. A total of 59.2% reported that they are familiar with the procedure of reporting ADRs to Government centers. However, only 18.5% of MPs have reported the observed ADRs to Government ADR centers. As against this relatively large number of MPs (87.9%) have reported ADRs observed during their routine practice to medical representatives of pharmaceutical company and NGOs (non-Govt. Organizations). A total of 80.5% of respondents agreed that safety plays an important role and 96% reported that ADR centers are useful. However, only 55.6% of respondents have reported that there is a need for ADR centers. Conclusion: The study reveals that practitioners are aware of ADR reporting; their perception toward ADR reporting is right but it is not reflected when it comes to the act of reporting of ADRs. In our sample of 870 respondents only 18.5 % reported ADRs to some organizations. Only 5% of respondents recorded the details of ADR and reported to the manufacturer and 1% of respondents to government health ministry. Thus, medical practitioners in India appear to have a good knowledge about ADR reporting, the right perception toward ADR reporting. However, as far as practice of ADR reporting is concerned it is discouraging.
Keywords: Adverse drug reactions, ADR reporting, pharmacovigilance
|How to cite this article:|
Kharkar M, Bowalekar S. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting. Perspect Clin Res 2012;3:90-4
|How to cite this URL:|
Kharkar M, Bowalekar S. Knowledge, attitude and perception/practices (KAP) of medical practitioners in India towards adverse drug reaction (ADR) reporting. Perspect Clin Res [serial online] 2012 [cited 2013 Jun 18];3:90-4. Available from: http://www.picronline.org/text.asp?2012/3/3/90/100651
| Introduction|| |
Any drug/medicine during its normal therapeutic use has a potential to produce adverse reaction(s). It is very difficult to get any medicine which is absolutely safe. Adverse drug reactions (ADRs) contribute to a significant number of morbidity and mortality all over the world.  It is known that the primary goal of medicines prescribed by the physicians, dispensed by the pharmacists, and consumed by the patients, is individual benefit of the patient with minimum risk leading to overall improvement in the public health. In the current scenario, the adverse consequences of the drug are detected in the early stage of drug development. However, this process has limitations, even in well-designed clinical trials. This is because of many factors such as number of patients studied, duration of treatment, dosage schedule, and use of drug in specially selected population. Thus, safety evaluation can only be possible with long-term use of drug in clinical practice. Since ADRs remain an important cause of morbidity and mortality, there is a need for continuous pharmacovigilance for all medicines -- even those that have been available for many years.
All new drugs are required to provide intended therapeutic effect and thus prove to be efficacious as well as safe. Based on the risk-benefit analysis, regulatory approvals are granted. This ensures availability of legally approved drug product in the country and exposure to thousands of patients at one point of time. Physicians prescribe medicine under the assumption that each medicine/drug product enters the market only after (i) carrying out rigorous quality control tests, and (ii) ensuring clinical efficacy and safety of the product. However, new adverse effects are discovered only after the drug product gets exposed to a wider population. Despite various benchmarks of quality, efficacy, and safety even in the most developed countries like USA, there have been instances where blockbuster drugs had to be withdrawn from the market within few years of their launch (e.g., Cerivastatin, Cisapride, COX-II inhibitors like Rofecoxib, Valdecoxib, etc.). This highlights the importance of spontaneous reporting of adverse drug reactions of all the drugs, whether they are new or old.
Many developed countries have strong pharmacovigilance systems.  The systems are established to report suspected ADRs that medical practitioners encounter in their clinical practice. However, there are considerable differences in the patterns of ADR reporting phenomena. A serious limitation with all ADR reporting methods all over the world is an under reporting. Even in high-rated ADR reporting countries, merely 10% of the total ADRs are seen to be reported. ,, Accumulated evidence suggests that there are so many factors that determine the rate of ADR reporting. Therefore, it is very important to assess knowledge, attitudes, and perceptions / practices of medical practitioners toward ADR reporting.
Despite the efforts of the Drug Controller General of India (DCGI) and Indian Council of Medical Research (ICMR) in establishing ADR monitoring centers in many hospitals in the major cities of India and the presence of a large number of tertiary care facilities, pharmacovigilance is still in its infancy in India. Gross underreporting of ADR is a cause of concern, the reasons for which may be many. 
Hence, this study was designed to assess the three quotients - knowledge (K), attitude (A), and perceptions/practices (P) in a fairly representative sample of medical practitioners in India.
The objectives of our study were as follows:
- To assess knowledge, attitude, perception/practices (KAP) of medical practitioners toward ADR reporting.
- To identify causes for any deficiency in knowledge, attitude, and perceptions/practices and to see whether the system needs any further improvement.
| Materials and Methods|| |
A draft questionnaire was pretested by administering it to 10 medical practitioners from four zones (North - 2, East - 2, West - 3, and South - 3) of India. Based on the comments and suggestions of 10 medical practitioners a final questionnaire was finally prepared for conducting the survey. Thus, our study was a questionnaire-based survey conducted among all categories of medical practitioners. The final questionnaire was approved by Disha Independent Ethics Committee, Mumbai. The initial list of about 1600 doctors who were regularly followed up by the field staff or medical representatives was obtained by authors from their respective contacts in pharmaceutical industry. From this list, about 1600 doctors (400 from each of the four zones - North. East, West, and South) were selected randomly. Repeat names in this list of 1600 doctors were identified and removed from the list. Thus a final list of 1365 unique doctors was generated. It was observed that these 1365 doctors were not uniformly distributed over four zones. Hence, the sample size was further restricted to 1200 with a distributions and 300 from each Zone by randomly removing some names of doctors from each zone. Thus a random sample of 1200 medical practitioners with a distribution of 300 (approx.) from each of the four zones of the country was selected for inclusion in the survey.
About 4-5 medical practitioners from each zone were personally contacted with prior appointment and were requested to complete questionnaire during the personal contact. The rest questionnaires were sent to remaining medical practitioners from each zone. From each zone some medical practitioners volunteered to follow-up other medical practitioners in and around their place in respective zones and get the questionnaire completed from them. Most of the doctors in the west zone (mainly Maharashtra and Gujarat) and in the south zone (mainly Bengaluru, Hyderabad, and Mysore) were personally contacted by one of the authors.
| Results|| |
A list of about 1200 randomly selected medical practitioners for the survey was prepared for inclusions in to the survey. Only 1000 of 1200 (83%) could be contacted. A total of 870 of 1000 (87%) MPs contacted provided response to the questionnaire. The response rate with respect to 1200 finally selected medical practitioners was 73%. The responses from 870 practitioners were used for further statistical analysis.
The demographic profile of 870 respondents is presented in [Table 1].
It can be seen from [Table 1] that the mean age of the respondents is 43 years.
[Table 2] gives the distribution of respondents by specialty (branch of medicine).
It reveals that general practitioners (35%) and those practicing general medicine (34%) together accounted for 69%. The rest 31% were from various fields which included dermatology, orthopedics, pediatrics, gynecology, ophthalmology, ENT, and others.
Responses by medical practitioners to questions related to knowledge or awareness about ADR reporting are summarized in [Table 3].
As far as awareness of Government or private ADR centers are concerned, the [Table 3] reveals that 47.5% of the respondents were aware of government ADR centers and almost the same number of medical practitioners (47.7%) were aware of private ADR centers. However, 59.2% of respondents claimed that they are familiar with the procedure of ADR reporting. The explanation of this anomaly was subsequently clarified by respondents who reported as familiar with procedure but not aware of ADR centers as they reported the ADRs as per the procedure shared with them by seniors without realizing that it was for any entity known as ADR centers.
[Table 3] further reveals that about 39% practitioners observed ADRs in patients under their care. Only 19% of practitioners reported these ADRs to ADR centers. As against this, 89.7% practitioners reported observed ADRs to either medical representatives or Drugs Controller General of India (DCGI), NGOs or others. About 58% happen to have heard about postmarketing surveillance (PMS) studies. About 69% reported that they have conducted clinical trials including phase IV and PMS studies.
The fact that only 18.5% of responders have reported ADRs to ADR centers shows that the ADRs are always underreported. Only 1.6% of respondents found to be aware of "under-reporting" of ADRs in the other countries.
[Table 4] provides summaries on different ways practitioners used to handle or treat ADRs.
The practitioners provide various kinds of advices to patient like stopping the medicine, prescribing other medicine, or telling patients not to worry of the ADR as it is well known. However, only 5% of respondents reported that they recorded the details of ADR and reported to the manufacturer and 1% of respondents to government health ministry.
[Table 5] summarizes the perception of responders toward ADR reporting.
As can be seen from [Table 5], 57% of the respondents reported that there is a need for ADR centers in different parts of the country. A total of 96% of practitioners have perception that ADR centers either Government or and private, are very useful. In spite of the above favorable perceptions in terms of need and usefulness of ADR centers, the percentage of practitioners reporting ADRs to ADR centers has been very low (18.5%) as described earlier in [Table 3].
[Table 6] gives list of various suggestions given by the respondents.
[Table 6] reveals that there are various suggestions from respondents. Major suggestions are making provision of electronic option for submission of ADR reports (30%) and educate and create awareness on ADR reporting (20%). A total of 11% suggested that the procedure to submit the report should be made easier. The easier way according respondents could be electronic submission or provision of toll free number. A total of 9% suggested that financial compensation be provided to clinicians to improve ADR reporting.
| Discussions|| |
Under-reporting of ADRs is an universal phenomenon and is attributed to inherent weakness of adverse reaction particularly with the current voluntary reporting schemes. About seven million patients were exposed to fenfluramine before the association with valvular heart disease led to its withdrawal from market.  This prompted us to check if the under-reporting was due to any other reasons besides the voluntary reporting scheme. In the literature, we found many surveys on knowledge, attitude, and perceptions/practices of medical practitioners. However, such surveys were conducted using relatively small number of subjects and/or were limited to a specific region/area or using specific population of respondents. We thought of conducting this survey on all-India basis by selecting a representative sample of relatively large number of medical practitioners selected from four different zones - North, East, West, and South. The purpose of the questionnaire, like other surveys, was basically to identify the factors, if any, responsible for underestimation of ADRs. In addition we also tried to cull out the information on number of voluntarily reported ADRs to authorities, and/or other related organizations like (nongovernment organizations) and manufacturing companies.
Our findings, like previously published results of earlier surveys, suggest that there is a reasonable amount of knowledge or awareness in the medical practitioners about importance of ADRs and also majority perceive that Government or private ADR centers are very useful, yet in practice there is lot of lethargy toward reporting of ADRs. To be specific, our findings are in agreement with Madhan Ramesh  who had similar observations and suggestion in a survey of about 100 medical Practitioners. Rehan HS  in a survey of 107 fifth semester MB,BS undergraduate students and 117 prescribers found that the knowledge, attitude, and practices of both undergraduates and prescribers comparable yet need further improvement. They concluded that there is a need for suitable changes in the undergraduate teaching curriculum and also that prescribers need a periodic reinforcement regarding ADR monitoring. Suparna Chatterjee  in a survey of 138 clinicians from East India has more or less same kind of findings. According to this study there exists a good knowledge about ADR reporting among clinicians. However, the two quotients - attitude and perception/practice are still gray zones amongst the clinicians. She also found that there is a need to create awareness about drug safety and pharmacovigilance by incorporating it in medical teaching and training curriculum.
Pushkin R  listed many possible reasons for physicians not reporting ADRs. Main reasons reported are possibility of physicians being uncertain about association between an ADR and drug and physicians' perception that others in the hospital like pharmacists report such events to authorities.
In an attitudinal survey conducted by Eland  it is reported that over 35% of medical practitioners in Netherlands were of the opinion that reporting of ADRs takes too much time and that it is too bureaucratic. They also reported other reasons for not reporting ADRs as lack of knowledge like not knowing how to report, not knowing which ADRs to report, and even unawareness of the existence of a reporting scheme.
In addition to MPs we have conducted survey of patients, majority of them being those who attended the clinics of these respective MPs with a view to gather data which will be used to investigate if there is any association between some of these parameters and percentage under-reporting, and if possible to fit a statistical model, in future, to estimate the extend of under-reporting of ADRs.
| Conclusion|| |
Analysis of data generated in our survey revealed that the knowledge about ADR reporting exists among medical practitioners in addition to the right perception toward ADR reporting. However the practice of ADR reporting is discouraging. For some reasons the act of reporting ADRs to appropriate authorities is not up to the mark leading to under reporting of ADRs in this country.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]