Original Article

Mala Kharkar,
Suresh Bowalekar1 Knowledge, attitude and perception/
Vice Principal , Patkar and Varde
College, B2‑12, Mahindra Gardens,
practices (KAP) of medical practitioners
S.V.Road, Goregaon(west) Mumbai,
1
Managing Director, Pharmanet in India towards adverse drug reaction
Clinical services Pvt. Ltd., Marwah
Centre, 7th Floor, Krishnalal Marwah
Marg, Andheri (East), Mumbai, India (ADR) reporting
Address for correspondence:
Mrs. Mala Kharkar,
Vice Principal , Patkar and Varde
College, B2‑12, Mahindra Gardens,
S.V.Road, Goregaon (west)
Mumbai - 400 062, India.
E-mail: mala_kharkar@yahoo.com

Abstr ac t 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.
Key words: Adverse drug reactions, ADR reporting, pharmacovigilance

Access this article online INTRODUCTION

Quick Response Code:
Website:
Any drug/medicine during its normal therapeutic use has a
www.picronline.org
potential to produce adverse reaction(s). It is very difficult
DOI: to get any medicine which is absolutely safe. Adverse drug
10.4103/2229-3485.100651 reactions (ADRs) contribute to a significant number of
morbidity and mortality all over the world.[1] It is known that

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 Kharkar and Bowalekar: KAP of Indian medical practitioners towards ADR reporting

the primary goal of medicines prescribed by the physicians, large number of tertiary care facilities, pharmacovigilance is
dispensed by the pharmacists, and consumed by the still in its infancy in India. Gross underreporting of ADR is
patients, is individual benefit of the patient with minimum a cause of concern, the reasons for which may be many.[5]
risk leading to overall improvement in the public health.
In the current scenario, the adverse consequences of the Hence, this study was designed to assess the three quotients –
drug are detected in the early stage of drug development. knowledge (K), attitude (A), and perceptions/practices (P)
However, this process has limitations, even in well‑designed in a fairly representative sample of medical practitioners
clinical trials. This is because of many factors such as in India.
number of patients studied, duration of treatment, dosage
Objective
schedule, and use of drug in specially selected population.
Thus, safety evaluation can only be possible with long‑term The objectives of our study were as follows:
use of drug in clinical practice. Since ADRs remain an • To assess knowledge, attitude, perception/practices
important cause of morbidity and mortality, there is a need (KAP) of medical practitioners toward ADR reporting.
for continuous pharmacovigilance for all medicines ‑‑ even • To identify causes for any deficiency in knowledge,
those that have been available for many years. attitude, and perceptions/practices and to see whether
the system needs any further improvement.
All new drugs are required to provide intended therapeutic
effect and thus prove to be efficacious as well as safe. MATERIALS AND METHODS
Based on the risk‑benefit analysis, regulatory approvals
are granted. This ensures availability of legally approved A draft questionnaire was pretested by administering it
drug product in the country and exposure to thousands of to 10 medical practitioners from four zones (North ‑ 2,
patients at one point of time. Physicians prescribe medicine East ‑ 2, West ‑ 3, and South ‑ 3) of India. Based on the
under the assumption that each medicine/drug product comments and suggestions of 10 medical practitioners a
enters the market only after (i) carrying out rigorous final questionnaire was finally prepared for conducting
quality control tests, and (ii) ensuring clinical efficacy and the survey. Thus, our study was a questionnaire‑based
safety of the product. However, new adverse effects are survey conducted among all categories of medical
discovered only after the drug product gets exposed to a practitioners. The final questionnaire was approved by
wider population. Despite various benchmarks of quality, Disha Independent Ethics Committee, Mumbai. The
efficacy, and safety even in the most developed countries initial list of about 1600 doctors who were regularly
like USA, there have been instances where blockbuster followed up by the field staff or medical representatives
drugs had to be withdrawn from the market within few was obtained by authors from their respective contacts in
years of their launch (e.g., Cerivastatin, Cisapride, COX‑II pharmaceutical industry. From this list, about 1600 doctors
inhibitors like Rofecoxib, Valdecoxib, etc.). This highlights (400 from each of the four zones – North. East, West, and
the importance of spontaneous reporting of adverse drug South) were selected randomly. Repeat names in this list
reactions of all the drugs, whether they are new or old. of 1600 doctors were identified and removed from the list.
Thus a final list of 1365 unique doctors was generated. It
Many developed countries have strong pharmacovigilance was observed that these 1365 doctors were not uniformly
systems.[2] The systems are established to report suspected distributed over four zones. Hence, the sample size was
ADRs that medical practitioners encounter in their clinical further restricted to 1200 with a distributions and 300 from
practice. However, there are considerable differences in each Zone by randomly removing some names of doctors
the patterns of ADR reporting phenomena. A serious from each zone. Thus a random sample of 1200 medical
limitation with all ADR reporting methods all over the practitioners with a distribution of 300 (approx.) from
world is an under reporting. Even in high‑rated ADR each of the four zones of the country was selected for
reporting countries, merely 10% of the total ADRs are inclusion in the survey.
seen to be reported.[1,3,4] Accumulated evidence suggests
that there are so many factors that determine the rate of About 4‑5 medical practitioners from each zone were
ADR reporting. Therefore, it is very important to assess personally contacted with prior appointment and were
knowledge, attitudes, and perceptions / practices of requested to complete questionnaire during the personal
medical practitioners toward ADR reporting. contact. The rest questionnaires were sent to remaining
medical practitioners from each zone. From each zone
Despite the efforts of the Drug Controller General of some medical practitioners volunteered to follow‑up other
India (DCGI) and Indian Council of Medical Research medical practitioners in and around their place in respective
(ICMR) in establishing ADR monitoring centers in many zones and get the questionnaire completed from them.
hospitals in the major cities of India and the presence of a Most of the doctors in the west zone (mainly Maharashtra

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 Kharkar and Bowalekar: KAP of Indian medical practitioners towards ADR reporting

and Gujarat) and in the south zone (mainly Bengaluru, Table 1: Demographic profile of respondents
Hyderabad, and Mysore) were personally contacted by Total number of medical practitioners
one of the authors. Randomly selected 1200 (100%)
Approached 1000 (83%)
Responded 870 (73%)
RESULTS Age (years)
Mean 43.2
Standard deviation 9.00
A list of about 1200 randomly selected medical practitioners Range (Min–Max) 23–75
for the survey was prepared for inclusions in to the survey. Sex
Only 1000 of 1200 (83%) could be contacted. A total of Males 477 (55%)
Females 393 (45%)
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 Table 2: Distribution of medical practitioners by
responses from 870 practitioners were used for further specialty
statistical analysis. Specialty No of medical Percentage
practitioners
The demographic profile of 870 respondents is presented General practitioner 307 35.28
in Table 1. General medicine 297 34.13
General surgery 170 19.55
Dermatology 13 1.49
It can be seen from Table 1 that the mean age of the
Orthopedics 12 1.37
respondents is 43 years. Pediatrics 16 1.84
Obstetrics and gynecology 14 1.61
Table 2 gives the distribution of respondents by specialty Anesthesiology 9 1.05
(branch of medicine). Ophthalmology 4 0.46
ENT (ear, nose, and throat) 4 0.46
Others 24 2.76
It reveals that general practitioners (35%) and those Total 870 100
practicing general medicine (34%) together accounted
for 69%. The rest 31% were from various fields which
included dermatology, orthopedics, pediatrics, gynecology, Table 3: Knowledge/awareness parameters
ophthalmology, ENT, and others. Knowledge/awareness/attitude Yes No Percentages
parameters of “Yes”

Responses by medical practitioners to questions related Aware of government ADR centers 413 457 47.5
Aware of ADR centers (other than Govt.) 415 455 47.7
to knowledge or awareness about ADR reporting are Heard about postmarketing surveillance 503 367 57.8
summarized in Table 3. studies (PMS)
Reported ADRs to MR, DCGI, NGOs, 765 105 87.9
As far as awareness of Government or private ADR and others
Familiarity with procedure of reporting 515 355 59.2
centers are concerned, the Table 3 reveals that 47.5% of ADR
the respondents were aware of government ADR centers Observed ADRs in patients under care 337 533 38.7
and almost the same number of medical practitioners Reported observed ADRs to ADR 161 709 18.5
centers in past
(47.7%) were aware of private ADR centers. However, Aware of underreporting of ADRs in 14 856 1.6
59.2% of respondents claimed that they are familiar with other countries
the procedure of ADR reporting. The explanation of this Conducted clinical trials (includes phase 602 268 69.1
anomaly was subsequently clarified by respondents who IV and PMS) in India
reported as familiar with procedure but not aware of ADR
centers as they reported the ADRs as per the procedure About 69% reported that they have conducted clinical trials
shared with them by seniors without realizing that it was including phase IV and PMS studies.
for any entity known as ADR centers.
The fact that only 18.5% of responders have reported
Table 3 further reveals that about 39% practitioners ADRs to ADR centers shows that the ADRs are always
observed ADRs in patients under their care. Only 19% underreported. Only 1.6% of respondents found to
of practitioners reported these ADRs to ADR centers. As be aware of “under‑reporting” of ADRs in the other
against this, 89.7% practitioners reported observed ADRs to countries.
either medical representatives or Drugs Controller General
of India (DCGI), NGOs or others. About 58% happen to Table 4 provides summaries on different ways practitioners
have heard about postmarketing surveillance (PMS) studies. used to handle or treat ADRs.

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 Kharkar and Bowalekar: KAP of Indian medical practitioners towards ADR reporting

The practitioners provide various kinds of advices to patient Table 4: Advice/action on reported side effects
like stopping the medicine, prescribing other medicine, or Advice/action No. of medical Percentage
telling patients not to worry of the ADR as it is well known. practitioners
However, only 5% of respondents reported that they recorded Prescribe appropriate medicine to 484 57
the details of ADR and reported to the manufacturer and 1% control the side effect
of respondents to government health ministry. If the side effect is well known for 176 20
medicine, tell the patient not to
worry
Table 5 summarizes the perception of responders toward Stop the medicine 55 6
ADR reporting. Recorded all details and reported 40 5
to the manufacturer of medicine
As can be seen from Table 5, 57% of the respondents reported Recorded all details and reported 13 1
to Government Health Ministry
that there is a need for ADR centers in different parts of the Used multiple actions in different 102 11
country. A total of 96% of practitioners have perception that combinations
ADR centers either Government or and private, are very Total 870 100
useful. In spite of the above favorable perceptions in terms
of need and usefulness of ADR centers, the percentage of Table 5: Perception/practice parameters
practitioners reporting ADRs to ADR centers has been very Perception/practice parameters Yes No Percentage
low (18.5%) as described earlier in Table 3. Yes (%)
Need for ADR centers 484 386 57
Table 6 gives list of various suggestions given by the Reported safety related issues to 103 767 12
respondents. Government ADR centers
Govt. ADR centers are useful 835# 35 96
Privately run ADR centers are useful 838# 32 96
Table 6 reveals that there are various suggestions from Safety information play an important 700 170 80
respondents. Major suggestions are making provision of role
electronic option for submission of ADR reports (30%) All unwanted events attributable to 34 836 4
and educate and create awareness on ADR reporting medicine
Underreporting of ADRs in India 701 169 80
(20%). A total of 11% suggested that the procedure to Underreporting of ADRs in other 14 856 2
submit the report should be made easier. The easier way countries
according respondents could be electronic submission or #Response categories “very much” and “somewhat” clubbed as “Yes.”
provision of toll free number. A total of 9% suggested
that financial compensation be provided to clinicians to
Table 6: Suggestions to improve ADR reporting
improve ADR reporting.
Suggestions No. of doctors Percentage
Make it easier to submit reports 99 11
DISCUSSIONS Provide financial compensation to 77 9
submit reports
Education/increase awareness of 174 20
Under‑reporting of ADRs is an universal phenomenon reporting system
and is attributed to inherent weakness of adverse reaction Provide electronic options for 253 30
particularly with the current voluntary reporting schemes. submitting reports
Make reporting mandatory 30 3
About seven million patients were exposed to fenfluramine Provide toll free number 52 6
before the association with valvular heart disease led to Make public more aware of reporting 8 1
its withdrawal from market.[6] This prompted us to check Make medical practitioner more 17 2
if the under‑reporting was due to any other reasons aware of reporting
Ensure confidentiality of reports 13 1
besides the voluntary reporting scheme. In the literature, Different combinations of above 147 17
we found many surveys on knowledge, attitude, and suggestions
perceptions/practices of medical practitioners. However, Total 870 100
such surveys were conducted using relatively small number
of subjects and/or were limited to a specific region/area we also tried to cull out the information on number of
or using specific population of respondents. We thought voluntarily reported ADRs to authorities, and/or other
of conducting this survey on all‑India basis by selecting a related organizations like (nongovernment organizations)
representative sample of relatively large number of medical and manufacturing companies.
practitioners selected from four different zones – North,
East, West, and South. The purpose of the questionnaire, Our findings, like previously published results of earlier
like other surveys, was basically to identify the factors, if surveys, suggest that there is a reasonable amount of
any, responsible for underestimation of ADRs. In addition knowledge or awareness in the medical practitioners about

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 Kharkar and Bowalekar: KAP of Indian medical practitioners towards ADR reporting

importance of ADRs and also majority perceive that CONCLUSION

Government or private ADR centers are very useful, yet in
practice there is lot of lethargy toward reporting of ADRs. Analysis of data generated in our survey revealed that the
To be specific, our findings are in agreement with Madhan knowledge about ADR reporting exists among medical
Ramesh[7] who had similar observations and suggestion in a practitioners in addition to the right perception toward
survey of about 100 medical Practitioners. Rehan HS[8] in a ADR reporting. However the practice of ADR reporting is
survey of 107 fifth semester MB,BS undergraduate students discouraging. For some reasons the act of reporting ADRs
and 117 prescribers found that the knowledge, attitude, to appropriate authorities is not up to the mark leading to
and practices of both undergraduates and prescribers under reporting of ADRs in this country.
comparable yet need further improvement. They concluded
that there is a need for suitable changes in the undergraduate
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the extend of under‑reporting of ADRs. Source of Support: Nil. Conflict of Interest: None declared.

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