Post on 01-Jun-2020
Original Article
1 2Pauline Packiaseeli. S, Ashok Kumar. T
ABSTRACT
Introduction: Under-reporting of ADRs is very common. Healthcare professionals need to be
motivated regarding ADR reporting. Hence this study is aimed at evaluating the awareness and
practice of medical faculties regarding pharmacovigilance.
Objectives: Primary objective: To evaluate the awareness of pharmacovigilance among medical
faculties.Secondary objective: To assess the attitude and practice of ADR reporting among medical
faculties.
Materials and Methods: The clinicians were asked to fill up a prepared Questionnaire. The results
were analyzed by calculation of percentages.
Results : Only 36% of the respondents knew that doctors, nurses, pharmacists and physiotherapists
can report ADRs. 64% of the clinicians answered correctly that events related to all such as herbals,
traditional medicines, blood products, medical devices and vaccines to be registered.42% of them
knew that ADR due to new drugs, new ADR to drugs already in use, common known adverse events
of old drugs, any suspected ADR, the cause may be unknown, any drug interactions, death due to
drug interactions and congenital anomalies, all should be reported. 36% of them said no only to
common known adverse events of old drugs. 13% of the individuals said no to congenital
anomalies.42% of them knew that there is an ADR reporting center in their Institution and 12% of
them have reported ADRs to that center.
Conclusion: Under reporting of ADRs is mainly due to lack of adequate knowledge and practice in
filling up the ADR reporting form. This will be rectified shortly, by organizing CME programs,
workshops and seminars in our Institution.
Keywords: ADR reporting, knowledge, awareness, practice, clinicians, Tertiary care hospital.
INTRODUCTION:
harmacovigilance is defined as a
multidisciplinary field which studies the Pscience and activities relating to the
detection, assessment, understanding and
prevent ion of adverse drug react ions .
Pharmacovigilance reporting centers were created
to encourage the health institutions to report ADRs.
Under-reporting of ADRs is very common.
Address for correspondence:
S.Pauline Packiaseeli, Assistant Professor, Department of Pharmacology, Kanyakumari Government Medical College,
Nagercoil, Kanyakumari District, Tamilnadu. Mobile no: 8012212635. Email id: paulinepackiaseeli.s@gmail.com
1Assistant Professor, Department of Pharmacology, Kanyakumari Government Medical College, India.2Professor, Department of Pharmacology, Kanyakumari Government Medical College, India.
National Journal of Basic Medical Sciences | Volume 7 | Issue 4 | 2017
Evaluation of Awareness and Attitude Towards Pharmacovigilance
Among Clinicians in A Tertiary Care Hospital
Healthcare professionals need to be motivated
regarding ADR reporting. Hence this study is
aimed at evaluating the awareness and practice of
clinicians regarding pharmacovigilance. Most of
the previous similar studies have been done with
only general practitioners, whereas this study is
exclusively done among clinicians in a tertiary care
hospital.
235
236National Journal of Basic Medical Sciences | Volume 7 | Issue 4 | 2017
OBJECTIVES:
Primary objective: To evaluate the awareness of pharmacovigilance
among medical faculties.
Secondary objective: To assess the attitude and practice of ADR reporting
among medical faculties.
Trial design: A cross sectional study
Duration: 3 months
MATERIALS AND METHODS:
A Questionnaire was developed comprising of 12
questions which includes questions regarding
knowledge, attitude towards adverse reactions
reporting, practice of ADR reporting and future of
ADR reporting. The questions in the questionnaire
were adopted from the questionnaires used in
previous similar studies. The study was conducted
after approval from the Institutional Ethical
Committee. The questionnaire was distributed to
the clinicians who gave consent to fill up the
questionnaire. The questionnaire was distributed
directly to the clinicians by the principal
investigator and co-investigator and the filled up
questionnaires were received on the same day from
the doctors. Only 93 doctors returned the filled up
questionnaires to the investigators. Our aim was to
do the study with only the clinicians in our hospital.
So, sample size was not calculated. The results
were analyzed by calculation of percentages.
RESULTS:
Regarding the knowledge about who can report
ADRs, the percentage of clinicians who had given
the following answers is given in the table 1.
Table1. Professionals qualified to report an ADR
*percentage of respondents who answered yes to
these answers
Only 36% of the respondents knew that doctors,
nurses, pharmacists and Physiotherapists can
report ADRs.
The percentage of clinicians who favoredthat the
ADR related to theparticularevents also should be
reported is shown in the table 2.
Table 2. Events related to these to be reported or
not?
*percentage of respondents who answered yes to
these answers
64% of the clinicians answered correctly that
events related to all such as Herbals, Traditional
medicines, Blood products, medical devices and
vaccines to be registered.
42% of them knew that ADR due to new drugs, new A D R t o d r u g s a l r e a d y i n u s e , Common known adverse events of old drugs, any suspected ADR, the cause may be unknown, any drug interactions, death due to drug interactions
S.Pauline Packiaseeli, et.al : Awareness and attitude towards pharmacovigilance among clinicians
237National Journal of Basic Medical Sciences | Volume 7 | Issue 4 | 2017
and congenital anomalies, all should be reported. 36 % of them said no only to common known adverse events of old drugs. 13 % of the individuals said no to congenital anomalies.
No one has written the correct place of location of central ADR reporting center & monitoring center and also no one has reported ADRs to any of these centers.
42% of them knew that there is an ADR reporting center in their Institution and 12% of them have reported ADRs to that center.
The attitude of the doctors regarding ADR reporting is given in the table 3.
Table 3. Attitude towards ADR reporting
*percentage of respondents who answered yes to the above questions
Table-4. How should the ADR reporting be made?
Table 4 shows the opinion of the clinicians regarding ADR reporting.
*percentage of respondents who chose the above answers
Table 5. Inclination of the clinicians to report an ADR
Table 5 shows the inclination of the clinicians to
report various types of ADRs.
*percentage of respondents who answered yes to
the above answers
38% answered yes to all the above
28% answered yes to all except 'well recognized
adverse events of a drug'.
19% answered yes only to ADR to a new drug.
Table 6. Discouraging factors for reporting an
ADR
*percentage of respondents who chose the above
answers
Discouraging factors suggested by the clinicians is
shown in the above table 6.
DISCUSSION:
Regarding the knowledge based questions, 36% of
the respondents knew that all (doctors, nurses,
pharmacists, physiotherapists can report ADRs). In
a post test questionnaire study by Santhosh Kumar 1et al it was 88%.
64% of them answered correctly those ADRs
regarding all (Herbals, Traditional medicines,
Blood products, medical devices and vaccines) to
be registered. It was 80% in a study by Maharani et 2al.
42% of them knew that they should report all types
of ADR .This result was better than in the study by 2
Maharani et al where it was only 15%.
S.Pauline Packiaseeli, et.al : Awareness and attitude towards pharmacovigilance among clinicians
238National Journal of Basic Medical Sciences | Volume 7 | Issue 4 | 2017
No one knew the central ADR reporting center and
also no one had reported an ADR to any of the
centers whereas in a Mumbai based study by Gupta 3
P et al 29% of them have reported an ADR. So, it
shows that our clinicians have only average
knowledge about Pharmacovigilance and it should
be rectified by conducting CME programs.
42% of them knew that there was an ADR reporting
center in their Institution and 12% have reported
ADRs there. In the study by Desai et al4 only 25%
of them knew that they could report to the
peripheral ADR monitoring center in their
Institution and 24% of them have reported ADRs.
This shows that there is awareness about the
peripheral center but the reporting of ADRs should
be encouraged.
96% of them have said that ADR reporting is
necessary. This result is similar to other studies by 5 3
Datta et al (97%) and Gupta et al (90%). 94% of
them have said that ADR reporting is an
professional obligation which is in sharp contrast
showing 36% in a study in Nagpur by Pimpalkhute 6SA et al . This shows the positive attitude of our
clinicians to the pharmacovigilance program.
81% of them have stated that ADR reporting should
be made compulsory. So, we can see that there is a
definite commitment and willingness on the part of
clinicians to report ADRs.
Only 9% of the individuals said that ADR reporting
should be remunerated, whereas it 17% in the study 6
by Pimpalkhute et al . Remuneration is not a viable
solution as this increases the possibility of dubious 7
reporting Fadare et al .
Regarding Inclination to report an ADR 38% would
like to report all events, while 25% would report all
except well recognized adverse events of a drug
and 19% only ADRs to new drugs. This result was 4
more or less similar to a study by Desai et al where
51% of them liked to report all ADRs and 34%
would like to report ADR due to new drugs.
The most common discouraging factor was that
they do not know how to report, when and where to
report (73%).The next common discouraging
factor was that they had a concern that the report
may be wrong (47%). This percentage was high 5
compared to another study by Datta etal where
only in 3.5% of them noted that 'uncertainty
whether an ADR had occurred' to be a discouraging
factor. This could be rectified by conducting a
workshop about ADR reporting.
Lack of time for ADR reporting was said by 36% of
them, which was similar (33%) in the study by 5Datta et al and also similar in other studies by Khan
9et al8 and Reddy et al . Now, ADR reporting has
been made very easy with a simple' ADR reporting
form' which the physician has to fill up. This could
be done easily by proper teaching of the faculties
through workshops.
CONCLUSION:
The doctors in our Institutions have a positive
attitude towards ADR reporting and willingness to
contribute to our country's ADR database but only
lack of adequate knowledge prevents them in
participating in the National Pharmacovigilance
Program. This will be rectified shortly, by
organizing CME programs, workshops and
seminars in our Institution.
S.Pauline Packiaseeli, et.al : Awareness and attitude towards pharmacovigilance among clinicians
239National Journal of Basic Medical Sciences | Volume 7 | Issue 4 | 2017
REFERENCES:
1. Santhosh Kumar Madhusudhan, Shashikala
GH Evaluation of knowledge, awareness,
and Practice of Pharmacovigilance among
Practicing doctors, Asian Journal of
Pharmaceutical and Clinical Research. 2016;
9(3): 283.
2. Maharani B, Paramesh Kaliah Attitudes and
knowledge of medical Practitioners at Salem
towards Pharmacovgilance Reporting
system, National Journal of Basic medical
Sciences, 2013 ;III (4) :294-299.
3. Gupta P, Udupa A. Adverse drug reaction
repor t ing and pharmacovig i lance ;
Knowledge, attitudes and perceptions among
resident doctors. J Pharm Sci.2011; 3:1064-
9.
4. Chetna K.Desai. Geetha Iyer, Jigar Panchal,
Samidh Shah, and R.K.Dikshit, An
Evaluation of Knowledge, attitude, and
practice of adverse drug reaction reporting
among prescribers at atertiary care hospital,
Perspectives in clinical research2011 Oct-
Dec;2(4):129- 136.
5. Supratim Datta and Shramana Sengupta , An
Evaluation of Knowledge, attitude, and
practice of adverse drug reaction reporting
among prescribers at a tertiary care hospital
in Sikkim, Perspectives in clinical research
2015 Oct-Dec;6(4);200- 206.
6. Pimpalkhute SA, Jaiswal KM, Sontakke SD,
Bajait CS, Gaikwad A. Evaluation of
awareness about pharmacovigilance and
adverse drug reaction monitoring in resident
doctors of a tertiary care hospital. Indian J
Med Sci .2012; 66:55-61.(Pub Med).
7. Fadare JO, Enwere OO, Afotabi AO, Chedi
BA, Musa A Knowledge, attitude and
practice of adverse drug reaction reporting
among healthcare workers in a tertiary care
centre in northern Nigeria. Trop J Pharm Res.
2011; 10:235-42.
8. Khan SA, Goyal C, Chandel N, Rafi M.
Knowledge, attitudes and practice of doctors
to adverse drug reaction reporting in a
teaching hospital in India: An Observational
study. J Nat Sci Biol Med .2013; 4:191-
6.(Pub Med)
9. Reddy P, Varma SK, Reddy S. Knowledge,
attitude and practice of ADR reporting
among clinical residents: A rural medical
college survey. J Drug Discover Ther. 2014;
2:8-13.
Received on 19/05/2017 Revised on 26/06/2017 Accepted on 27/06/2017
S.Pauline Packiaseeli, et.al : Awareness and attitude towards pharmacovigilance among clinicians