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

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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