A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India.

OBJECTIVE: The primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Perambalur (Tamil Nadu), a tertiary care teaching hospital. The second primary objective was to assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India. The secondary objective was to compare the findings of this study with the results of the published studies from India on evaluation of the KAP of pharmacovigilance among healthcare professional.
MATERIALS AND METHODS: A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the DSMCH, Perambalur (Tamil Nadu) during the study period were included. Only those who gave their consent to participate were included in the study. The data was analyzed by using the Statistical Package for Social Sciences (SPSS) statistical software, version 16.
RESULTS: One hundred and fifty pretested questionnaires were distributed among the healthcare professionals and 101 responded. 62.4% healthcare workers gave correct response regarding the definition of pharmacovigilance. 75.2% of healthcare workers were aware regarding the existence of a National Pharmacovigilance Program of India. 69.3% healthcare professional agreed that ADR reporting is a professional obligation for them. Among the participants, 64.4% have experienced ADRs in patients, but only 22.8% have ever reported ADR to pharmacovigilance center. Unfortunately only 53.5% healthcare workers have been trained for reporting adverse reactions. But, 97% healthcare professionals agreed that reporting of ADR is necessary and 92.1% were of the view that pharmacovigilance should be taught in detail to healthcare professional.
CONCLUSION: This study demonstrated that knowledge and attitude towards pharmacovigilance is gradually improving among healthcare professionals, but unfortunately the actual practice of ADR reporting is still deficient among them.

INTRODUCTION

One of the major reasons of morbidity and mortality all over the world is adverse drug reactions (ADRs). Hence, proper monitoring of ADRs is a necessity. In India, all healthcare professionals including doctors, nurses, and pharmacists can report an ADR by filling an ADR form of the Central Drugs Standard Control Organization.[1] It is important for healthcare professionals to know how to report and where to report an ADR. The active participation of healthcare professionals in the pharmacovigilance program can improve the ADR reporting.[2]

Notwithstanding the constant endeavor by the Pharmacovigilance Programme of India towards inculcating a culture of ADR monitoring; underreporting is still very prevalent. There is a requirement for constant training and enactment of regulations for ADR reporting among healthcare professionals. Previous reported study has found that underreporting of ADR is related with shortcomings in the knowledge and attitude among healthcare professionals.[34]

Therefore the primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Perambalur (Tamil Nadu), a tertiary care teaching hospital. Although many studies in India have evaluated the KAP of pharmacovigilance among the healthcare professionals,[12345678910111213141516] it is imperative to conduct similar studies in teaching hospital of other parts of India to generalize findings of those studies.[35] The second primary objective was to assess the causation of underreporting of ADRs as it needs to be well-assessed in India. The secondary objective was to compare the findings of this study with the results of the published studies from India on evaluation of the KAP of pharmacovigilance among healthcare professional.

MATERIALS AND METHODS

Setting

This study was conducted at DSMCH, a tertiary care Hospital in Perambalur, Tamil Nadu, India. The approval for conducting this study was obtained from the human institutional ethics committee of this college. The duration of the study was 2 months, from June 2013 to July 2013.

Study design

The study was a cross-sectional questionnaire-based study. The study participants consisted of all the healthcare professionals (doctors, nurses, and pharmacists) who gave their informed consent and who were working at the hospital during the study period.

KAP questionnaire was designed to assess the demographic details of the healthcare professionals, their knowledge of pharmacovigilance, attitudes towards pharmacovigilance, and their practice on ADR reporting. There were 20 questions in all (seven related to knowledge, four related to attitude, and eight related to practice). One question was asked to determine the reasons for underreporting. These questions were designed based on earlier studies for assessing KAP of ADR reporting.[1235891116]

Pretesting of questionnaire was done on 20 randomly selected health professionals of the institute. The questionnaire was finalized after ambiguous and unsuitable questions were modified based on the result of pretest.

Data collection

One hundred and fifty pretested questionnaires [see Appendix-1] were distributed among the healthcare professionals. A time of 1 day was given for collection of the anonymously filled forms.

Statistical analysis

Information from the returned pretested questionnaire was coded and entered into Statistical Package for Social Sciences (SPSS) version 16 software. Spearman's correlation was used to determine any relationship between training of pharmacovigilance and reporting ADR.

RESULTS

Demographic details

The demographic details of the healthcare professionals are summarized in Table 1.

Table 1

Demographic details of the healthcare professionals (n=101)

Response rate

One hundred and fifty questionnaires were distributed among the healthcare professionals and 101 responded (response rate 67.33%).

Knowledge

62.4% healthcare workers gave correct response regarding the definition of pharmacovigilance. 66.3% healthcare professional were aware that the most important purpose of pharmacovigilance is to identify safety of the drug. 69.3% healthcare professional agreed that ADR reporting is a professional obligation for them. 75.2% of healthcare workers were aware regarding the existence of a Pharmacovigilance Programme of India. 78.2% were aware that the regulatory body responsible for monitoring ADRs in India is Central Drugs Standard Control Organization (CDSCO). 41.6% were aware that International Center for ADR monitoring is located in Sweden [Table 2].

Table 2

Knowledge related questions and percentage of correct and incorrect responses

Attitude

A total of 97% healthcare professionals agreed that reporting of ADR is necessary. 92.1% were of the view that pharmacovigilance should be taught in detail to healthcare professional. 65.3% participants have read articles on prevention of ADRs. 74.3% healthcare professional agreed that ADR monitoring center should be established in every hospital [Table 3].

Table 3

Attitude-related questions and percentage of correct and incorrect responses

Practice

Among the participants, 64.4% have experienced ADRs in patients and 58.4% have seen the ADR reporting form. 71.3% participants know regarding pharmacovigilance committee in their institute. But only 22.8% have ever reported ADR to pharmacovigilance center. Only 53.5% participants had ever been trained on reporting ADRs. Unfortunately, only 13.9% healthcare professional were aware that a serious adverse event should be reported to the regulatory authority within 14 calendar days. Merely 44.6% were aware that rare ADRs can be identified during phase 4 clinical trial and 32.7% were aware regarding spontaneous reporting system as a tool to monitor ADRs of new drugs [Table 4].

Table 4

Practice-related questions and percentage of response

Reasons for under-reporting

The factors discouraging participants from reporting ADRs were no remuneration (31.7%), lack of time to report ADR (23.8%), belief that a single unreported case may not affect ADR database (21.8%), and difficulty to decide whether ADR has occurred or not (22.8%).

Correlation between training of pharmacovigilance and reporting ADR

The correlation between the training of pharmacovigilance and reporting ADR was analyzed by using Pearson's correlation coefficient. The analysis shows that there was a medium, positive correlation between training of pharmacovigilance and reporting ADR by healthcare professional (r = 0.327, n = 101, P < 0.001) [Table 5].

Table 5

Correlation between training of pharmacovigilance and reporting adverse drug reaction

DISCUSSION

The fact that majority of respondents agreed that reporting of ADR is necessary and pharmacovigilance should be taught in detail to healthcare professionals is a major findings from our study. In this study there was huge gap between the ADR experienced (64.4%) and ADR reported (22.8%) by healthcare professional. The factors responsible for underreporting were also determined in this study. The determinants of underreporting, from our study include no remuneration, lack of time to report ADR, belief that a single unreported case may not affect ADR database, and difficulty to decide whether ADR has occurred or not. Other reasons were lack of training, unawareness regarding the ADR reporting form, ignorance of the rules, and procedure for reporting.

The comparison with the results of the published studies from India [Tables 6–8] demonstrated that knowledge and attitude towards pharmacovigilance is gradually improving among healthcare professionals, but unfortunately the actual practice of ADR reporting is still deficient among them. The adverse event reporting rate from our study is low which is similar to previously reported different Indian studies from Trivandrum,[2] Nagpur,[16] Bangalore,[4] Jalandhar,[5] Ahmedabad,[9] and Indore.[3] Most importantly, the huge gap between the ADR experienced and ADR reported by healthcare professional was also evident in previously reported studies conducted in Trivandrum,[2] Nagpur,[16] Bangalore,[4] and Ahmedabad.[9] In our study, less percentage of participants had ever been trained on reporting ADRs which is similar to the low percentage of training imparted to healthcare professionals in previously reported studies from Indore[3] and Trivandrum.[2]

Table 6

Comparison with results of the published studies from India (knowledge-related questions)

Table 8

Comparison with results of the published studies from India (practice-related questions)

Our study reemphasized the fact that there is positive correlation between training of pharmacovigilance and reporting ADR by healthcare professional and it demonstrated that the significance of adverse event monitoring and reporting can be increased through academic interference. Factors such as the unawareness about the method to decide the causal relationship between the ADR can only be removed by regular training.[2] The suggestions to improve the ADR reporting rate have been enumerated in Table 9.

Table 9

Suggestions to improve the ADR reporting rate

Strengths and Limitations of the Study

To the best of our knowledge, very few studies have been done to assess the KAP of pharmacovigilance among healthcare professional in the state of Tamil Nadu (India). One such recently published study is by Arbind et al.,[13] Our study included not only doctors but nurses and pharmacist also because among the healthcare providers, nurses, and pharmacist are in a unique position to monitor and report ADRs.

The major limitation of this study was the essentially small number of participants. In addition, some other factors that are associated with self-reporting studies such as accuracy of recall, personal bias could also have affected the results of this study in some ways.

CONCLUSIONS

In conclusion, this study showed that majority of the healthcare professionals had good knowledge and attitude about pharmacovigilance and understand the need for reporting. In spite of that the reporting rate of ADRs by them is very low. Hence, there was huge gap between the ADR experienced and ADR reported by healthcare professional. It was also found that there is a positive correlation between training of pharmacovigilance and reporting ADR by healthcare professional. The fact that majority of respondents agreed that reporting of ADR is necessary and awareness that pharmacovigilance should be taught in detail to healthcare professionals emphasize that they have started to understand the importance of pharmacovigilance.

Table 7

Comparison with results of the published studies from India (attitude-related questions)