Original Article Sandeep Kumar Gupta, Roopa P. Nayak1, R. Shivaranjani2, Surendra Kumar Vidyarthi3 1,3 Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India

2

Address for correspondence: Dr. Sandeep Kumar Gupta, Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur ‑ 621 212, Tamil Nadu, India. E‑mail:  [email protected]

Ab stract

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. Key words: Adverse drug reactions, attitude, knowledge, pharmacovigilance, practice, spontaneous reporting, under‑reporting

Access this article online Quick Response Code:

Website: www.picronline.org DOI: 10.4103/2229-3485.148816

45

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 Perspectives in Clinical Research | January-March 2015 | Vol 6 | Issue 1

Gupta, et al.: A questionnaire study on the knowledge, attitude, and practices of pharmacovigilance

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 Phar macovigilance 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.[3,4] 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,[1‑16] it is imperative to conduct similar studies in teaching hospital of other parts of India to generalize findings of those studies.[3,5] 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 Perspectives in Clinical Research | January-March 2015 | Vol 6 | Issue 1

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.[1‑3,5,8,9,11,16] 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. 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 Table 1: Demographic details of the healthcare professionals (n=101) Frequency (%) Gender Female Male Mean age (in years) Age distribution (in years) 19-25 26-30 31-35 36-40 >40 Professional status Doctors Nurses Pharmacist

54 (53.5) 47 (46.5) 31.52±10.63 34 (33.7) 29 (28.7) 16 (15.8) 10 (9.9) 12 (11.9) 50 (49.5) 44 (43.6) 7 (6.9)

46

Gupta, et al.: A questionnaire study on the knowledge, attitude, and practices of pharmacovigilance

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]. 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]. Practice

Among the participants, 64.4% have experienced ADRs in patients and 58.4% have seen the ADR reporting form. Table 2: Knowledge related questions and percentage of correct and incorrect responses Knowledge‑related questions

Define pharmacovigilance The most important purpose of pharmacovigilance is Do you think ADR reporting is professional obligation for you? The healthcare professionals responsible for reporting ADRs in a hospital are Do you know regarding the existence of Pharmacovigilance Programme in India? In India which regulatory body is responsible for monitoring ADRs? Where the international center for adverse drug reaction monitoring is located?

Correct response (%)

Incorrect response (%)

62.4 66.3

37.6 33.7

69.3

30.7

80.2

19.8

75.2

24.8

78.2

21.8

41.6

58.4

ADR=Adverse drug reaction

Table 3: Attitude‑related questions and percentage of correct and incorrect responses Attitude related questions

Do you think reporting of adverse drug reaction is necessary? Do you think Pharmacovigilance should be taught in detail to healthcare professionals? Have you anytime read any article on prevention of adverse drug reactions? What is your opinion about establishing ADR monitoring center in every hospital? ADR=Adverse drug reaction

47

Correct response (%)

Incorrect response (%)

97

3

92.1

7.9

65.3

34.7

74.3

25.7

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]. 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 

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

The primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilan...
712KB Sizes 0 Downloads 7 Views

Recommend Documents


A study on knowledge, attitude and practice of contraception among college students in Sikkim, India.
Kolej öğrencilerinin kontrasepsiyon haklkındaki bilgi, tecrübe ve tavırlarını değerlendirmek.

Pharmacovigilance practices for better healthcare delivery: knowledge and attitude study in the national malaria control programme of India.
Objective. With large scale rollout of artemisinin based therapy in the National Malaria Control Programme of India, a risk management plan is needed. This depends on adverse drug reaction (ADR) reporting by the healthcare professionals (HCPs). For t

Knowledge, perception and practice of pharmacovigilance among community pharmacists in South India.
Pharmacovigilance has not progressed well in India and the concept is still in its infancy. India rates below 1% in pharmacovigilance as against the world rate of 5%.

Impact of training on Nigerian healthcare professionals' knowledge and practice of pharmacovigilance.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem.. The effectiveness of this system revolves on the active participation

Knowledge, attitude and practice of antibiotics: a questionnaire study among 2500 Chinese students.
Recently, many scientists including bacteriologists have begun to focus on social aspects of antibiotic management especially the knowledge, attitude and practice (KAP) among the general population regarding antibiotic use. However, relatively few wo

Biomedical waste management: study on the awareness and practice among healthcare workers in a tertiary teaching hospital.
Bio-medical waste has a higher potential of infection and injury to the healthcare worker, patient and the surrounding community. Awareness programmes on their proper handling and management to healthcare workers can prevent the spread of infectious

Pharmacovigilance Knowledge among Patients at a Teaching Hospital in Lalitpur District, Nepal.
Consumer's knowledge and perception towards adverse drug reactions (ADR) can play an important role in ensuring a healthy lifestyle and proper use of medicines.

AIDS Knowledge, Attitude and Risk Perception among Pregnant Women in a Teaching Hospital, Southwestern Nigeria.
The rising HIV infection rates among women especially of child bearing age particularly in Sub-Saharan Africa expose children to increased HIV risk even before they are born. Without effective measures or awareness campaigns to deal with mother-to-ch