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 Table of Contents  
Year : 2018  |  Volume : 6  |  Issue : 1  |  Page : 32-35

Impact of educational intervention on knowledge, attitude, and practice of pharmacovigilance among nurses

Department of Pharmacology, MMIMSR, Ambala, Haryana, India

Date of Web Publication11-Jun-2018

Correspondence Address:
Dr. Divya Goel
Department of Pharmacology, MMIMSR, Ambala, Haryana
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/amhs.amhs_6_18

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Introduction: Pharmacovigilance (PV) helps in gathering adverse drug reaction (ADR) data regarding drugs. However, underreporting of ADR is still very high among health-care professional due to lack of knowledge and awareness. Nurses can play a vital role in collection of ADR data. However, at present, we have little data about awareness of PV among nurses in India. This study was planned to know the level of knowledge, awareness, and practice of PV among nurses and subsequent change in these after educational intervention PV session. Materials and Methods: We conducted a cross-sectional descriptive questionnaire-based study among nursing staff of a Tertiary Health Care and Teaching Institute. Nursing staff was given pre-designed descriptive questionnaire. Participants were asked to fill knowledge, attitude, and practice (KAP) questionnaire before and after interactive educational training program. The impact of the educational intervention was evaluated by comparing the pre- and post-intervention questionnaire using Fisher's exact test. Results: A total of 98 participants filled the questionnaires before and after the educational intervention. Educational program on PV was found to statistically increase the correct response regarding knowledge and positive attitudes toward various aspects of PV. Conclusion: The KAP of nurses increased after training program on PV. It increased their level of awareness about principles and techniques of PV. Such educational intervention if held regularly can help in long-term practice of PV.

Keywords: Adverse drug reaction, attitude, educational intervention, knowledge, nurses, pharmacovigilance, practice

How to cite this article:
Goel D. Impact of educational intervention on knowledge, attitude, and practice of pharmacovigilance among nurses. Arch Med Health Sci 2018;6:32-5

How to cite this URL:
Goel D. Impact of educational intervention on knowledge, attitude, and practice of pharmacovigilance among nurses. Arch Med Health Sci [serial online] 2018 [cited 2023 Mar 31];6:32-5. Available from: https://www.amhsjournal.org/text.asp?2018/6/1/32/234110

  Introduction Top

Adverse drug reactions (ADR) are one of the major causes of morbidity and mortality in patients.[1] ADR is defined as “a response to a medicament which is noxious and unforeseen and which happens at dosages ordinarily utilized for the diagnosis, prophylaxis or treatment of a disease or the alteration of physiological function.”[2] ADRs also put a considerable economic burden on the health-care system and society, thus posing a major impact on public health.[3] The World Health Organization defined the term pharmacovigilance (PV) as “The pharmacological science and activities relating to the detection, assessment, understanding, and prevention of the adverse effects, or any other drug-related problems.”[4] Now, it has broadened the scope of PV to incorporate herbal, traditional and complementary medicines, blood products, medical devices, and vaccines.[5] Studies done worldwide showed that ADRs produce a significant reduction in the quality of life, increase hospitalization, lengthen hospital stay, and increase mortality.[6] The cost of drug-related morbidity and mortality exceeded 177.4 million dollars as on 2000, of which about 70% were expenses for drug-related hospital admissions.[7] To curb it ADR reporting plays a pivotal role. The international database of ADRs is maintained by the Uppsala Monitoring Center, Sweden.[8] In India, new PV program was started in July 2010 with the aim to safeguard people's health.[9] Under it, many ADRs monitoring center (AMC) are opened in medical colleges to encourage spontaneous ADRs reporting by both the health-care professionals and patients to strength the PV program of India.[9] However, still under-reporting of ADRs is there.[10] By knowing the reason for ADR under-reporting, we can help in improving ADRs reporting. One of the main reasons for under-reporting is found to be lack of knowledge, attitude, and practice (KAP) of PV among health-care professionals.[11] This issue can be tackled by creating more awareness about PV through educational interactive programs. This study was planned to know the impact of educational program on KAP of PV among nurses.

Aims and objectives

The aim behind conducting this study was to know the KAP of the nurses toward PV and impact of the training session on PV.

  Materials And Methods Top

Study design and study site

A cross-sectional descriptive KAP questionnaire-based study was done on nurses of Maharishi Markandeshwar Institute of Medical science and Research, Mullana, Ambala, during 2016.

Study instrument

After obtaining verbal consent from the participants, the study was commenced. The participants were ensured that their participation is voluntary, and confidentiality will be maintained. Initially, all the participants were briefed about the purpose of the study; later, a self-administrated pre-validated questionnaire adapted from previous studies was framed in English language; it consists of three parts. The first part (Question No. 1–9) contained the set of questions seeking the knowledge of nurses about PV. Part two (Question No. 10–13) contained questions to know their attitude toward PV. The third part (Question No. 14–18) contained set of questions to assess their practical aspects of PV. The questionnaire (Pre-KAP) was administered, and participants were asked to submit the completed questionnaire. Every participant was given 30 min to fill up the questionnaire. An interactive educational intervention was designed in the form of power point presentation by trained faculty to all nurses to facilitate the transfer of knowledge of PV and ADR's reporting. The educational intervention consisted of hands-on training and theoretical presentation on what is PV, its main objectives, ADRs reporting, VigiFlow database, classification of ADRs, incidence of ADRs, role of health-care professionals, reporting of suspected ADR followed by economic and epidemiological importance of reporting the ADRs and its effect on patient health care. After the interactive educational intervention program on PV, all participants in the study were again administered with (Post-KAP) questionnaire.

Statistical analysis

Statistical analysis was done using descriptive statistics. To measure changes in the knowledge and attitude toward PV among nurses between pre- and post-intervention and to evaluate the impact of effectiveness of educational intervention among nurses the Fisher's exact test was used to compare the difference in correctness for each question. To see the practice of PV in nurses, correctness was analyzed in percentage. All statistical calculations were performed using Graphic Pad, a web-based epidemiological and statistical calculator. The significance was assessed at a 5% level of significance (P< 0.05) with 95% confidence interval.

  Results Top

The KAP study on PV before and after education intervention was done on the nurses of the institution. In this cross-sectional study, a total of 98 nurses participated and filled the questionnaires before and after the educational intervention.

Assessment of knowledge toward pharmacovigilance pre- and post-educational intervention

The answers seeking the knowledge of PV of the participants are depicted in [Table 1]. Knowledge about the PV among the participants was assessed by Part-I (Question No. 1–9) of the questionnaire [Table 1]. Thirty participants (30.6%) were aware of the term PV. Among the participants who were aware of the term PV, most of them 29 (99%) had knowledge about the function of PV and 25 (25.5%) participants had knowledge about the regulatory body of PVPI. With respect to the awareness about AMC of the institution for PV, only 28 (28.6%) knew its location in the institution, out of this, only 15 (53.8%) knew the intercom telephone number of the AMC center. Only 13 (13.3%) furnished precise response about ADR reporting. With reference to the question “who can report ADR?” 22 (22.4%) participants gave correct response. Only 2 (2.04%) participants gave correct response with respect to the time period within which a serious ADR should be reported, while 12 (12.24%) gave correct response as to which kind of ADRs should be reported. There was statistically significant (P = 0.0001) increase in the KNOWLEDGE regarding PV Post-KAP as compared to Pre-KAP.
Table 1: Knowledge of pharmacovigilance and adverse drug reactions reporting before and after educational intervention

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Assessment of attitude toward pharmacovigilance pre- and post-educational intervention

It was assessed by Part-II (Question No 10–13) of the Questionnaire [Table 2]. For the question on the necessity of ADR reporting, 29 (29.6%) participants agreed that ADR reporting should be necessary. Twenty-five (25.5%) participants wanted ADR reporting should be made mandatory. When asked whether PV can help in better health care 14 (14.3%) agreed but posteducational intervention, 78 (79.6%) agreed to it. About 64 (65.3%) of participants had positive perception that PV should be taught in detail to all health-care professionals during their curriculum. As shown in [Table 2], there was a statistically significant (P = 0.0001) increase in the correct response by the participants after the educational intervention (Post-KAP).
Table 2: Attitude of pharmacovigilance and adverse drug reactions reporting before and after educational intervention

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Assessment of pharmacovigilance practice pre- and post-educational intervention

The PV practice of ADRs reporting was assessed by the Part-III (Question No. 14–18) of the questionnaire [Table 3]. This study showed that although 35 (35.7%) participants had come across an ADR, but only 19 (54.3%) participants had ever reported an ADR. The main reasons of not reporting an ADR by the participants was not knowing how to report. Ninety-four (95.9%) participants had never undergone any kind of training on reporting ADRs or PV.
Table 3: Practice of pharmacovigilance and adverse drug reactions reporting before educational intervention

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  Discussion Top

Spontaneous ADR reporting plays a vital role in PV program. One of the major hindrances is found to be lack of knowledge about PV among health-care professionals. This study was conducted on nurses with aim to assess their KAP about PV and change in it after PV program. Nurses play an important role in patient healthcare and drug administration. This study showed that nurses lack the knowledge regarding PV and ADR reporting system; it might be due to little exposure to the practical Pharmacology and PV-related activities. The nursing students get exposed to pharmacology in the 2nd year of their curriculum and by the time these students complete their course, the knowledge and awareness regarding PV is washed out. The practical knowledge of the nursing students needs to be upgraded to prepare them for future challenges.

In our study, more than half of the study participants were unaware of the correct meaning and function of PV, regulatory authority of PVPI. The participants had poor knowledge regarding institution AMC center and its telephone number. They also have poor knowledge regarding timeframe for reporting of serious adverse events, who can report the ADRs and what type of ADRs to report. The knowledge of PV assessed through this study in nurses was similar to the various previous studies done on health-care professionals.[12],[13] For the question on whether PV can help in better health-care pre-intervention 14 (14.3%) participants agreed, But posteducation intervention 78 (79.6%) participants agreed to it. This is similar to another studies in which response among doctors and nurses for this was 28.3%. [14,15] Hema et al. also showed that lack of knowledge and awareness about PV among the health-care professional as the main reason for under-reporting of ADRs.[15] A study by Praveen et al.[16] concluded the lack of knowledge and awareness was found to be the most common cause of failure in successful implementation of the PV program of India.

In our study, 29 (29.6%) participants agreed that reporting ADRs is necessary and 25.5% participants agreed that ADR reporting should be made mandatory. In another study found that ADR reporting was considered to be important by 97.3% of the respondents.[17] In our study, the overall attitude toward ADR reporting and PV was acceptable, however, the actual practice of ADR reporting was lacking.

Postintervention nearly 90% of participants wanted to have more extensive training in PV as part of their on-going professional development, which is similar to result shown by other study.[18] In our study, the focus of educational intervention was to increase the awareness of nurses to PV, information pertaining to AMC. This was demonstrated by an increase in the correct responses in pre- and post-KAP questions (1–18) about PV and ADR's reporting with statistical significance (P = 0.0001).

In our study, 35 (35.7%) participants encountered an ADR, but spontaneous reporting was relatively lower, similar result has been shown by other study.[19] ADR and the main reasons for not reporting were pointed out as lack of knowledge about how to report. The above observations point out to the lack of knowledge about reporting system as one of the causes of underreporting. Similar observations were also reported in other studies.[20],[21],[22]

These findings suggest the need for interventions to improve the KAP of the healthcare professionals. Continued practical training about PV might help to solve this emergent problem of underreporting of ADRs. A regular simulated environment and workshop on PV should be conducted for the nursing staff, and periodic interaction should be done to know the problems they are facing. Repeated visits to the AMC center to observe its functioning will help them to understand the different aspects of ADR reporting.

  Conclusion Top

Our study suggested that though there is insufficient knowledge and awareness about PV among nurses, they were eager to learn about ADR reporting. Like other studies, the main reason for underreporting of ADRs was found to be gaps in knowledge. Having continued educational program during their undergraduate period and afterward might provide a solution to strengthen ADR reporting in India. The reporting of ADRs using the relevant forms should be demonstrated and assigned to nurses such as other practical procedures. The results of the present study demonstrate that an educational intervention can increase awareness of PV, ADR's reporting. This gained knowledge would thereby help the nurses during their everyday patient interaction and better patient care. Further, making ADR reporting mandatory can make health professionals aware of the importance of PV in India.

Limitations of the study

  1. The study could not verify the change in the practice of the study population due to time restrictions
  2. The outcome of this study cannot be generalized to all health-care professionals; more studies need to be carried out with larger and boarder study group.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

  References Top

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998;279:1200-5.  Back to cited text no. 1
Nebeker JR, Barach P, Samore MH. Clarifying adverse drug events: A clinician's guide to terminology, documentation, and reporting. Ann Intern Med 2004;140:795-801.  Back to cited text no. 2
Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:14.  Back to cited text no. 3
Alhat BR. Pharmacovigilance: An overview. Int J Res Pharm Chem 2011;1:968-74.  Back to cited text no. 4
Shukla SS, Gidwani B, Pandey R, Rao SP, Singh V, Vyas A. Importance of pharmacovigilance in Indian pharmaceutical industry. Asian J Res Pharm Sci 2012;2:4-8.  Back to cited text no. 5
Gosh AK, De A, Bala NN. Current problems and future aspects of pharmacovigilance. Int J Pharm Bio Sci 2011;2:15-28.  Back to cited text no. 6
Johnson JA, Bootman JL. Drug-related morbidity and mortality. A cost-of-illness model. Arch Intern Med 1995;155:1949-56.  Back to cited text no. 7
World Health Organization. Safety of Medicines: A Guide to Detecting and Reporting Adverse Drug Reactions. WHO/EDM/QSM/2002. Geneva, Switzerland: World Health Organization; 2002.  Back to cited text no. 8
Pharmacovigilance Programme of India. Available from: http://www.ipc.gov.in/PvPI/pv_toolkit1.html. [Last accessed on 2016 Feb 14].  Back to cited text no. 9
Vallano A, Cereza G, Pedròs C, Agustí A, Danés I, Aguilera C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005;60:653-8.  Back to cited text no. 10
Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Saf 2009;32:19-31.  Back to cited text no. 11
Agarwal R, Daher AM, Mohd Ismail N. Knowledge, practices and attitudes towards adverse drug reaction reporting by private practitioners from Klang Valley in Malaysia. Malays J Med Sci 2013;20:52-61.  Back to cited text no. 12
Alan S, Ozturk M, Gokyildiz S, Avcibay B, Karataş Y. An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian J Pharmacol 2013;45:616-8.  Back to cited text no. 13
[PUBMED]  [Full text]  
Rajesh R, Vidyasagar S, Varma DM. An educational intervention to assess knowledge, attitude, practice of pharmacovigilance among healthcare professional in an Indian tertiary care teaching hospital. Int J Pharm Tech Res 2011;3:678-92.  Back to cited text no. 14
Hema NG, Bhuvana KB, Sangeetha. Pharmacovigilance: The extend of awareness among the final year students, interns and postgraduates in a government teaching hospital. J Clin Diagn Res 2012;6:1248-53.  Back to cited text no. 15
Praveen S, Jai Prakash R, Manjunath GN, Gautham MS, Kumar N. Adverse drug reaction reporting among medical and dental practitioners: A KAP study. IJMS 2012;4:10-5.  Back to cited text no. 16
Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res 2011;2:129-36.  Back to cited text no. 17
  [Full text]  
Ekman E, Bäckström M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol 2009;65:43-6.  Back to cited text no. 18
Şencan N, Altınkaynak M, Ferah I, Özyıldırım A, Ceylan E, Clark P. The knowledge and attitudes of physicians and nurses towards advers event reporting and the effect of pharmacovigilance training: A hospital experience. Hacettepe Univ J Fac Pharm 2010;30:24-40.  Back to cited text no. 19
Hanafi S, Torkamandi H, Hayatshahi A, Gholami K, Javadi M. Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting. Iran J Nurs Midwifery Res 2012;17:21-5.  Back to cited text no. 20
Hardeep, Bajaj JK, Kumar R. A survey on the knowledge, attitude and the practice of pharmacovigilance among the health care professionals in a teaching hospital in North India. J Clin Diagn Res 2013;7:97-9.  Back to cited text no. 21
Karelia BN, Piparava KG. Knowledge, attitude and practice of pharmacovigilance among private healthcare professionals of Rajkot city. Int J Basic Clin Pharmacol 2014;3:50-3.  Back to cited text no. 22


  [Table 1], [Table 2], [Table 3]

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