Impact of educational intervention and reinforcement on adverse drug reporting by nursing students: A prospective follow up study

Manisha Bisht; Puneet Dhamija; Bhomik Goel; Vasantha Kalyani; Shailendra S Handu

doi:10.4103/jphpc.jphpc_19_20

ORIGINAL ARTICLE

Year : 2020 | Volume : 1 | Issue : 1 | Page : 36-42

Impact of educational intervention and reinforcement on adverse drug reporting by nursing students: A prospective follow up study

Manisha Bisht¹, Puneet Dhamija¹, Bhomik Goel¹, Vasantha Kalyani², Shailendra S Handu¹
¹ Department of Pharmacology, AIIMS, Rishikesh, Uttarakhand, India
² Assistant Professor (Medical Surgical Nursing) College of Nursing, AIIMS, Rishikesh, Uttarakhand, India

Date of Submission	28-Nov-2020
Date of Acceptance	16-Dec-2020
Date of Web Publication	31-Dec-2020

Correspondence Address:
Dr. Manisha Bisht
Department of Pharmacology, AIIMS, Virbhadra Road, Rishikesh - 249 203, Uttarakhand
India

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jphpc.jphpc_19_20

Abstract

Objectives: This study aimed to evaluate the improvement in knowledge, attitude and practice (KAP) towards the reporting of adverse drug reactions (ADRs) with an educational intervention and the practice of ADR reporting with repeated reinforcement. Methodology: This prospective follow-up study included nursing students in B.Sc. final year attending clinical postings in a tertiary care teaching hospital which is a regional ADR monitoring center. The validated predesigned KAP questionnaire was used to assess the participants pre and post educational session. After the session, students were randomly distributed in to two equal groups (26 each) by computer generated random sequence – Group A (Reinforcement group) and Group B (Control group). Group A was followed up every week till completion of their clinical posting of two months and students were reminded to report adverse event whereas the other group (Group B) was not followed up. The number of adverse drug reports received from the nursing students were recorded during the study period. Results: A total of 52 nursing student participated in the study. There was significant improvement in the knowledge and attitude in the study participants after the educational intervention. There was a significant increase in ADR reporting in post educational session group. (Nil vs 15%, P value < 0.005) and strikingly all the adverse reports were submitted by the reinforcement group. Conclusion: Although educational intervention develops the knowledge about pharmacovigilance, but continuous follow up and reinforcement has more impact on the practice of ADR reporting.

Keywords: Adverse drug reaction, educational intervention, KAP study, nurses, pharmacovigilance, reinforcement

How to cite this article:
Bisht M, Dhamija P, Goel B, Kalyani V, Handu SS. Impact of educational intervention and reinforcement on adverse drug reporting by nursing students: A prospective follow up study. J Public Health Prim Care 2020;1:36-42

How to cite this URL:
Bisht M, Dhamija P, Goel B, Kalyani V, Handu SS. Impact of educational intervention and reinforcement on adverse drug reporting by nursing students: A prospective follow up study. J Public Health Prim Care [serial online] 2020 [cited 2023 Mar 25];1:36-42. Available from: http://www.jphpc.org/text.asp?2020/1/1/36/305985

Introduction

Pharmacotherapy is an integral part of modern medicine. The flip side of drug therapy is adverse drug reactions (ADRs). Approximately 2.9-5.6% of all hospital admissions are accounted by ADRs and nearly 35% of hospitalized patients experience an ADR.^[1] India with second largest population in the world, accounts for a substantial consumption of drugs. Thus it is pertinent to establish a stringent system of identifying adverse drug reactions at the earliest and develop mechanisms to prevent them, in order to ensure patient safety at low cost. Pharmacovigilance Programme of India (PvPI) was launched in 2010 with the objective to safeguard the health of Indian population. PvPI has come a long way since its inception, as presently more than 175 adverse drug reaction monitoring centres report adverse events to National Coordination Centre in India. However, underreporting of ADRs is a common problem in pharmacovigilance programs and it is seen that only 6- 10% of all ADRs are reported.^[2] Initially only doctors and dentists were allowed to submit ADR reports to these databases.^[3] Later on other healthcare professionals (HCPs) and patients were allowed to report ADRs in anticipation to increase the number and quality of ADR reports.^[3]

Hospital nurses play an important role in patient care and may play an important role in ADR reporting. They are often in close contact with the patients for a longer duration and are responsible for drug administration and recording side effects. Given their unique responsibility, a nurse is usually the first person to monitor the patient's response to drugs. Therefore, it is important to involve nurses and motivate them to contribute in ADR reporting system.

In India, PvPI assessment revealed that 64.66% of Individual Case Safety Reports (ICSRs) were reported by Clinicians, 14.75% by Pharmacists whereas reporting by other healthcare professionals including Nurses, Dentist was only 18.83%. Keeping this in mind, National Coordination Centre (NCC) in 2014 took rigorous steps to promote the participation of nursing professionals in PvPI. This study was therefore planned to investigate whether nursing students had better knowledge, attitude, and practice (KAP) towards the reporting of ADRs post intervention before training and evaluate the practice of ADR reporting with repeated reinforcement after educational intervention as compared to educational intervention alone. The main hypothesis behind this study was to assess the practice of ADR reporting in nursing students when it was reinforced by regular training.

Methodology

This pilot interventional study was conducted in a tertiary care teaching hospital in Uttarakhand, which is a Regional ADR monitoring center (AMC), after due approval from Institutional Ethics Committee. The pilot study was conducted between February and July 2017, on the first batch of nursing students when they were undergoing clinical postings in hospital in final year B.Sc. nursing course. The details of all the students was obtained regarding their clinical posting schedule. The batch had 60 students but 54 were available to participate in the study and out of which only 52 participants completed the study. [Figure 1] represents the study design. The KAP questionnaire survey was administered to the student prior to an educational intervention on pharmacovigilance in February 2017. During this educational intervention, the nursing students were encouraged to report all suspected ADRs, including those that were mild or anticipated. The students were then randomly distributed into two equal groups (26 each) by computer generated random sequence – Group A (Reinforcement group) and Group B (Control group). Group A was followed up every week till completion of their clinical posting of two months and students were reminded to report adverse event whereas the other group (Group B) was not followed up. After the completion of the final year exam in July 2017, the nursing students were again administered a survey questionnaire.

Figure 1: Representation of the study design

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The study tool was a predesigned questionnaire adapted from previous studies with some changes to adapt to local conditions.^[4],[5] The survey KAP questionnaire consisted of 18 items. 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 towards PV. The third part (Question No. 14–18) contained set of questions to assess their practice of PV. An open ended question was also included to elicit suggestions on the possible ways to improve the ADR reporting. The questionnaire was anonymized to avoid any potential bias.

The number of adverse drug reports received from the nursing students were also recorded during the study period. Fischer's exact test was used to compare the awareness, attitude, and practice of pharmacovigilance of the nursing student before and after the educational program to evaluate the impact of educational intervention on them. The level of statistical significance was set at p< 0.05.

Results

Fifty-four nursing students were approached to participate in study. The response rate was 96% as 52 participants completed and returned the questionnaire. The survey questionnaire was analyzed question wise and the percentage value were calculated.

Knowledge of nursing students

The knowledge of the nursing students before and after attending the educational intervention on pharmacovigilance is compared in [Table 1]. The results revealed that the nursing students have improvement in knowledge related to pharmacovigilance after attending the educational intervention. More nursing students in the post educational intervention (56% vs 13%, P value = 0.0003) encountered ADRs during their clinical practice and were aware of drugs banned due to ADR. More than 80% nursing students in both the pre and post educational intervention groups were aware that nurses were qualified to report adverse reactions to drugs, while pharmacists and physiotherapists were the least considered to report an ADR. More than 85% nursing students in both pre and post educational intervention were aware of the existence of PvPI. Similarly, more than 80% nursing students in both pre and post educational intervention were aware of the AMC in the institute. Most of the nursing students in both the group were not aware that adverse effects due to topical agents and herbal medications also have to be reported.

Table 1: Knowledge of the nursing students of before and after the educational intervention regarding pharmacovigilance (n=52)

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Attitude of nursing students

The attitude of the nursing students after attending the educational intervention on pharmacovigilance with that prior to attending it is compared in [Table 2]. The main purpose of pharmacovigilance according to the nursing students in both the groups was to identify new ADRs followed by the identification of safe drugs. In both the groups, most respondents were encouraged to report ADRs if the reaction was to a new product or due to seriousness of the ADRs. In the post educational intervention group, most respondents were encouraged to report ADRs if the reaction was correctly diagnosed (96% vs 48%, P value < 0.0001). [Figure 2] represents the major reasons for not reporting of ADR by nursing intern in both the pre and post educational intervention group.

Table 2: Attitute of the nursing students of both the groups regarding pharmacovigilance (n=52)

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Figure 2: Graph showing the factors discouraging the ADR reporting among the nursing student in both groups (n = 52). *P < 0.05, ^#P < 0.0001

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In the post educational intervention group, the notion that reporting may be wrong was (94% vs 54%, P value < 0.0001), was the most important reason which discouraged the nursing students from ADR reporting. In contrast, unawareness of the reporting center (96% vs 38%, P value < 0.0001) was the most important discouraging factor in ADR reporting among nursing intern prior to educational intervention. Most nursing students in both the group (42%, 75%) were of the opinion that ADR reporting is a professional obligation for them.

In post educational intervention group majority of nursing students opined that all serious ADRs should be reported (98% vs 54%, P value < 0.0001), whereas most nursing students in both group felt that all new ADRs should be reported (94%, 96%). Most of the nursing students in both the groups (87% and 96%) especially post educational intervention group felt that ADR reporting should be compulsory.

Practice of nursing student

The comparison of practice of pharmacovigilance in the nursing students post educational intervention with that of pre educational session is given in [Table 3]. Interestingly majority of nursing students in both the groups did not report any ADR (100% vs 85%), even when they admitted encountering ADR during their clinical practice. There was slight but significant increase in ADR reporting in post educational intervention group. (Nil vs 15%, P value < 0.005).

Table 3: Attitude of the nursing students of both the groups regarding pharmacovigilance (n=52)

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Majority of nursing students in the post educational intervention group admitted that the information on the ADR reporting form was clear as compared to the nursing students in pre educational intervention group (46% vs 19%, P value < 0.0001). Most of the nursing students in both the groups felt the need for training on filling of ADR reporting form. Regarding the mode of reporting ADRs, the nursing students in both the groups preferred direct contact e-mail followed by telephone.

[Figure 3] demonstrates the comparison of the reporting of ADR between the two -groups A and group B in our institute from February 2017 – July 2017. All the adverse reports were submitted by Group A (Reinforcement group).

Figure 3: Comparison of the reporting of ADR between the two -groups A and group B in our institute from February 2017 – July 2017 (n = 26)

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Few suggestions were given by the study participants for improving ADR reporting. These included increasing awareness about ADR monitoring and simplifying the process of reporting. It was also suggested that assistance in the reporting the ADRs should be provided.

Discussion

Pharmacovigilance program was started in India in 1986 and later reintroduced by Ministry of Health and Family Welfare, Government of India as Pharmacovigilance Program of India (PvPI) in July 2010.^[6] Continuous efforts are being made to strengthen the PvPI by including more and more MCI recognized medical colleges in this program. This study was conducted in a tertiary care teaching hospital after the pharmacovigilance regional resource center was established in the institute. This pilot study was conducted on nursing student in final year B.Sc. nursing course when they were posted in clinical department in hospital. It was a pilot cross sectional questionnaire based study, comparing the level of knowledge, attitude, and practice of pharmacovigilance in nursing students before and after attending the educational intervention on pharmacovigilance and comparing the reporting of ADR thereafter. The main hypothesis behind this study was to assess the practice of ADR reporting in nursing students when it was reinforced by regular follow up.

This study highlighted that the nursing students have significant increase in the knowledge regarding pharmacovigilance after attending the educational intervention on pharmacovigilance. More nursing students in the post educational intervention were able to identify ADRs during their clinical practice which was promising finding as the first step of pharmacovigilance is suspecting an ADR. Various studies have demonstrated that educational intervention leads to increased awareness regarding pharmacovigilance.^[5],[7],[8] Therefore, appropriate education and training programs are required at regular intervals for increasing the awareness of pharmacovigilance and ADR reporting.

The nursing student in our study even before attending the educational intervention were aware of PvPI and AMC in the institute and knew that they can report ADR. This was in contrast to other previously reported studies which showed that nurses had poor knowledge about ADR reporting system, they knew very less about the purpose of pharmacovigilance and its usefulness.^{[7],[9],[10],[11]} This can be attributed by the fact that these students were taught about pharmacovigilance in their second year during pharmacology lectures hence there was better awareness about the purpose of pharmacovigilance as compared to other studies.

Most respondents, in both the groups, were encouraged to report ADRs if the reaction was to a new product or due to seriousness of the ADRs. The number of students who felt that all ADRs should be reported nearly doubled in post educational intervention. This reflects that the need to report all ADRs can be emphasized by educating the nurses and they may be willing to report all ADRs if adequate knowledge is imparted to them.

The most common discouraging factor for ADR reporting in nursing student prior to educational intervention was the lack of knowledge on where to report indicating lack of awareness in 96% of nursing students. Even though the nursing students were aware of presence of AMC in the institute but did not knew about where to report. As reported in other studies also, there was significant improvement in this factor as more than 62% were aware about how to report in pharmacovigilance center after attending the educational intervention.^[7],[10] There was a passive attitude towards ADR reporting in nursing students of both the pre and post educational group that an unreported case does not affect ADR database. Similar laidback attitude for ADR monitoring has been reported in other studies also.^[7],[9],[10] This highlights the issues which need to be emphasized frequently as it can significantly influence the ADR reporting.

The nursing students in pre educational group were more willing to report to new and serious ADR, whereas nurses in post intervention group were keen to report ADR with correct diagnosis and new ADR. The nursing student were more concerned with correct diagnosis of ADR. This again emphasizes the need to address that the fear of wrong diagnosis is irrelevant as casualty assessment of the ADR is done at AMC and role of reporter is to only provide the information.

80% nursing students in post educational intervention group felt the need to report all ADR as compared to 38% in pre educational intervention group. This highlights that emphasizing the need to report all ADRs in the educational intervention can encourage nursing students to report all ADRs. Most of the nursing student in both the group were of the opinion that the identity of the reporter should be hidden, had a positive attitude towards ADR monitoring. This positive attitude is also reported in other studies.^[7],[9],[10] In this study, more nursing student in the post educational intervention as compared to pre educational intervention encountered ADRs (54% versus 13%) and the number of nursing students who had ever reported ADR were also more in post educational intervention. (15% versus no reporting). Various studies have reported that even though health care professional felt the need of ADR reporting practically most of them fail to report ADR.^[4],[12] This reveals that even though educational intervention can facilitate awareness of ADR reporting, more effort is required to influence the practice of ADR reporting. (M) Few countries like UK, France, Netherlands and Sweden have well established ADR monitoring system and ADR reporting is mandatory. In Sweden for instance, nurses play a very important role in Pharmacovigilance and they also form part of the reporting team. Consequently, ADR reporting rates are much higher in these countries ranging from 40 to 70%.^{[4],[12],[13]}

In this study, even though educational intervention was able to instill adequate knowledge and the right attitude about ADR reporting in the nursing students, putting that into practice was still negligent in both groups. The increase in the number of ADR reports after the educational intervention was seen only in Group A (Reinforcement group) and no ADR were reported from Group B (control group). The most important disclosure of this study was that continuous motivation and follow up with the nursing students was more effective in encouraging them for ADR reporting as compared to the just educating them about the need and importance of pharmacovigilance [Figure 3].

Previous studies have reported that the effect of single educational intervention is usually temporary.^[8] Promoting a culture of voluntary ADR reporting amongst health care professional is a challenging task. Some studies have used interventions such as e-mails, advertisements, verbal reminders, articles in staff newsletters, oral presentations and coordination between healthcare professionals and pharmacovigilance center to increase ADR reporting rate.^{[14],[15],[16]} The need of pharmacovigilance and practice of ADR reporting should be incorporated in the pharmacology teaching and training curriculum. Besides this, continuous follow up subsequently during clinical postings and frequent workshop should be carried out to explain the reporting procedures. The major aim should be to inculcate the habit of ADR reporting during routine patient care.

Lack of time was reported as the most unfavorable factor for ADR reporting. Therefore, providing an easy and quick method of reporting will be major factor in reinforcing the practice of pharmacovigilance. Various interventions are being used for facilitating ADR reporting like introduction of toll free number, email and recently mobile app is also developed.^[17] The major focus is to develop reporter friendly system for ADR Reporting. Apart from this, the majority of nursing students were also concerned about the incorrect identification of ADR and it was the one of the major factor hindering the reporting. This issue can be addressed in follow up educational activities which should be tailored made according to the specific issue identified in the target group.

Previously, many studies have been carried out in India as well as abroad to assess the KAP of nurses regarding ADR monitoring.^{[7],[9],[10],[11],[18]} This study was a step further where we tried to assess the impact of educational intervention on the KAP of pharmacovigilance in nursing students and also tried to assess the strategy of improving the practice of ADR reporting after the intervention. There are few limitations of our study such as less number of study participants and shorter duration of follow up.

Most significant conclusion of this study was that although educational intervention develops the knowledge about pharmacovigilance, but continuous follow up and motivation has more impact on the practice of ADR reporting. This study opens new possibilities for further research for the assessment of effect on integrating pharmacovigilance as a part of curriculum and develop various approaches in improving the practice of pharmacovigilance.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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