Knowledge, attitude and practices about pharmacovigilance activities among hospital nurses: a multicentre cross-sectional survey

Abstract

Background:

The national pharmacovigilance (PV) system has been established in many countries worldwide following the thalidomide tragedy. Nurses have an important role in recognising and reporting any Adverse Drug Reaction (ADR); however, their role has not been widely explored, particularly in Southeast Asian countries.

Aims:

To assess the knowledge, attitudes and practice (KAP) about PV activities, along with barriers and facilitators that affect ADR reporting among hospital nurses in Malaysia. The present study also explores the relationship between demographic characteristics and predictors of KAP among hospital nurses in Malaysia.

Methods:

A multicentre, questionnaire-based, cross-sectional study was conducted in March–May 2021, among nurses working at tertiary care hospitals in Malaysia.

Results:

The mean KAP score of study participants was 57 ± 11. Overall participants had poor ADR knowledge (37.4%), and poor reporting practices (48.9%). Age >30 years (AOR = 2.7 (1.13–6.8), p = 0.02), and working experience of greater than 10 years (AOR = 2.44 (1.08–5.52), p = 0.03), were significantly associated with good ADR knowledge and reporting practices among study participants.

Conclusions:

In summary, study findings offer valuable insight for developing targeted interventions and formal training to improve nurses’ ADR knowledge and reporting practices. Addressing gaps in these areas can enhance patient safety and overall healthcare quality.

Background

The pharmacovigilance (PV) programme has played a major role in detecting adverse drug reactions (ADRs). PV is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems (World Health Organization, 2002).

The success of the PV programme, however, principally relies on the rational use of medicine which dictates an ethical burden on the shoulders of doctors, nurses and all healthcare professionals (HCPs; Bhagavathula et al., 2016). This is important to ensure that the most appropriate treatment prescribed to the patients is to prevent them from being affected by unnecessary harm and risks of pharmacotherapy (Mann and Andrew, 2014). Over time, many studies have been conducted worldwide to assess knowledge, attitude and practice (KAP) about ADR reporting and PV activities among HCPs, especially in developing countries such as India, Saudi Arabia and Malaysia (Alshammari et al., 2015; Gupta et al., 2015). These studies reflected inadequate knowledge and unsatisfactory attitudes and practices among the HCPs on ADR reporting that contributed to the failure in reporting an ADR even if the ADR was identified during post-marketing surveillance. Most of the HCPs involved in these studies were physicians and pharmacists. Few studies focusing on nurses concluded that there were gaps in the nurses’ knowledge and awareness of the existence and functions of the PV (Adisa and Omitogun, 2019; Hussain et al., 2021). Nurses hold an exclusive position in drug administration, closely monitor patients’ responses to drugs and are often the eyes and ears in alerting the responsible physician or pharmacist about possible ADRs experienced by the patients in the hospital setting (Hanafi et al., 2012). Thus, it is essential to optimise PV knowledge among nurses to formulate strategies that can improve ADR reporting (Paudyal, 2018). Until now, there are no data available and studies mentioning PV KAP among hospital nurses in Malaysia. This study is vital to fill the data scarcity; in addition, it will also help in understanding the local hospital nurses’ behaviour, beliefs and practices about the PV programme thus enforcing better trends for PV practices among nurses and improving the overall safety of patients. The purpose of this study was to assess the knowledge, attitudes and perceptions about PV activities, along with barriers and factors that encourage ADR reporting, demographic factors affecting KAP predictors among hospital nurses in Malaysia.

Operational definitions

• PV programme: The PV programme encompasses a range of activities and processes aimed at detecting, assessing, understanding and preventing adverse effects or any other drug-related problems (World Health Organization, 2023).

• PV system: This refers to the framework used by the registration holder that includes all the elements necessary for monitoring and managing drug safety listed in PV rule (Drug Regulatory Authority, 2022).

• PV activities: These activities refer to the group of tasks and processes carried out by the system to achieve the goals specified in the PV rule is referred to as PV activities (Drug Regulatory Authority, 2022).

• Adverse drug reaction: An ADR is characterised by an unpleasant and inadvertent reaction to a medication that happens at dosages typically administered to humans for the prevention, diagnosis or treatment of illness, or for alterations in physiological function (Center for Medication Safety, 2006).

• ADR reporting: It refers to the process of systematically gathering, recording and submitting data on adverse drug reactions to regulatory agencies, pharmaceutical firms or other pertinent authorities responsible for PV (BMA Board of Science, 2006).

Methods

Study design

This was a multicentre, questionnaire-based, cross-sectional study conducted among nurses working in Malaysian hospitals between March and May 2021. Cluster sampling was used to randomly select hospitals in this study. Firstly, a list of 37 tertiary-care public hospitals from 13 states and three federal territories in Malaysia was made and assigned to a sequential number. Then, at least one hospital from each state was randomly selected using a random number generator (Random.org., n.d.). A total of 15 public tertiary care hospitals were selected for this study using random number generator (Random.org., n.d.). The sample size required for this study was calculated by using Raosoft online sample size calculator.

$$x=Z{(c/100)}^{2}r(100-r)$$

$$n{=}^{\mathrm{NX}}/{(}^{\mathrm{N}-1)}{E}^2{+}^{\mathrm{X}})$$

$$E=\surd {[}^{(\mathrm{N}-\mathrm{n})\mathrm{x}}{/}_{\mathrm{n}(\mathrm{N}-1)}]$$

where, n is the sample size, N is the population size, E is the margin of error, r is the response distribution and Z(c/100) is the critical value for the confidence level c.

By using E of 5%, r of 50% and Z(c/100) = 1.96 at a confidence level of 95%, the calculated n is 377 nurses.

Oversampling by 10% of the actual sample size calculated by Raosoft online calculator was done to get the final calculated sample size. This is because to take into consideration that approximately 10% of participants can be expected to drop out of the research studies. Therefore, for this study, the finalised calculated n was 377 × 10% = 414 nurses.

Participants were included in this study based on these criteria: (a) Ministry of health (MOH) hospital nurses registered with Nursing Board Malaysia and, (b) Working full-time in tertiary care Malaysian hospitals (as they are directly involved in patient care and interaction with physicians and other healthcare workers, thus playing an integral role in identifying and recognising ADR). MOH hospital nurses who were on leave or absent from work during the recruitment period were excluded from the study. Nurses for this study were selected from 15 public tertiary care hospitals using convenient sampling. The link of the Google form was distributed to all full-time nurses in each hospital through designated liaison officers. Only forms received within the specified study period (March–May) were considered for inclusion.

Data collection tool and scoring system

A standardised data collection form with a Cronbach’s alpha of 0.72 (Hussain et al., 2021) was utilised in this study. The questionnaire was in English and comprised six main parts detailed below. The originality of the questionnaire was maintained in this study.

• (i) Demographics section includes data on participants’ age, gender, their highest qualification and the number of years of practicing in the hospital setting.

• (ii) Knowledge section contains 11 questions which were divided into two sub-parts to assess participants’ knowledge about ADR and PV activities. The respondents were expected to answer these items in the form of ‘yes’, ‘no’ or ‘don’t know. The knowledge was assessed by giving the value of 1 to a correct answer and 0 to a false answer. The ‘don’t know’ response was also assigned 0 scores.

• (iii) Attitude section contains 13 items to explore the positive or negative influence on the nurses’ attitudes towards ADR reporting. The attitude response was rated using 5-point Likert scale ranging from strongly agree to strongly disagree. The attitude score was calculated by giving values 1 to ‘strongly disagree’ and 5 to the ‘strongly agree’ response. Reversed scoring was utilised for negative questions.

• (iv) Practice section contains 10 items that were sub-divided into two sub-parts to explore the practices of hospital nurses towards ADR reporting. The first sub-part was related to the practices regarding reporting ADR and the second sub-part is related to the mode of ADR reporting. The respondents were expected to answer these items in the form of ‘yes’ or ‘no’. The practice score was assessed by giving a value of 1 for the correct answer and 0 for the wrong answer.

• (v) Barrier section comprised of 11 items to identify the barriers to ADR reporting in the hospital setting.

• (vi) Facilitator section contains five factors and possible methods that might encourage ADR reporting. Responses for barriers and facilitators section were collected using 5-point Likert scale (where: 1 = ‘strongly agree’, 2 = ‘agree’, 3 = ‘neutral’, 4 = ‘disagree’, 5 = ‘strong disagree’).

• Bloom’s cut-off points were used for the categorisation of nurses based on their KAP where participants with 80–100% scores ranked as good knowledge, positive attitude and good practice holders, 60–79% moderate, whereas <60% were considered poor knowledge, negative attitude and poor ADR reporting practices scorers, respectively (Hu et al., 2022).

Pilot testing and reliability of the survey questionnaire

Pilot testing was done before the implementation of an actual survey by distributing the questionnaire to 30 MOH hospital nurses and responses obtained from these nurses were excluded from the final study. The internal consistency and reliability of the questionnaire were calculated by using Cronbach’s coefficient. The internal consistency of the questionnaire used in this study was 0.96.

Data collection procedure

The self-administered questionnaire was converted into Google form and its link was distributed via WhatsApp through an appointed liaison officer in each hospital. When the participants clicked on the link of the Google form, a statement about the research project and the consent form appeared. By clicking the ‘agree’ button on the informed consent form, nurses voluntarily agree to participate and were consequently directed to the other parts of the questionnaire. The questionnaire took about 5–10 minutes to be completed and the responses were kept anonymous. The questionnaire took about 5 minutes to be completed and the response from the participants was totally anonymous. Data collected were saved in the form of Excel table generated from the Google form. Data were only accessible to the principal and co-investigators. Data remained anonymous, downloaded and kept in a computer that was password protected. On completion of this study, data in the computer were copied to CDs and the data in the computer were erased. The CDs and any hard copy data were stored in a locked office of the principal investigator and maintained for a minimum of 3 years after the completion of the study. The CDs and data will be destroyed after that period of storage. Participants were not allowed to view their personal study data, but they can write to the investigators to request access to study findings.

Data analysis

All data from the participants were analysed using the Statistical Package for the Social Sciences software Version 25 database. Descriptive statistics were used for demographic variables; mean and standard deviations were used to express the continuous variables while percentages and frequencies were used to express the categorical variables. The Kolmogorov–Smirnov test was used to assess the normality of the data. As data follows non-normal distribution (p-value of <0.05 produced on normality testing), non-parametric tests were used for the interpretation of results. The Kruskal–Wallis test was used to explore the relationship between participants’ characteristics, and their KAP level followed by the post hoc Dunn test to determine the difference between pairs. Binary logistic regression analysis was performed to identify the factors associated with the participant’s good knowledge, positive attitude and good practices in reporting ADR. All variables that showed statistical significance in the bivariate analysis with a p-value ⩽0.25 were entered into a multivariable logistic regression model to determine independent factors associated with good KAP among study participants. A p-value of less than 0.05 was considered statistically significant for all tests.

Results

Demographic characteristics of participants

Google form link was distributed to 430 nurses by the liaison officer, and a total of 409 tertiary-hospital nurses took part in this study. The questionnaire was returned to the researcher with a response rate of 95.1%. Out of 409 nurses participated, majority were females (n = 385, 94.1%), with a mean age of 36.0 years. The majority were diploma holders (n = 378, 92.4%) and had a job experience of more than 20 years (n = 53, 13.0%). Overall participants had poor ADR knowledge (37.4%) and poor reporting practices (48.9%). However, a positive attitude was recorded from study participants that considered a positive sign in improving ADR reporting among nurses (Figure 1).

Figure 1.

Nurse’s level of knowledge, attitude and practice (n = 409).

Demographics of study participants are described in Table 1.

Table 1.

Sociodemographic characteristics of Nurses (n = 409).

Category	Subcategory	N (%)*
Gender	Male	24 (5.9)
	Female	385 (94.1)
Age (years)	21–25	15 (3.7)
	26–30	87 (21.3)
	31–35	119 (29.1)
	36–40	82 (20.0)
	41–45	56 (13.7)
	45 and above	50 (12.2)
Mean ± SD	36.0 ± 7.4
Qualification	Diploma	378 (92.4)
	Degree	12 (2.9)
	Specialisation	2 (0.5)
	Others; Certificate	17 (4.2)
Working experience (years)	5 years or below	61 (14.9)
	6–10 years	152 (37.2)
	11–15 years	75 (18.3)
	16 20 years	68 (16.6)
	20 or above	53 (13.0)
Mean ± SD	11.7 ± 7.1

^*The percentages were calculated in the total number of respondents (n = 409).

Knowledge about ADR reporting and PV activities

Although most nurses who participated in this study accurately defined an ADR (n = 344, 84.1%), most of them thought that all serious ADRs are ‘Known’ before a drug is marketed, which was incorrect (n = 280, 68.5%). More than half (n = 249, 60.9%) knew that ADRs should be reported even if uncertain about the medicine that caused the adverse effect. However, they responded incorrectly that ADRs, which are previously documented by manufacturers, need not to be reported again (n = 185, 45.2%).

As for knowledge about PV systems and activities, 65.3% (n = 267) of nurses were fully aware of the definition of PV. Most of the nurses (n = 362, 88.5%) responded correctly that the most important purpose of PV is to ensure the safety of drugs. More than half (n = 260, 63.6%) also knew about the existence of ‘Vigibase’ online database for reporting ADR by WHO. However, most of them did not know that the international centre for ADR monitoring is located in Sweden (n = 243, 59.4%). More than half of the participants (n = 268, 65.5%) were aware of the existence of the PV programme in Malaysia. Most of them responded correctly that the national centre for adverse drug reaction monitoring is responsible for the monitoring of ADR in Malaysia (n = 320, 78.2%), and they also knew that recent guidelines had been established for ADR reporting by the MOH (n = 334, 81.7%). Supplemental Table S1 illustrates participants’ knowledge regarding ADR reporting and PV activities (see Supplemental File).

Attitude towards ADR

The positive or negative influence on the nurses’ attitudes towards ADR and its reporting were explored using a 5-point Likert scale. More than half of the nurses (n = 235, 57.5%) firmly believed that ADR reporting is an important activity to improve the safety of medicines. One-fifth (n = 85, 20.8%) of the participants strongly agreed that it is necessary to report only serious and unexpected reactions, but almost similar proportions (n = 83, 20.3%) strongly disagreed with it. Moreover, 37.9% (n = 155) strongly believed that information on reporting ADR should be taught during the internship, training or clinical posting. Most of the nurses (n = 128, 31.3%) agreed that they are the most important HCP to report ADR and 31.5% (n = 129) agreed that reporting ADR is a professional obligation. Besides, many of them (n = 131, 32.0%) strongly agreed that consulting colleagues and other HCP is important before reporting ADR. They (n = 139, 34.0%) agreed it is necessary to confirm that ADR is related to a particular drug before reporting it to the hospital management. Regarding the workplace, 41.3% (n = 169) of them strongly agreed that the workplace should provide information regarding the procedure of reporting ADR and 34.0% (n = 139) agreed that the workplace environment should encourage ADR reporting. Supplemental Table S2 illustrates participants attitudes towards ADR reporting and PV activities (see Supplemental File).

Practices towards ADR reporting and their mode of reporting

When respondents were asked about their practices regarding ADR reporting in hospitals, it was revealed that most of them have never reported an ADR before (n = 298, 72.9%). Only 11.7% (n = 48) of respondents had reported an ADR in the last 12 months.

Concerning the practices towards modes of ADR reporting, most of the nurses acknowledged the availability of all the modes of ADR reporting listed in the questionnaire. Direct reporting to the hospital pharmacy was selected as the most frequently used mechanism to report an ADR by the nurses (n = 334, 81.7%), followed by verbal information (n = 320, 78.2%) and the ADR form (blue form) (n = 262, 64.1%). Among the modes listed, informing the manufacturer is the least used mechanism to report an ADR by the nurses (n = 191, 46.7%). Supplemental Table S3 illustrates participants’ practices towards ADR reporting and PV activities (see Supplemental File)

Differences between demographic characteristics and KAP score towards ADR

Significant differences between nurses’ characteristics and their attitude and practice scores related to ADR reporting were observed in this study. Among these, participants’ age and years of working experience showed significant differences in ADR practice scores (p < 0.05). Participants aged 31–40 and >40 years attained high practice scores as compared to participants in the age group of 21–30 years (p < 0.01). Nurses with years of working experience of more than 20 years achieved high practice scores as compared to participants in other groups (p < 0.001). Attitude score was also significantly higher among subjects with working experience of more than 20 years (median = 51, IQR = 13; p < 0.05). No significant differences were observed in participants’ characteristics and ADR knowledge score (p > 0.05; Table 2).

Table 2.

Nurses characteristics influencing the association with KAP scores calculated for ADR reporting.

	Variable	KAPS (0–86)	p-Value	Knowledge score (0–11)	p-Value	Attitude score (0–65)	p-Value	Practice score (0–10)	p-Value
Gender	Female	61(14)	0.64	7 (4)	0.05	49 (13)	0.60	5 (3)	0.67
	Male	57.5 (20.5)		8 (3)		45.5 (31)		4 (3)
Age	21–30	58 (17)	0.05	7 (4)	0.125	47 (17)	0.13	3 (4)	0.004
	31–40	61 (14)		7 (4)		49 (11)		5 (3) a
	>40	62 (14)		8 (3)		49.5 (16)		5 (3) b
Qualification	Diploma	60 (14.7)	0.60	7 (4)	0.37	48 (14)	0.46	5 (3)	0.74
	Degree	64 (8)		6 (3)		52 (6)		5 (4)
	Specialisation	56.5 (0.0)		7 (0)		46.5 (0)		3 (0)
	Others	63 (29.5)		9 (4)		50 (31)		6 (4)
Years of working experience	<5	55 (26.7)	0.016	7 (4)	0.17	46.5(26)	0.031	3 (4)	0.000
	5–10	61(13) c		7 (4)		49 (13) d		4 (3)
	11–15	61(13)		8(4)		48 (10)		5 (2) e
	16–20	61(17)		8 (2)		48 (17)		5 (3) f
	>20	63 (13.5) g		7(3)		51(13) h		6 (3) i

Post hoc parameter analysis via Dunn test (p < 0.05).

ADR: adverse drug reaction.

^aSignificant difference between 21–30 and 31–40 (post hoc Dunn test p = 0.03)

^bSignificant difference between 21–30 and >40 (post hoc Dunn test p = 0.004)

^cSignificant difference between <5 and 5–10 (post hoc Dunn test p = 0.03)

^dSignificant difference between <5 and 5–10 (post hoc Dunn test p = 0.01)

^eSignificant difference between <5 and 11–15 (post hoc Dunn test p = 0.001)

^fSignificant difference between <5 and 16–20 (post hoc Dunn test p = 0.002)

^gSignificant difference between <5 and >20 (post hoc Dunn test p = 0.013)

^hSignificant difference between <5 and >20 (post hoc Dunn test p = 0.015)

ⁱSignificant difference between <5 and >20 (post hoc Dunn test p = 0.005)

Bold values indicates significant finding p < 0.05.

Predictors of nurse’s good KAP level towards ADR

Logistic regression was used to test the association between sociodemographic characteristics of study participants with their good KAP levels. The assumption of multicollinearity among independent variables was tested using the variance inflation factor (VIF). No multicollinearity issue was found among independent variables (VIF <5 observed). The odds of having good knowledge of ADR reporting among nurses aged >30 years was 2.7 times (AOR = 2.7 (1.13–6.8), p = 0.02) higher than participants who were aged less than 30 years. The likelihood of having good ADR knowledge was 1.4 times (AOR = 1.4 (0.16–0.9), p = 0.04) higher among nurses with a working experience of >10 years as compared to nurses with experience of fewer than 10 years. The odds of having good reporting practices were 2.4 times (AOR = 2.44 (1.08–5.52), p = 0.03) higher among nurses with working experience of greater than 10 years as compared to participants with experience of fewer than 10 years. Similarly, nurses having good knowledge of ADR showed good reporting practices as compared to nurses having low knowledge scores (AOR = 1.4 (1.27–1.54), p = 0.001); Supplemental Table S4).

Barriers related to ADR reporting

There were 11 barriers provided in the questionnaire and intriguingly the largest proportion of the nurses responded neutrally to all 11 statements. Among all the neutral responses, most of them (n = 237, 57.9%) felt neutral to lack of financial reimbursement, followed by ADR form being too difficult to fill (n = 219, 53.5%) and fear of legal liability (n = 215, 52.6%). Secondly, to those neutral responses, some of them agreed that lack of knowledge (n = 127, 31.1%), lack of time (n = 103, 25.2%) and lack of confidence in discussing ADR with the prescriber (n = 84, 20.5%) were the factors that discourage them from reporting an ADR (Figure 2).

Figure 2.

Barriers related to ADR reporting among nurses (n = 409).

Responses presented in frequency (n).

Facilitators related to ADR reporting

A 5-point Likert scale was used to identify factors and possible methods that might encourage ADR reporting. Most of the nurses who participated in this study strongly agreed with continuous nursing education and training related to ADR reporting (n = 121, 29.6%), reminders and increased awareness from the ADR monitoring centre (n = 105, 25.7%) and online system for ADR reporting (n = 104, 25.4%) can improve ADR reporting in the hospital setting (Figure 3).

Figure 3.

Facilitators related to ADR reporting among nurses (n = 409).

Responses presented in frequency (n).

ADR: adverse drug reaction.

Discussion

The majority of nurses (84.1%) in our study were able to define an ADR correctly, which was consistent with published studies (Hammour et al., 2017; Vural et al., 2015). Although about 60% of them were aware that ADRs should be reported even if indefinite about the medicine that caused the adverse effect, most of them (68.5%) thought that all serious ADRs are known before a drug is marketed and ADRs, which are previously documented by manufacturers, need not be reported again, which were incorrect. This shows an inadequacy concerning the general knowledge of ADR reporting among hospital nurses. The majority (68.5%) of nurses who participated in our study were most concerned to report reactions to newly introduced drugs in the market. The identical observation was also seen among nurses in published studies where 78% nurses were concerned to report reactions to newly introduced drugs (Su et al., 2010). Spontaneous reporting of ADRs from medicines that are newly marketed is an integral component of the drug safety surveillance programme. The recognition to monitor drugs used in real-life situations from time to time since they are first marketed goes hand-in-hand with the ultimate objective of the PV programme, which is to detect and generate signals indicating potential untoward effects, thus allowing the identification of new and rare ADRs. With no exposure and proper training on PV activities, it is expected that nurses may not be able to define PV correctly. However, in Malaysia, most of the nurses who responded to this study were fully aware of the terminology of PV and its function. Furthermore, more than half were aware of the existence of the PV programme in Malaysia and its monitoring centre. They are also aware of the fact that the PV guideline established for ADR reporting by the MOH, that outlines the requirements and procedures for submission of ADR reports and information regarding product safety to the drug control authority (Haque, 2017). Although not obligatory, product registration holders and HCPs are encouraged to comply with this guideline and document to ensure the safety profile and quality of medicinal products registered in Malaysia (Haque, 2017). These findings convey that Malaysian nurses had a high level of awareness regarding the national PV programme unlike nurses in other developing countries (Hanafi et al., 2012).

Overall a positive attitude towards PV and in particular, ADR reporting was observed among nurses in this study. This is derived from the findings that more than three-quarters agreed that ADR reporting is an important activity to improve the safety of medicines. Besides, more than half believed that they are the most important HCP to report ADR. A large proportion also felt that reporting ADR is a professional obligation and should be mandatory for all nurses. The optimistic attitude of nurses towards ADR reporting has been reported elsewhere in several studies (Hanafi et al., 2012; Hussain et al., 2021). Despite the positive attitude to ADR reporting among nurses who participated in our study, the actual practice of ADR reporting was poor, as more than two-thirds of them had never reported an ADR before and never kept ADR records. Under-reporting of ADR among nurses is apparently a problem worldwide as much literature disclosed low ADR reporting rates ranging from 2.4%, 2.9%, 8.8%, 9%, 14% to 22.8%, respectively (Gupta et al., 2015; Hanafi et al., 2012; Su et al., 2010). The mode of ADR reporting can involve both verbal and non-verbal communication. It is demonstrated by this study that more than 75% of the nurses practised verbally reporting an ADR to either a relevant person or directly to the hospital pharmacy or hospital management. Verbal communications in ADR reporting may cause errors. As reported by a Danish study that reviewed the root cause analyses reports for descriptions and characteristics of verbal communication errors among hospital staff, the study identified that handover errors, misunderstandings, hesitance in speaking up and communication errors between different staff groups were the major contributing factors noted during verbal communications for ADR reporting (Rabøl et al., 2011). By taking this into account, the use of verbal reporting might be perceived to reduce ADR reporting formally among nurses that may explain under-reporting. Nurses who participated in the present study also preferred to directly report ADRs to the hospital pharmacy. It was the most popular mode of ADR reporting selected by the nurses who responded to this study. A similar situation has also seen among nurses working at tertiary-care hospitals in Pakistan (Hussain et al., 2021) and China (Su et al., 2010) where 67.3% of HCPs agreed that pharmacists are chief personnel and should be concerned for the ADR reporting and PV activities (Shamim et al., 2016). Over the years, the profession of the pharmacist has evolved from standard practice as a drug dispenser to extensively shifting towards pharmaceutical care (Hadi et al., 2017). Therefore, pharmacists have an integrating role with other HCPs, especially in the hospital setting to improve ADR reporting as many ADRs occur in a hospital, or could lead to hospitalisations (Su et al., 2010). This shows the positive outcome of the pharmacists’ participation to ensure the safety of drug therapy.

Predictors related to good ADR KAPs were also explored in this study. The findings revealed that years of professional experience significantly associated with the nurse’s good knowledge towards ADR reporting. This finding was consistent with the published study where knowledge of ADR reporting among nurses increased with the increase in years of working experience was observed. The significant association may be explained as nurses who are more experienced might have better opportunity to access updated information, which would help them in improving their knowledge of PV and ADR reporting as compared to nurses with fewer experience (Amsalu et al., 2021). Nurses with a good knowledge score were more likely to have good ADR reporting practices as compared to nurses with poor knowledge in this study. The findings were in line with a published study conducted among nurses in Ethiopia (Wake et al., 2021) where good knowledge scores were positively significantly associated with nurses’ good ADR reporting practices (AOR = 5.35, 95% CI; 1.77, 16.17). Having right and updated information regarding patient safety and ADR reporting would possibly justify the positive effects of knowledge score on the nurses’ reporting practices as they may have full information to practice (Wake et al., 2021).

This study has identified several factors that may prevent nurses from reporting ADR. Almost 60% of the respondents felt neutral about the lack of financial reimbursements barrier in reporting ADR. It is notable from several intervention studies that introducing financial incentives will contribute to the positive effect on ADR reporting (Chang et al., 2017; Pedrós et al., 2009). However, the financial compensation for each ADR reporting can be difficult in resource-poor countries, and its influence can lead to falsification of reports and over-reporting. Hence, the compensation should not be entirely monetised, but the strategy can be included as public commendation and only the annual performance excellence awardees are eligible for financial reward (Ali et al., 2021). Individual-related barrier is another major factor identified that hinders the nurses to report ADR. The barriers are lack of knowledge when ADR happened, lack of confidence in discussing ADR with the prescriber and lack of time to do reporting. As nurses are having difficulties in identifying the signs and symptoms of ADR, they may lose confidence in discussing the ADR with other HCPs, thus leading them to consign the function solely to physicians and pharmacists. It was undeniable that the absence of professional confidence is one of the hindrances to effective reporting of ADRs among HCPs (Ali et al., 2021). Therefore, sufficient knowledge of pharmacology is essential for nurses in clinical settings, focusing on common drugs they administer to boost their credentials in drug administration and safer medicine management (Salehi et al., 2021).

The present study also reported facilitators that would encourage nurses to report ADR. Many nurses agreed that they would report ADR if they got extra time and incentives other than their duty hours. Majorly perceived that training and continuous education and reminders should be provided by relevant authorities to increase their ADR reporting. The availability of an online ADR reporting system may also facilitate them in prompt reporting of ADR. The findings were in line with the published studies where HCPs including nurses addressed similar motivations to report ADR. Hence, future efforts should be made on this account to improve overall reporting practices of ADR among nurses.

Several limitations relied with this study. This study is restricted to nurses working in public, tertiary-care hospitals in Malaysia. Thus, the findings may not be representative of the nurses working in private hospitals in Malaysia. Response bias could be another limitation because some of the questions were relying on the ability of respondents to recall information, such as any ADR identified during their years in practice, which may affect the results in some ways. Since the baseline of the KAP of PV among hospital nurses has been obtained from this study, further studies on assessing their KAP after completing educational activities such as presentations or workshops could be conducted to measure the impact of such programmes in reporting ADR.

Recommendations and their implementation

Findings from the present study call for several recommendations that should be implemented to improve ADR reporting among nurses in Malaysia.

1. Continuous, structured educational and training programmes: Regular workshops and seminars focusing on drug safety and ADR reporting should be organised for nurses, especially for those involved directly in drug administration and patient monitoring. Pharmaceutical firms and healthcare institutions should collaborate to organise online training courses that include PV, ADR recognition and the reporting procedure.

2. Clinical updates and exposure: Constant updates and exposure to knowledge and awareness in the areas such as clinical presentations on new drug products may increase nurses’ clinical knowledge, thus leading to effective ADR reporting and monitoring. This approach could be achieved by inviting experts from relevant fields to share their knowledge and expertise. Clinical updates should also be incorporated in the curricula designed and taught in nursing programmes.

3. Collaboration between educational and healthcare institutions: The educational and healthcare institutions should incorporate each other and support the local HCPs to augment their knowledge and practices towards the safe use of medicines. Integrated programmes that provide practical experience in the real world of healthcare could also aid in reinforcing their theoretical knowledge.

4. Hospital management support: The hospital management should diligently disseminate information on ADR reporting and PV activities. Bulletin boards, intranet platforms and forums for open discussions on medication safety and on ADR reporting and PV activities could be utilised for effective communications.

5. Encourage cross-disciplinary collaboration: Encourage awareness of medicine safety through collaboration across ranks and disciplines mainly with the HCPs, academia and regulatory bodies could also be utilised.

6. National pharmaceutical regulatory agency involvement: Public awareness campaigns and regional workshops in collaboration with national regulatory agencies should also be used to actively promote the importance of PV activities throughout the country, particularly in places where the ADR reporting is seemingly low.

7. No-blame work environment: Hospital management should create and stimulate a no-blame work environment where HCPs can report errors without fear of being reprimanded or punished. This could be achieved by establishing clear policy that promotes the no-blame culture for reporting errors. Implementing confidential reporting systems to protect the identity of the reporting individuals also improves ADR reporting among nurses.

8. Safety culture emphasis: The concept of ‘safety culture’ should also be taught and emphasised to all HCPs starting from the undergraduate level and later in their clinical practice. Regular training sessions, newsletter and leadership messaging could be implemented to emphasise the significance of safety culture of ADR reporting among undergraduates.

Conclusions

Nurses in Malaysia had inadequate knowledge of ADR and poor reporting practices despite high awareness about PV activities. Continuous education, formal training and awareness of PV and ADR reporting are the initiatives that should be considered to encourage and empower nurses’ participation in drug safety surveillance.

Key points for policy, practice and/or research

• Findings of this study suggest that nurses had poor ADR knowledge and reporting practices.

• However, a positive attitude was recorded from study participants which was considered a positive sign to improve ADR reporting in the future.

• Education and training programmes on drug safety and ADR reporting should be organised for nurses.

• Collaborations between healthcare facilities, academic institutions and drug regulatory authorities should be initiated to improve ADR-related practices among nurses.

• Further study on assessing nurses’ medicine safety-related knowledge after completing educational activities such as presentations or workshops could be conducted to measure the impact of such programmes on ADR reporting.

Biography

Mira Marina Mahfodz is a Junior Researcher, with a master’s in Clinical Pharmacy, Discipline of Clinical Pharmacy School of Pharmaceutical Sciences, Universiti Sains Malaysia. Her research interest lies in clinical studies evaluating healthcare practitioners’ knowledge and perception of various aspects of healthcare quality.

Sania Siddiqui is an early-stage Researcher, and clinical research co-coordinator with a master’s in Clinical Pharmacy, Discipline of Clinical Pharmacy School of Pharmaceutical Sciences, Universiti Sains Malaysia, and Aga Khan University Hospital Karachi Pakistan. Her research interest lies in clinical trials, infectious and non-communicable diseases, and studies strengthening the healthcare system by using both qualitative and quantitative research approaches.

Hadzliana Zainal is a Lecturer and coordinator at the Discipline of Clinical Pharmacy School of Pharmaceutical Sciences, Universiti Sains Malaysia with PhD in Clinical Pharmacy from University College London. Her research interest lies in Clinical Pharmacy, pre-clinical, pharmacokinetic, and pharmacodynamic modeling