Knowledge, attitude, and practice of pharmacovigilance among healthcare professionals at a tertiary level hospital, Sudan: a cross sectional study

Abstract

Background

Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality worldwide, reflecting a critical need for effective pharmacovigilance. Pharmacovigilance ensures drug safety by monitoring, assessing, and preventing the occurrence of ADRs. Healthcare professionals are pivotal in this system because of their interactions with patients and medications. Understanding their knowledge, attitudes, and practices toward pharmacovigilance is crucial for identifying gaps and enhancing initiatives for drug safety.

Objective

To evaluate the knowledge, attitudes, and practices of pharmacovigilance among healthcare professionals at Atbara Teaching Hospital, identify the reasons for the underreporting of ADRs, and determine if there is a significant association between pharmacovigilance training and ADR reporting.

Methods

This descriptive cross-sectional study was conducted at Atbara Teaching Hospital via a stratified simple random sampling method. Data was collected using a self-administered questionnaire consisting of demographic data and a knowledge, attitude, and practice section. The data were analyzed via the Statistical Package for Social Sciences (SPSS) to determine associations between various variables.

Results

A total of 122 healthcare professionals participated in the study. The knowledge of pharmacovigilance among the participants was moderate, with a mean knowledge score of 5.1 ± 1.9 out of 12. The definition and primary purpose of pharmacovigilance were correctly identified by 67.2% and 69.7%, respectively, and the definition of adverse drug reaction was identified by 54.1%. Notably, only 23.8% were aware of the existence of pharmacovigilance program in Sudan. The participants showed a generally positive attitude toward pharmacovigilance with a mean score of 7.7 ± 2.0 out of 12. A total of 95.1%, agreed with the necessity of ADR reporting and 79.5% believed that pharmacovigilance should be taught to all healthcare professionals. The practice of ADR reporting was lacking; although 66.4% of the participants had observed an ADR during their professional practice, only 18.9% reported it. This imbalance between the ADR observed and reported was attributed to several barriers, mainly due to unawareness of how and where to report an ADR and the lack of incentives for reporting. The study revealed a significant association between pharmacovigilance training and ADR reporting.

Conclusions

While healthcare professionals exhibited adequate knowledge, and favourable attitudes toward pharmacovigilance, practical reporting rates were low. Targeted training, streamlined reporting mechanisms, and policy interventions are recommended to bridge this gap and enhance drug safety.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12913-025-13364-7.

Introduction

Pharmacovigilance (PV) is a critical component of public health and is defined by the World Health Organization (WHO) as sciences and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems [1]. Its primary goal is to ensure the safety and efficacy of drugs, as improper drug safety can lead to severe consequences, including lifetime disability or mortality [2]. Adverse drug reactions (ADRs), which are noxious and unintended responses to drugs used at normal doses, remain a significant global clinical issue, contributing to substantial morbidity and mortality [3, 4]. Despite rigorous premarketing clinical trials, ADRs persist due to the limited scope of these trials, which may not account for all population groups or unforeseen variables [5]. In Sudan, the National Medicines and Poisons Board (NMPB) serves as the Medicines Regulatory Authority (MRA), which is responsible for ensuring the safety, quality, efficacy, and affordability of medicines [6]. The Pharmacovigilance Center (PVC), established in 2007 under the NMPB, plays a pivotal role in monitoring the quality and safety of medicines postmarketing. The PVC collects and evaluates information on pharmaceutical products, particularly those focused on ADRs, and implements regulatory actions on the basis of its findings [6–8]. Healthcare professionals are central to the success of the pharmacovigilance system, as spontaneous reporting remains the cornerstone of ADR detection and regulatory actions [9, 10]. However, underreporting remains a significant issue and is often attributed to factors such as a lack of knowledge, time constraints, and inadequate training [11–13]. In Sudan, healthcare professionals are encouraged to report ADRs via forms provided by the PVC. This form includes sections on patient details, suspected medicine, suspected ADRs, and reporter information. Completed forms must be submitted to the PVC via email within specified time frames on the basis of severity of the ADR. The PVC processes these reports in compliance with WHO procedures, sharing pertinent data with the Uppsala Monitoring Centre (UMC-WHO) in Sweden, which maintains an international database of ADRs. Despite the critical role of pharmacovigilance in drug safety, there is a notable gap in knowledge regarding whether healthcare professionals in Sudan report ADRs to the PVC and the reasons for underreporting. To date, no studies have been conducted on this subject among healthcare professionals in Sudan, despite its importance. Understanding the knowledge, attitudes, and practices (KAPs) of healthcare professionals toward pharmacovigilance is essential for improving ADR reporting and consequently reducing drug-related morbidity and mortality.

This study aims to assess the KAP of pharmacovigilance among healthcare professionals at Atbara Teaching Hospital in Atbara, Sudan, to identify barriers to ADR reporting and determine whether there is a statistically significant association between pharmacovigilance training and ADR reporting. The findings from this study provide valuable insights into the current state of pharmacovigilance awareness and practice among healthcare professionals at the hospital level and offer recommendations to enhance ADR reporting and improve drug safety practices.

Methodology

Study design

This study was a descriptive cross-sectional, hospital-based study conducted over a two-month period from July to August 2024.

Study area

This study was conducted at Atbara Teaching Hospital, which is located in the city of Atbara in River Nile State, northeastern Sudan. Atbara, known as the railway city for its historical role in Sudan’s railway system, Lies along the River Nile, approximately 300 km northeast of Khartoum, the capital. The hospital is a major tertiary-level facility with approximately 250 beds, serving as both a referral center and a teaching hospital for medical students, interns, and residents. It was selected for this study due to its central role in regional healthcare delivery and medical education. Additionally, as part of Sudan’s national healthcare network, it operates within the system overseen by the National Pharmacovigilance Center,which is managed by the National Medicines and Poisons Board (NMPB) and covers the entire country.

Study population

The study population comprised healthcare professionals, including doctors, nurses, and pharmacists, working at Atbara Teaching Hospital. These professionals were selected because of their direct involvement in patient care and their potential role in reporting and managing ADRs. Hospital staff who were not involved in the process of drug prescription and delivery, such as radiologists and laboratory technicians, as well as healthcare professionals (doctors, nurses, and pharmacists) who refused to participate in the study were excluded.

Sample size

The study sample size was calculated via Yamane’s formula:

where:

n is the sample size.

N is the population size = 176.

e is the margin of error = 5% = 0.05.

Sample size (n) = 122.

The total population was 176 (95 doctors, 54 nurses, and 27 pharmacists).

Thus, the sample size was 122 (66 doctors, 38 nurses, and 18 pharmacists).

Sampling method

To minimize selection bias, a stratified simple random sampling method was carried out after a comprehensive List of all healthcare professionals, which included 176 healthcare professionals at the time, was obtained from the medical director of Atbara Teaching Hospital. The healthcare professionals were categorized into doctors, nurses, and pharmacists, and the number and percentages of each group were calculated to determine the total population. The sample size was subsequently calculated. On the basis of the calculated percentages, the appropriate number of doctors, nurses, and pharmacists was determined, ensuring proportional representation of each category. To collect responses, simple random sampling was performed by randomly selecting individuals from each profession from the list.

Data collection instrument

Data were collected via a structured, self-administered questionnaire distributed to healthcare professionals after verbal and written informed consent was obtained. Response bias was minimized by ensuring confidentiality, anonymity, and voluntary participation. The questionnaire was developed based on a comprehensive literature review on pharmacovigilance and adverse drug reaction reporting practices among healthcare professionals. The questionnaire was designed to assess four key domains: demographics and KAP related to Pharmacovigilance. Prior to data collection, informal interviews were conducted with a small group of healthcare professionals to identify relevant local barriers to ADR reporting. These insights helped shape the multiple-choice options for the barrier-related question The data collection tool included 4 sections. The demographics section gathered information on profession, gender, age, and years of practice. The knowledge section contained a total of 12 questions. Each had one best answer, and one point was given for each correct answer, yielding a total score range of 0–12. On the Basis of modified Bloom’s criteria adapted from previous pharmacovigilance KAP studies [14, 15], knowledge scores were categorized as poor (0–4), moderate (5–8), and good (9–12). Attitudes toward pharmacovigilance and adverse drug reaction (ADR) reporting were assessed via three structured items, each offering four response options. The responses were scored on a 4-point ordinal scale, with higher scores indicating a more favorable attitude. Specifically, favorable responses (e.g.,"Yes,""Should be in every hospital") were assigned a score of 3, mildly favorable responses (e.g.,"May be,""Depends on number of bed size in the hospitals") were scored as 2, uncertain responses (e.g.,"Can’t say,""One in a city is sufficient") were given a score of 1, and unfavorable responses (e.g.,"No,""Not necessary in every hospital") were given a score of 0. The total attitude score ranged from 0 to 9. Using the same modified Bloom’s cutoff, the attitude levels were categorized as negative (0–3), neutral (4–6), or positive (7–9). The practice section consisted of 5 questions assessing the participants’ practical engagement with pharmacovigilance and ADR reporting. Response options were Yes, No, May be, and Can’t say. To capture uncertainty, May be and Can’t say were included and treated as negative responses when classifying participants as reporters or non reporters, and as trainers or non trainers, for subsequent analysis. Additionally, the questionnaire included a question on reasons for ADR underreporting.

Pre-test and validation of the instrument

Content validity was assessed by academic experts in pharmacovigilance, who reviewed the questionnaire to ensure alignment with the study objectives, comprehensiveness, and clarity of the item statements. Subsequently, face validity was evaluated through a questionnaire pre-test involving 10 randomly selected healthcare professionals from the study setting. The purpose was to assess the questionnaire's clarity, acceptability, and ease of administration. All participants indicated that the items were clear and understandable, and no modifications were deemed necessary. The final version of the questionnaire was approved by the Department of Community Medicine, Faculty of Medicine, University of Khartoum.

Data management and analysis

The questionnaires were refined and managed carefully; the competency of the data was ensured by checking the completeness of the responses. There were no missing or incomplete answers from any participants, indicating a high level of data quality. Therefore, no responses were deleted. The collected data were analyzed via the Statistical Package for Social Science (SPSS) version No. 29. Descriptive statistics such as frequencies, percentages, and means (± standard deviations), were used to summarize the findings. Inferential statistics were applied to explore the associations between demographic factors and KAP levels via the Chi-square test of independence. A p-value less than 0.05 was considered statistically significant. For findings that showed a significant association, the Pearson Chi-square (x²) test was reported, and the strength of the association was further assessed via Cramer’s V.

Results

Demographic characteristics of healthcare professionals

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

Table 1.

Demographic characteristics of the healthcare professionals (n = 122)

	Frequency (%)
Healthcare profession
Doctors	66 (54.1%)
Nurses	38 (31.1%)
Pharmacists	18 (14.8%)
Gender
Male	30 (24.6%)
Female	92 (75.4%)
Age
(Less than 26)	48 (39.4%)
(26–30)	50 (41.0%)
(31–35)	10 (8.2%)
(36–40)	7 (5.7%)
(More than 40)	7 (5.7%)
Years of practice
(0–5)	96 (78.7%)
(6–10)	16 (13.1%)
(11–15)	6 (4.9%)
(16–20)	0 (0.0%)
(more than 20)	4 (3.3%)

Knowledge of healthcare professionals regrading pharmacovigilance

The overall mean knowledge score was 5.1 ± 1.9 out of 12. The doctors had a mean score of 5.1 ± 1.9, The nurses had a mean score of 4.7 ± 1.9, and the pharmacists had a mean score of 5.9 ± 1.9. The knowledge levels of each healthcare profession are presented in Fig. 1. Among the healthcare professionals surveyed, 67.2% correctly defined pharmacovigilance, and 69.7% were aware that its most important purpose is to ensure the safety and efficacy of the drug. Moreover, 54.1% correctly defined ADR, whereas only 9.8% knew that rare ADRs were identified during phase-4 clinical trials. A total of 63.9% of the healthcare professionals agreed that ADR reporting is a professional obligation for them, and 68% believed that all healthcare professionals (doctors, nurses, and pharmacists) are responsible for reporting ADRs. Only 23.8% were aware of the existence of a national pharmacovigilance program in Sudan, and 61.5% of the participants identified the national medicines and poisons board as the regulatory body responsible for monitoring ADRs in Sudan. Additionally, 19.7% knew that the International Center for ADR monitoring is located in Sweden. Only 27% knew that a serious ADR in Sudan was reported to the regulatory body within seven calender days, and 17.2% knew that a non serious adverse event was reported within thirty calender days. Furthermore, 27% of the participants were aware that spontaneous reporting system is the method commonly employed by healthcare professionals to monitor ADRs associated with new drugs once they are introduced in the market. The responses to the knowledge section are presented in Table 2.

Fig. 1.

Distribution of knowledge levels among healthcare professions (n = 122)

Table 2.

Distribution of knowledge-related responses from healthcare professionals (n = 122)

Knowledge question	Options	n (%)
- How would you define pharmacovigilance	(a) The process of developing new drugs	19 (15.6%)
	(b) The science of monitoring ADR in a hospital	15 (12.3%)
	(c) The study of pharmaceutical marketing strategies	6 (4.9%)
	(d) The detection, assessment, understanding and prevention of adverse events. (correct)	82 (67.2%)
- In your opinion the most important purpose of pharmacovigilance	(a) To ensure safety and efficacy of the drug. (correct)	85 (69.7%)
	(b) To calculate incidence of ADRs	13 (10.7%)
	(c) To identify predisposing factors to ADRs	17 (13.9%)
	(d) To identify previously unrecognized ADRs	7 (5.7%)
- How would you define adverse drug reaction(ADRs)	(a) A noxious unintended response occurs at normal doses. (correct)	66 (54.1%)
	(b) A noxious unintended response occurs at high doses	34 (27.9%)
	(c) A normal response occurs at low doses	18 (14.8%)
	(d) A normal response occurs at high doses	4 (3.3%)
-Rare ADRs can be identified in the following phase of clinical trial	(a) During phase-1 clinical trials	25 (20.5%)
	(b) During phase-2 clinical trials	26 (21.3%)
	(c) During phase-3 clinical trials	3 (2.5%)
	(d) During phase-4 clinical trials. (correct)	12 (9.8%)
	(e) I don’t know	56 (45.9%)
- Do you think ADR reporting is a professional obligation for you	(a) Yes. (correct)	78 (63.9%)
	(b) No	11 (9.0%)
	(c) Can’t say	8 (6.6%)
	(d) Maybe	25 (20.5%)
- The healthcare professional responsible for reporting ADR in a hospital is\are	(a) Doctors	15 (12.3%)
	(b) Nurses	6 (4.9%)
	(c) Pharmacists	18 (14.8%)
	(d) All of the above. (correct)	83 (68.0%)
- Do you think there is national pharmacovigilance programme in Sudan	(a) Yes. (correct)	29 (23.8%)
	(b) No	34 (27.9%)
	(c) Can’t say	18 (14.8%)
	(d) Maybe	41 (33.6%)
- In Sudan what is the regulatory body responsible for monitoring adverse drug reactions:	(a) National medicines and poisons board. (correct)	75 (61.5%)
	(b) Ministry of health	33 (27.0%)
	(c) Sudan medical council	12 (9.8%)
	(d) National health insurance and fund Sudan	2 (1.6%)
- Where the international center for adverse drug reaction monitoring is located	(a) United States of America	80 (65.6%)
	(b) United Kingdom	15 (12.3%)
	(c) France	3 (2.5%)
	(d) Sweden. (correct)	24 (19.7%)
- In your opinion a serious adverse event in Sudan should be reported to the regulatory body within:	(a) One day	36 (29.5%)
	(b) Seven calender days. (correct)	33 (27.0%)
	(c) Fourteen calender days	6 (4.9%)
	(d) Thirty calender days	12 (9.8%)
	(e) I don’t know	35 (28.7%)
- In your opinion a non serious adverse event in Sudan should be reported to the regulatory body within:	(a) One day	33 (27.0%)
	(b) Seven calender days	16 (13.1%)
	(c) Fourteen calender days	16 (13.1%)
	(d) Thirty calender days. (correct)	21 (17.2%)
	(e) I don’t know	36 (29.5%)
- Which of the following methods do you think is commonly employed by healthcare professional to monitor ADRs of new drugs ones they are launched in the market:	(a) Meta analysis	25 (20.5%)
	(b) Spontaneous reporting system. (correct)	33 (27.0%)
	(c) Population studies	25 (20.5%)
	(d) Regression analysis	2 (1.6%)
	(e) I don’t know	37 (30.3%)

ADR Adverse drug reaction

Attitude of healthcare professionals toward pharmacovigilance

The overall mean attitude score was 7.7 ± 2.0 out of 12, with doctors scoring 7.6 ± 1.8, nurses scoring 7.7 ± 2.2,and pharmacists scoring 7.9 ± 2.0. The attitude levels for each healthcare profession are presented in Fig. 2. A total of 95.1% of healthcare professionals stated that reporting of ADRs is necessary. Additionally, 79.5% agreed with the view that pharmacovigilance should be taught to all healthcare professionals, and 62.3% of the healthcare professionals agreed that an ADR monitoring center should be established in every hospital. The responses to attitude section are presented in Table 3.

Fig. 2.

Distribution of attitude levels among healthcare professions (n = 122) Practice of pharmacovigilance regarding healthcare professionals: Among healthcare professionals, 66.4% had observed adverse drug reactions in patients but only 18.9% reported these ADRs to the pharmacovigilance center

Table 3.

Distribution of attitude-related responses from healthcare professionals (n = 122)

Attitude question	Options	n (%)
-Do you think reporting of adverse drug reactions is necessary:	(a) Yes	116 (95.1%)
	(b) No	3 (2.5%)
	(c) Can’t say	0(0.0%)
	(d) Maybe	3 (2.5%)
-Do you think pharmacovigilance should be taught to all healthcare professionals:	(a) Yes	97 (79.5%)
	(b) No	10 (8.2%)
	(c) Can’t say	4 (3.3%)
	(d) Maybe	11 (9.0%)
-What is your opinion about establishing ADR monitoring center in every hospital:	(a) Should be in every hospital	76 (62.3%)
	(b) Not necessary in every hospital	15 (12.3%)
	(c) One in a city is sufficient	22 (18.0%)
	(d) Depend on number of bed size in the hospital	9(7.4%)

ADR Adverse drug reaction

Doctors observed 44 ADRs in practice, nurses observed 28 ADRs, and pharmacists observed 9 ADRs. In terms of ADR reporting, doctors submitted 9 reports, nurses reported 10, and pharmacists submitted 4 reports. In terms of the ratio of ADR reported to observed, it was found that doctors had 20.4% reporting ratio, nurses had 35.7% reporting ratio, and pharmacists had 44% reporting ratio. Additionally, only 26.2% had seen the ADR report form, 12.3% have participated in pharmacovigilance training or workshops, and 41% participants read an article on preventing of adverse drug reaction. The responses to the practice section are presented in Table 4.

Table 4.

Distribution of practice-related responses from healthcare professionals (n = 122)

Practice question	Option	n (%)
-Have you at any time read an article on preventing of adverse drug reactions:	(a) Yes	50 (41.0%)
	(b) No	45 (36.9%)
	(c) Can’t say	6 (4.9%)
	(d) Maybe	21 (17.2%)
-Have you ever experienced adverse drug reaction in your patient during your professional practice:	(a) Yes	81 (66.4%)
	(b) No	30 (24.6%)
	(c) Can’t say	6 (4.9%)
	(d) Maybe	5 (4.1%)
-Have you ever reported ADR to the pharmacovigilance:	(a) Yes	23 (18.9%)
	(b) No	93 (76.2%)
	(c) Can’t say	3 (2.5%)
	(d) Maybe	3 (2.5%)
-Have you ever seen the ADR reporting form:	(a) Yes	32 (26.2%)
	(b) No	84 (68.9%)
	(c) Can’t say	3 (2.5%)
	(d) Maybe	3 (2.5%)
-Have you ever participated in any pharmacovigilance training or workshops	(a) Yes	15 (12.3%)
	(b) No	101 (82.8%)
	(c) Can’t say	2 (1.6%)
	(d) Maybe	4 (3.3%)

ADR Adverse drug reaction

Barriers to adverse drug reaction reporting

The factors discouraging healthcare professionals from reporting ADRs were don’t know how/where to report ADRs with 39.4% reported answer, no reward/remuneration with 27.0%, lack of time to report ADRs with 18.0%, and not my responsibility with 7.4%. Noted that 8.2% of the respondents chose others in their answer, two of whom stated that they had difficulty in deciding whether the event is an adverse drug reaction or not. The reasons for underreporting are presented in Fig. 3.

Fig. 3.

Reasons for the underreporting of ADRs by healthcare professionals (n = 122)

Inferential statistics

Chi-square tests of independence were used to assess associations between healthcare profession, pharmacovigilance training, knowledge level, attitude, and ADR reporting. As shown in Table 5, there were no statistically significant associations between healthcare profession and knowledge level (p = 0.14), attitude level (p = 0.92), or ADR reporting (p = 0.26). In contrast, as presented in Table 6, a statistically significant association was observed between pharmacovigilance training and ADR reporting (p = 0.008, x² = 8.6, Cramer's V = 0.27), as well as between knowledge level and ADR reporting (p = 0.02, x² = 7.6, Cramer's V = 0.25), but no significant association was observed between attitude level and ADR reporting (p = 0.23). Furthermore, a significant association was found between knowledge level and attitude towards pharmacovigilance (p < 0.001, x² = 21.6, Cramer's V = 0.30), as shown in Table 7.

Table 5.

Associations between the healthcare profession and knowledge level, attitude level, and ADR reporting (n = 122)

		Level of knowledge				p-value
		Good	Moderate		Poor
Profession	Doctor	0	40		26	0.14
	Nurse	0	21		17
	Pharmacist	1	12		5
		Level of attitude
		Positive	Neutral		Negative
Profession	Doctor	50	8		8	0.92
	Nurse	29	5		4
	Pharmacist	14	3		1
		ADR reporting
		Reporters		Non reporters
Profession	Doctor	9		57		0.26
	Nurse	10		28
	Pharmacist	4		14

Table 6.

Associations between pharmacovigilance training, knowledge level, attitude level, and ADR reporting (n = 122)

		ADR reporting		p-value
		Reporters	Non reporters
Pharmacovig ilance training	Trainers	7	8	0.008
	Non trainers	16	91
Pearson Chi-square (x2) = 8.6 Cramer’s V = 0.27
Level of knowledge	Good	1	0	0.02
	Moderate	19	66
	Poor	3	33
Pearson Chi-square (x2) = 7.6 Cramer’s V = 0.25
Level of attitude	Positive	16	79	0.23
	Neutral	5	9
	Negative	2	11

Table 7.

Association between knowledge and attitude level toward pharmacovigilance (n = 122)

		Level of Attitude			p-value
		Positive	Neutral	Negative
Level of knowledge	Good	1	0	0	< 0.001
	Moderate	66	7	0
	Poor	33	7	8

Pearson Chi-square (x²) = 21.6 Cramer’s V = 0.30

Discussion

The current study assessed the knowledge, attitudes, and practices (KAPs) of pharmacovigilance, as well as the barriers responsible for underreporting among healthcare professionals, including doctors, nurses, and pharmacists, at Atbara Teaching Hospital in Atbara, Sudan. A self-administered method was used for data collection, which allows the researcher to have better control over the data collection method and its quality [16], with a response rate of 100%, reflecting the advantages of the method. Regarding the demographic characteristics of the participants, the study included 122 healthcare professionals, with 66 doctors (54.1%), 38 nurses (31.1%), and 18 pharmacists (14.8%). These proportions were designed to reflect the distribution of each profession within the hospital, thereby ensuring proportional representation of each profession. The majority of the participants were female (75.4%), Likely due to the higher enrollment of females in healthcare related high education compared to males in Sudan. Primarily, they were younger than 30 years old, and had up to five years of experience. This suggests that the study sample predominantly consists of recent graduates and early-career professionals, which may reflect the ongoing demand for healthcare services in Sudan, attracting the younger workforce. Assessing healthcare professionals’ knowledge revealed they have a moderate level of knowledge regarding pharmacovigilance, with an overall mean knowledge score of 5.1 ± 1.9 out of 12. For doctors, the mean score was 5.1 ± 1.9, nurses scored 4.7 ± 1.9, and pharmacists scored 5.9 ± 1.9, which indicates that pharmacists had better knowledge regarding pharmacovigilance than did the other two professions. This distinction may be attributed to the fact that the concept of pharmacovigilance is more closely related to the study of pharmacy than to medical and nursing education. Similar findings have been reported in a previous study conducted in South Africa [17], where pharmacists exhibited increased knowledge and engagement in pharmacovigilance activities due to their specialized training and education in drug safety and ADR reporting. Approximately 67.2% of the participants correctly defined pharmacovigilance, and 69.7% recognized the most important purpose of pharmacovigilance as ensuring the safety and efficacy of the drug. These findings align with those of a similar study conducted at a tertiary care hospital in Lahore, Pakistan [18]. While 54.1% of the respondents correctly defined adverse drug reactions (ADRs), only 9.8% knew that rare ADRs were identified during phase-4 clinical trials. This suggest a gap in understanding the broader context of pharmacovigilance, particularly the role of postmarketing surveillance in detecting less common adverse drug reactions. A majority of the respondents (63.9%) viewed ADR reporting as a professional obligation for them, which is consistent with findings from a systemic review [19], indicating good knowledge of their duties in pharmacovigilance and understanding that reporting ADRs is not just an option but a professional obligation for them. Additionally, 68.0% acknowledged that ADR reporting is a shared responsibility among all healthcare professionals, including doctors, nurses, and pharmacists. This finding highlights a positive perception of inter professional collaboration in pharmacovigilance and reflects an encouraging level of awareness regarding the collective role in ensuring drug safety. Responses from healthcare professionals regarding their awareness of the national pharmacovigilance program and its reporting protocols revealed some concerning insights. Only 23.8% of respondents were aware of the program’s existence in Sudan, similar to a study conducted in India [20], indicating that low overall awareness could compromise drug safety efforts. While 61.5% recognized the National Medicines and Poisons Board as the regulatory authority for monitoring adverse drug reactions (ADRs), knowledge of specific reporting protocols was Limited. Only 27% knew that serious ADRs should be reported within seven days, and only 17.2% were aware that non-serious ADRs must be reported within thirty days. Additionally, only 27% identified the spontaneous reporting system as the most commonly used method for ADR monitoring. These findings highlight critical deficiencies in both awareness of the national pharmacovigilance framework and understanding of reporting requirements, emphasizing the need for targeted educational interventions. In terms of attitudes toward pharmacovigilance, healthcare professionals generally exhibited positive attitudes, with an overall mean attitude score of 7.7 ± 2.0 out of 12. Pharmacists had the most positive attitudes, scoring 7.9 ± 2.0, followed by nurses (7.7 ± 2.2) and doctors (7.6 ± 1.8). Notably, almost all the participants (95.1%) agreed that reporting ADRs is necessary, which aligns with the findings of a study conducted in South-West Nigeria [21]. Additionally, 79.5% of the participants believed that pharmacovigilance should be taught to all healthcare professionals. This finding is consistent with findings from a previous study [22]. Many of the participants (62.3%) supported the idea of establishing an ADR center in every hospital, reflecting a strong recognition of the need for a structured system to monitor and manage drug safety within healthcare facilities.

Regarding the practice of healthcare professionals towards pharmacovigilance, there was a notable gap. There was a significant gap between the proportion of healthcare professionals who observed ADRs in patients (66.4%) and those who reported them (18.9%). Doctors had observed the most ADRs in their patients, with 44 ADRs, more than nurses did, who observed 28 ADRs, and pharmacists who observed 9 ADRs. Regarding reporting of ADRs, nurses reported the most ADRs, with 10 reports, followed by doctors, with 9 reports and pharmacists, with 4 reports. However, in terms of the ratio of ADRs reported to observed, pharmacists had the best ratio, with 44.4% (4 reported out of 9 experienced), followed by nurses, with 35.7% (10 reported out of 28 experienced), and doctors, with 20.4% (9 reported out of 44 experienced). This imbalance between the number of ADRs observed and the number of ADRs reported among healthcare professionals has also been reported in many countries [23, 24], and it is typically associated with inadequate training in ADR reporting [25]. Training in ADR reporting has been shown to improve healthcare professionals’ knowledge and practice of ADR reporting [26], but only 15 respondents (12.3%) from this study had pharmacovigilance training. The study also identifies several barriers for underreporting. These barriers included uncertainty regarding how or where to report an ADR (39.4%), which aligns with several studies [27, 28]. This suggests that efforts to address the barriers to ADR reporting should focus on raising awareness about reporting procedures for ADRs by conducting training sessions and workshops. Other barriers identified were the absence of rewards or remuneration (27.0%), which was also reported in recent studies in Pakistan and China [29, 30]; the lack of time to report ADRs (18.0%), which was a major determinant in one study [31]; and the belief among some healthcare professionals that reporting ADRs was not their responsibility (7.4%). Notably, 10 participants (8.2%) mentioned others in their answers, two of whom stated that they had difficulty in deciding whether the event was an adverse drug reaction or not, further complicating the reporting process. A systemic review and meta-analysis study [32], indicated that imposing legal obligations for ADR reporting has been shown to increase both the frequency and accuracy of reporting. This finding implies that the absence of such legal obligations in Sudan may contribute to the underreporting of ADRs. To address this issue, it is recommended that legal requirements for ADR reporting be implemented in Sudan to overcome this barrier, which currently hinders effective reporting.

This study revealed a statistically significant association between pharmacovigilance training and ADR reporting (x² = 8.6, p = 0.008, Cramer's V = 0.27), indicating a moderate effect size. Healthcare professionals who had received formal pharmacovigilance training were more likely to report adverse drug reactions. This finding is consistent with previous research conducted at a tertiary teaching hospital in Jordan [33], which underscored the critical role of targeted training programs in enhancing pharmacovigilance reporting behaviors and improving patient safety outcomes. Furthermore, a significant association was observed between knowledge level and ADR reporting (x² = 7.6, p = 0.02, Cramer's V = 0.25), suggesting that healthcare professionals with higher levels of pharmacovigilance knowledge are more likely to engage in ADR reporting. This result supports findings from a study conducted in Turkey [34], which demonstrated that knowledge is a key determinant of reporting behavior. These results collectively highlight the importance of knowledge-based interventions in strengthening pharmacovigilance practices. The analysis also revealed a statistically significant association between knowledge and attitude level toward pharmacovigilance (x² = 21.6, p < 0.001, Cramer’s V = 0.30), reflecting a moderate relationship. Participants with higher knowledge levels were more likely to exhibit a positive attitude toward pharmacovigilance. This observation is also observed in a study in India [35], suggesting that improving knowledge may concurrently foster more favorable attitudes, thereby contributing to long-term improvements in pharmacovigilance practices.

Strengths and limitations of the study

This research is possibly the first of its kind conducted on healthcare professionals in Sudan, addressing a significant gap in the literature, which focused previously on pharmacists only. The study provides valuable insights into the knowledge, attitudes, and practices (KAPs) of pharmacovigilance among healthcare professionals at Atbara Teaching Hospital, with notable strengths such as a 100% response rate, a proportional representation of healthcare professions, and findings that highlight the importance of education and training in improving ADR reporting. The study’s identification of barriers to ADR reporting and its contribution to understanding pharmacovigilance in the Sudanese context further strengthen its relevance. However, this study has several limitations. Its single-center design and relatively small sample size limit the generalizability of the findings. Owing to the small sample size, multivariate analysis could not be performed, which restricted the ability to control for potential confounding factors. Additionally, the use of a self-administered questionnaire may introduce self-reporting bias, and the cross-sectional design prevents the establishment of causal relationships. Despite these limitations, this study establishes strong foundations for further research and the development of targeted strategies to enhance pharmacovigilance practices in Sudan.

Recommendations

The findings of this study highlight the urgent need for targeted and context- appropriate interventions to improve pharmacovigilance (PV) practices and adverse drug reaction (ADR) reporting among healthcare professionals at Atbara Teaching Hospital. Regular and structured in-service training and workshops should be institutionalized to increase healthcare professionals’ knowledge and practical skills in PV and ADR reporting, addressing the lack of formal training reported by participants. Raising awareness about the reporting process and providing accessible tools such as standardized ADR forms or digital reporting options can significantly reduce underreporting. The integration of electronic reporting systems into hospital workflows, where feasible, and the establishment of hospital-level PV focal points can further strengthen the reporting infrastructure. Motivational strategies, including nonfinancial incentives such as recognition awards or continuing professional development (CPD) credits for active reporters, are low cost and feasible in the Sudanese context. The incorporating of pharmacovigilance education into undergraduate medical, nursing, and pharmacy curricula promotes early awareness and competence, while community awareness campaigns can engage the public and encourage patient involvement in ADR reporting. Policymakers should also consider introducing mandatory reporting regulations accompanied by legal protection to create a safe and transparent reporting environment. Given the limitations of this study, such as its single-center design and small sample size, further large-scale, multicenter research is recommended to explore PV practices more comprehensively across Sudan. Among these recommendations, initiating regular training sessions within existing institutional frameworks stands out as the most practical and immediately feasible step in the Sudanese healthcare context.

Conclusion

This study highlights a critical gap between healthcare professionals'awareness of pharmacovigilance and their practice of ADR reporting. While participants demonstrated moderate knowledge and positive attitudes, low reporting rates persisted, primarily due to unfamiliarity with reporting procedures. The significant association between pharmacovigilance training and ADR reporting underscores the need for standardized education programs across all healthcare disciplines. Importantly, the consensus on the necessity of ADR reporting and curricular integration of pharmacovigilance suggests a receptive environment for systemic interventions. Future efforts should prioritize institutional training initiatives and streamlined reporting mechanisms to bridge this gap.

Abbreviations

PV

Pharmacovigilance

WHO

World Health Organization

ADRs

Adverse drug reactions

NMPB

National Medicine and Poisons Board

MRA

Medicine Regulatory Authority

PVC

Pharmacovigilance Center

UMC

Uppsala Monitoring Center

KAP

Knowledge, attitude, and practice

SPSS

Statistical package for social sciences

Authors’ contribution

First author M.H., prepared the questionnaire, collected the data, analyzed and interpreted them, and wrote the final manuscript. Second author M.O., supervised the whole process of the research, was a major contributor to the formulation of the questionnaire, interpretation of the data, and writing of the final manuscript. Both authors wrote and approved the final manuscript.

Funding

There was no source of funding for the research.

Data availability

The data used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

The study was reviewed and approved by the Institution Review Board (IRB) of the Department of Community Medicine, Faculty of Medicine, University of Khartoum (ID number: COMMED 2024–95-34). Permission was obtained from the medical director of Atbara Teaching Hospital to conduct the research. Informed verbal and written consent was obtained from each participant. As the study involved human participants, it was conducted in accordance with the principles of the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interest

The authors declare no competing interests.