Knowledge, Attitude, Practice, and Barriers Toward Pharmacovigilance Among Pharmaceutical Sales and Marketing Personnel in Saudi Arabia: A Cross-Sectional Study

TL;DR

This study assesses the knowledge, attitude, and practices of Saudi pharmaceutical sales and marketing personnel regarding drug safety and identifies factors affecting their performance.

Contribution

The first study to evaluate pharmacovigilance KAP and barriers among Saudi pharmaceutical sales and marketing personnel.

Findings

57% of participants had good knowledge of pharmacovigilance.

Non-pharmacy degrees and local employment were linked to poorer knowledge and practice.

92.8% perceived a non-challenging work environment for pharmacovigilance.

Abstract

Sales and marketing personnel are among the most knowledgeable individuals regarding the safety of the medications they promote. No previous work has assessed pharmaceutical sales and marketing personnel’s knowledge, attitude, practice (KAP), and barriers toward pharmacovigilance (PV) in Saudi Arabia; therefore, the present study aimed to assess these aspects and to scrutinize their associations with the subjects’ baseline characteristics. A validated questionnaire comprising five sections (baseline characteristics, knowledge, attitude, practice, and barriers) was disseminated via email networks and social media platforms between 18 March and 31 May 2025. All employees working in the sales and marketing departments of pharmaceutical companies in Saudi Arabia were eligible to participate. Participants’ responses were categorized as good or poor knowledge, positive or negative attitude, good or poor practice, and challenging or non-challenging work environment, based on the cumulative score in each respective section, using a 60% cutoff. A total of 400 participants completed the survey. Of these, about one-third (37.3%) had 2–4 years of professional experience and two-thirds (63%) were employed by multinational companies. Overall, 57% and 83.5% had good knowledge and positive attitude, respectively. The work environment was considered non-challenging by 92.8% of participants, and 61% reported good practice. We noted that holding a non-pharmacy degree was a significant predictor of poor knowledge and a challenging work environment. Additionally, employment in a local company was significantly associated with poor knowledge and practice. Pharmaceutical sales and marketing personnel in Saudi Arabia demonstrated acceptable levels of KAP and reported few barriers toward PV, with an opportunity for improvement.

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1. Introduction

Pharmacovigilance (PV) is defined by the WHO as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem [1].” Adverse effects and drug-related problems impose a significant burden on the healthcare system by increasing the risk of patient injury, high healthcare costs, hospitalization, prolonged length of hospital stays, readmission, morbidity, and mortality [2,3,4,5,6,7,8,9]. In Saudi Arabia, pharmaceutical sales and marketing personnel are legally required to be licensed pharmacists. They receive intensive product-specific training, which makes them well-informed about the medications they promote. Therefore, their knowledge, attitude, practice (KAP), and barriers toward PV are of paramount importance.

According to the Saudi Food and Drug Authority (SFDA) guideline on Good Pharmacovigilance Practices (GVP), all staff who interact with healthcare professionals (HCPs) are part of the PV system, including sales and marketing employees [10]. Marketing authorization holders (MAHs) are responsible for ensuring that an appropriate infrastructure that supports good PV practices is in place, including a well-structured PV system, adequate training, as well as a blame-free culture [10]. MAHs must have a full-time qualified person responsible for pharmacovigilance (QPPV) who resides in Saudi Arabia, who is expected to create the local standard operating procedures (SOPs) for handling PV activities, e.g., handling of local individual case safety reports (ICSRs), preparing and updating pharmacovigilance system master file (PSMF) and pharmacovigilance sub-system file (PSSF), as well as preparing and submitting periodic safety update report/periodic benefit-risk evaluation report (PSUR/PBRER) [10]. QPPV should facilitate employees’ compliance with the PV system by ensuring easy access to PV tools like forms and contacts as well as by monitoring reporting compliance via key-performance indicators (KPIs) and field audits [10].

Most existing literature focuses on KAP toward PV among HCPs in settings like hospitals and community pharmacies. For instance, Abdulsalim and colleagues surveyed 209 community pharmacists in Qassim, Saudi Arabia, and reported good knowledge and a highly positive attitude; however, the majority of respondents (85.6%) did not know how to report adverse drug reactions (ADRs) [11]. Similarly, another cross-sectional study by Jose et al. in Oman included 107 community pharmacists and reported a lack of awareness on how to report ADRs among the top discouraging factors among participants [12]. Additionally, 377 hospital and community pharmacists in Texas, the US, were surveyed and 70% reported not having ever reported an ADR [13].

Pharmaceutical sales and marketing personnel’s KAP and barriers toward PV remain unassessed either locally or globally. Hence, the primary objective of this study was to assess pharmaceutical sales and marketing personnel’s KAP and barriers toward PV in Saudi Arabia and to scrutinize their associations with the subjects’ baseline characteristics.

2. Materials and Methods

2.1. Study Design and Participants

This study employed a cross-sectional design and utilized a self-administered online survey, which was developed based on an extensive review of the literature on PV KAP studies, with adaptation to the local context of pharmaceutical sales and marketing personnel. It was further refined in the validation process to ensure clarity and relevance. It was validated for its structure, face, and content, and tested through a pilot study. Validation was conducted by a panel of five experts, including three PV specialists and two academic researchers with expertise in survey methodology. The pilot sample comprised 25 pharmaceutical sales and marketing personnel in Saudi Arabia. Feedback indicated no difficulties, and thus no changes were required beyond the initial modifications recommended by the validation panel. The questionnaire was hosted on Google Forms and disseminated through email networks as well as social media platforms [i.e., LinkedIn (version 9.31.5267), X (version 11.25.1), and WhatsApp (version 2.25.26.72)] to maximize reach among pharmaceutical sales and marketing personnel across Saudi Arabia between 18 March and 31 May 2025. The present cross-sectional study aligns with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines to ensure methodological robustness.

2.2. Sample Size and Sampling Technique

The present study employed a convenience sampling approach, and all employees working in the sales and marketing departments of pharmaceutical companies in Saudi Arabia were eligible to participate. Using the Raosoft sample size calculator, we factored in a population size of 20,000 (as official figures for pharmaceutical sales and marketing personnel are not available), a 95% confidence level, 5% margin of error, and an expected response rate of 50%. A minimum sample size of 377 was calculated [14].

2.3. Survey Design

The questionnaire was divided into five main sections designed to collect data on demographics and work-related characteristics, knowledge, attitude, practice, and barriers toward PV. The measurement of the four aspects toward PV was conducted using nine items for knowledge, four items for attitude, eight items for practice, and 18 items for barriers. Participants’ responses were categorized as good or poor knowledge, positive or negative attitude, good or poor practice, and challenging or non-challenging work environment, based on the cumulative score in each respective section, using a 60% cutoff [15]. For instance, those who answered six items or more correctly in the knowledge section were considered to have good knowledge, and those who identified 11 items or more in the barriers section as factors hindering them from being compliant to the PV system were considered to have a challenging work environment. The questionnaire was pretested on a pilot sample to ensure clarity and is available in the Supplementary File S1. Participants were required to answer all questions prior to submitting the questionnaire in order to ensure complete responses and avoid missing data.

2.4. Statistical Analysis

Data were analyzed using SPSS Statistics, version 26. Descriptive and inferential statistical analyses were performed. Associations between dependent variables, i.e., KAP and barriers and independent variables, i.e., current position (sales vs. marketing department), region (central vs. non-central), academic qualification (pharmacy vs. non-pharmacy degree), years of experience (<4 vs. ≥4), type of company (local vs. multinational), and frequency of interaction with HCPs (daily vs. non-daily) were examined using the chi-square test and the equivalent Fisher’s exact test. These independent variables were selected after discussions among the authors, primarily because they were expected to provide useful insights for decision makers aiming to target specific subgroups with the necessary interventions.

2.5. Ethical Considerations

The study protocol was reviewed and approved by the Committee of Research Ethics at Qassim University (No. 25-30-11). Participation was voluntary, and respondents were permitted to withdraw at any time without providing a reason. Anonymity and confidentiality were maintained, with no identifying information collected.

3. Results

3.1. Baseline Characteristics

A total of 400 participants completed the survey. Of these, the majority (94.3%) and (92.5%) were working in a sales department and aged between 25 and 34, respectively. About one-third (37.3%) had 2–4 years of professional experience and two-thirds (63%) were employed by multinational companies. Most of the respondents (97.8%) and (86%) hold a degree in pharmacy and were interacting with HCPs on a daily or almost daily basis, respectively. Table 1 summarizes the participants’ baseline characteristics.

3.2. Knowledge

Overall, 57% of respondents demonstrated good knowledge. However, over half (56%) were unable to identify the correct definition of PV, and almost half (51.2%) did not know the primary purpose of PV activities. Table 2 illustrates the respondents’ answers to the knowledge section.

3.3. Attitude

Although only 51.8% of participants deemed the ADRs reporting form not complex to fill out, the majority of respondents (83.5%) manifested a positive attitude. Further details regarding attitude are highlighted in Table 3.

3.4. Practice

Overall, 61% of participants reported good practice. Notably, more than one-third of respondents (39.8%) reported not having ever reported an ADR, and more than half (59.3%) reported not having reported an ADR in the last 12 months. One-third (33.2%) indicated that they do not report the ADR within one business day, with about one-fifth (19%) having no specific time frame. Table 4 highlights the participants’ answers to the practice section.

3.5. Barriers

Although 92.8% of respondents reported having non-challenging work environments, nearly half (44.8%) and (47%) felt they lack sufficient time to complete ADR reports and were not aware of the national ADR reporting system and how to use it, respectively. Additionally, over one-third (38%) expressed concern that reporting ADRs could negatively impact their career progression or job security. The most commonly perceived barriers to ADR reporting are illustrated in Figure 1, and further details regarding barriers are highlighted in Table 5.

3.6. Associations Between Demographic Characteristics and PV Aspects

The distribution of knowledge, attitude, practice, and work environment (assessed through perceived barriers) among study participants is illustrated in Figure 2, and the associations between the subjects’ baseline characteristics and PV-related aspects are presented in Table 6 and Figure 3. Poor knowledge was significantly associated with employment in marketing departments, residence in non-central regions, holding a non-pharmacy degree, working for local companies, and not interacting with HCPs on a daily basis. Poor practice was significantly linked to having fewer than four years of professional experience and working for local companies. Having a challenging work environment was significantly associated with holding a non-pharmacy degree.

4. Discussion

To the best of our knowledge, this is the first study that has evaluated KAP and barriers toward PV among pharmaceutical sales and marketing personnel. Our findings demonstrate that 57% and 83.5% of respondents in Saudi Arabia had good knowledge and positive attitude, respectively. The work environment was considered non-challenging by 92.8% of participants, and 61% reported good practice. We noted that holding a non-pharmacy degree was a significant predictor of poor knowledge and a challenging work environment, and working for local companies was significantly associated with poor knowledge and practice. Additionally, employment in marketing departments, residence in non-central regions, and not interacting with HCPs on a daily basis were significantly linked to poor knowledge, and having fewer than four years of professional experience was significantly linked to poor practice.

In the assessment of knowledge, the study findings were consistent with those reported by Abdulsalim et al. who reported good knowledge among pharmacists, who represent the majority of this study participants (97.8%) [11]. However, in both studies a considerable proportion of respondents were unable to identify the correct definition of PV and did not know the primary purpose of PV activities. This gap was more pronounced in our study, which could be attributed to differences in target sample sizes between the two studies and could be mitigated by encouraging QPPVs to better highlight their role by providing adequate training as mandated by the SFDA [10]. The association between poor knowledge and holding a non-pharmacy degree noted in our study supports the decision of limiting both sales and marketing roles to pharmacists. Additionally, the association between poor knowledge and employment in a local company could be attributed to comparatively limited pharmacovigilance infrastructure and fewer structured training opportunities. Lastly, given the association between working in non-central regions and poor knowledge, more intensive training for personnel in these regions is suggested.

Most of the existing literature supports the positive attitude toward PV observed in our study [11,16,17]. This trend is reflected globally as well as nearly all respondents (97%) in an Australian study conducted by Li and colleagues who surveyed 232 community pharmacists believed that ADR reporting is important and 93% felt that they are obliged to report ADRs [18]. In our study, only 51.8% of participants deemed the ADR reporting form not complex to fill out. While this may not accurately reflect the overall perception since 16% were unsure, likely due to a lack of prior experience with the form, this remains concerning. It can be tackled by urging QPPVs to offer personalized training to those who find the form complex. The training should emphasize what actually needs to be reported for a valid ADR report: a single patient information (initials, sex, weight, age or date of birth), suspected medicine, suspected adverse reaction, and an identifiable reporter (name, initials, address, contact information, or qualification) [19].

Despite that 61% of participants in our study were found to demonstrate good practice, more than one-third of respondents (39.8%) reported not having ever reported an ADR, and more than half (59.3%) reported not having reported an ADR in the last 12 months. These findings were substantiated by other studies. For example, 77% of community pharmacists and 73.2% of hospital pharmacists reported not having ever reported an ADR in Saudi Arabia and Kuwait, respectively [11,16]. This also mirrors the situation in the US, where 51% of HCPs reported not having submitted an ADR in the past five years [20]. Several strategies may help address this issue. For instance, enhanced awareness is needed to emphasize that even common and non-severe ADRs should be reported. This is imperative as a systematic review of 45 studies identified the belief that only severe ADRs need to be reported as the leading factor contributing to under-reporting [21]. Also, MAHs are encouraged to streamline the process by adopting PV systems that make ADR reporting straightforward. This is particularly important as a systematic review and meta-analysis identified integrating an electronic reporting manager as the most effective method to enhance ADR reporting and resulted in increasing reporting rate by more than five times [22]. Additionally, the association between good practice and multinational companies we observed in our study may possibly reflect the superior PV systems multinational companies utilize. Lastly, it is recommended that QPPVs exercise stricter oversight of sales and marketing personnel’s adherence to reporting practices as enhanced compliance is anticipated to positively influence overall reporting quality, and institutions are encouraged to acknowledge and recognize individuals with strong reporting records to foster a culture of proactive PV.

Regarding barriers, while most of the respondents in our study reported having non-challenging work environments (92.8%), a significant proportion indicated key obstacles to ADR reporting. Nearly half (44.8%) and (47%) felt they lack sufficient time to complete ADR reports and were not aware of the national ADR reporting system and how to use it, respectively. These findings were supported by other studies. For instance, Abdulsalim and colleagues reported that 41% felt they lack both the time and knowledge required for ADR reporting [11]. Additionally, Alsaleh et al. identified lack of knowledge as the most common barrier hindering pharmacists from ADR reporting in Kuwait (68.9%) [17]. These gaps can be addressed by targeted educational interventions. Also, MAHs are encouraged to reduce the workload of sales and marketing personnel to allow time for ADR reporting to be incorporated into their schedules. Another notable barrier is fear of professional repercussions. In our study, over one-third (38%) expressed concern that reporting ADRs could negatively impact their career progression or job security. Similarly, 69.3% of pharmacists in Najran, Saudi Arabia expressed concern regarding legal liability. These findings are alarming and warrant diligent attention by decision makers, including the SFDA. Given the high level of trust HCPs place in the SFDA, direct communication and reassurance from their end are anticipated to be impactful and influential in addressing this issue. Lastly, the highly positive attitude observed in our study did not translate into reporting practices. This suggests that barriers, particularly lack of awareness of the national ADR system, time constraints, and concerns regarding career progression or job security, play a critical role.

The National Pharmacovigilance Center (NPC) at the SFDA conducts regular inspections of the MAHs to assess their compliance with the PV-related regulations and guidelines. They select MAHs for inspection based on a risk-based methodology, which factors in various variables, including but not limited to the complexity of the organization and its PV system, the MAH reporting rate, its compliance and inspection history, as well as whether they have newly marketed products. Between 1 January 2025 and 30 June 2025, the NPC conducted 21 inspections and observed 87 findings classified as follows: seven critical, 55 major, and 25 minor findings. The critical findings were related to QPPV (n = 2), PSMF (n = 2), written instructions like SOPs and manuals (n = 1), management and reporting of adverse reactions (n = 1), and archiving (n = 1). Overall, considering the three categories, most of the findings were related to QPPV (n = 18), followed by PSMF (n = 15) and management and reporting of adverse reactions (n = 12). This trend has persisted throughout the past several years, with QPPV, PSMF, and management and reporting of adverse reactions being on the top of the findings list [23,24,25]. Given that these are integral parts of the QPPVs’ responsibilities, this highlights the significant role QPPVs play in this realm. Furthermore, it implies that MAHs should continue to work on fostering supportive environments that promote QPPVs’ continuous professional development as well as collaboration of other personnel with them.

The present study has some limitations. First, owing to that this is a self-administered, cross-sectional, survey-based study, our findings might have been impacted by a social desirability bias (i.e., the tendency of respondents to answer socially acceptable answers rather than those that reflect their true feelings and practices); hence, this limits the generalizability [26]. Second, given that there are no publicly available statistics regarding the number of pharmaceutical sales and marketing personnel in Saudi Arabia, we factored in a population size of 20,000 for the sample size calculation as suggested by the Roasoft calculator [14]. This population size seems reasonable based on internal industry estimates. Additionally, our use of email networks and various social media platforms to maximize reach among pharmaceutical sales and marketing personnel in Saudi Arabia. Moreover, our sample encompassed participants from diverse regions, companies (multinational and local), as well as experience levels, which have likely minimized the negative impact of this assumption on the reliability of our findings. Nonetheless, the lack of a precise population size may still limit the generalizability of our conclusions. Third, while multivariable regression analyses reflect the associations between the PV aspects and the subjects’ baseline characteristics more precisely, our study was only powered to use bivariate models. Four, only 2.3% of our participants had no pharmacy background, limiting the generalizability of our findings to this population in other countries, where pharmaceutical sales and marketing roles are not restricted to pharmacists. Lastly, internet penetration is nearly universal in Saudi Arabia (99%) and mobile access is almost ubiquitous [27]. Additionally, pharmaceutical companies in Saudi Arabia rely extensively on digital technologies and online communication platforms such as Teams, WhatsApp, and email groups to coordinate with their sales and marketing personnel, as well as our utilization of various online platforms likely have mitigated the risk of selection bias. Nevertheless, given that we relied on online dissemination of the questionnaire, the potential for selection bias cannot be entirely excluded.

5. Conclusions

Adverse effects and drug-related problems impose a significant burden on the healthcare system, and pharmaceutical sales and marketing personnel are among the most knowledgeable individuals regarding the medications they promote. Pharmaceutical sales and marketing personnel in Saudi Arabia demonstrated acceptable levels of KAP and reported few barriers toward PV, with an opportunity for improvement. This is further emphasized regarding their knowledge, particularly among those who hold a non-pharmacy degree and those who work in a local company, as well as their practice, particularly among those who have fewer than four years of professional experience and those who work in a local company. Strategies to address these deficiencies include: QPPVs are encouraged to provide personalized training and targeted educational interventions for personnel as mandated by the SFDA, MAHs are also encouraged to foster supportive environments that promote QPPVs’ continuous professional development as well as collaboration of other personnel with them, and the SFDA are suggested to reassure HCPs that reporting ADRs neither jeopardizes job security nor incurs legal liability.