Knowledge, Attitude, and Practice Regarding Pharmacovigilance and Barriers to Reporting Adverse Drug Reactions Among the General Population in Saudi Arabia

Introduction

Pharmacovigilance is widely acknowledged as an important component of the healthcare system.¹ According to the World Health Organization, pharmacovigilance is

the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other potential drug-related problems.

¹ Maintaining patient safety, which is critical in healthcare systems, is one of the key goals of pharmacovigilance.² While pharmacovigilance is a well-established concept in many countries, it is still relatively new in Saudi Arabia.³ However, it is clear that in many countries, the general public has only a minimal understanding of adverse drug reactions (ADRs) and pharmacovigilance.^4,5 When it comes to the importance of ADRs, they have a significant impact not only on clinical results but also on the economic burden on the healthcare system; the cost of ADRs in the United States (US) might be as high as $30.1 billion per year.⁶ According to a study conducted in the United Kingdom (UK), patients are not receiving adequate information regarding ADRs associated with their prescriptions.⁷ In Saudi Arabia, ADRs are the most common drug-related problem reported in the emergency department.⁸ According to a previous meta-analysis, the rate of ADRs in primary care settings was 8.32%, with nearly 22% of them being preventable.⁹ 3.5% of hospital admissions in Europe could be attributed to ADRs.¹⁰ It is also typical for people not to notify their physician or pharmacist when they experience an ADR.^11,12 About 15% of patients will stop taking their medications due to ADRs without informing their physician, indicating that they lack the knowledge or awareness to recognize ADRs. As a result, patients should be provided with the skills and knowledge to recognize and report ADRs.¹³ This includes information on the drug’s adverse reactions as well as what to do if they occur.¹³ In Saudi Arabia, more information about the population’s actual knowledge, attitude, and practice regarding pharmacovigilance is lacking.^14,15 Also, ADRs reporting barriers have not been addressed until now. However, when compared to studies conducted outside of Saudi Arabia, there is a dearth of studies on the general public’s understanding of PV and ADRs.¹⁶ Surveillance is necessary for identifying uncommon and underreported ADRs, as well as for improving clinical outcomes and lowering mortality rates.⁶ As important as it is, ADRs are considered a priority for recently approved drugs as uncommon ADRs are not always discovered in pre-marketing surveillance.¹⁷ The ADRs reporting system in the United States is divided into two parts: voluntary reporting for patients and medical practitioners and mandatory reporting for pharmaceutical companies.¹⁸ The yellow card system in the UK is based on non-mandatory reporting by health workers (physicians, pharmacists, nurses, and midwives) and patients.¹⁹ Patients play a vital role in pharmacovigilance systems and should be involved in all areas of them.²⁰ According to available literature,^21–23 there is a significant underreporting of ADRs among medical personnel, pharmaceutical manufacturers, and pharmaceutical trading companies in Saudi Arabia. As a result, expanding the spectrum of probable ADRs reported directly by patients can help improve reporting and assist in the early detection of critical ADRs signals.⁵ Patients are frequently aware of their health condition and prescribed treatment options.²⁴ As a result, they are quite well placed to engage in the reporting of ADRs and improve treatment safety.²⁴ In the Netherlands, they considered ADRs reported by patients to be valued equally with the ones reported by healthcare professionals.²⁰ In Saudi Arabia, the National Pharmacovigilance and Drug Safety Center (NPC) has made it possible for the wider public to report ADRs in a variety of ways, including Internet, faxing, and calls.²⁵ A variation within the provinces of Saudi Arabia has also been noticed in understanding ADRs, ADRs prevalence, reporting rate, and reporting barriers.¹⁶ Possible reasons for underreporting are the difficulty of the reporting process and the lack of realization of ADRs reporting importance.^26,27 The purpose of this study is to assess the knowledge, attitudes, and practices (KAP) of the general public in Saudi Arabia regarding pharmacovigilance, as well as to identify the barriers to reporting adverse drug reactions (ADRs). Pharmacovigilance is a critical component of ensuring drug safety, yet there is limited data on how well the public understands and engages with these practices. By evaluating the general population’s awareness and behavior in relation to pharmacovigilance, this study aims to highlight potential gaps in knowledge and practices, which can inform future public health initiatives. The primary objective is to assess the current state of knowledge, attitude, and practice regarding pharmacovigilance and to explore the factors that hinder the reporting of ADRs, offering insights that may guide improvements in public education and reporting systems in Saudi Arabia.

Methods

Study Setting

A cross-sectional design was chosen as it enables the collection of data at a single point in time to assess knowledge, attitudes, and practices (KAP) regarding pharmacovigilance across different demographics using an electronic survey (Google Forms) distributed through different social media platforms targeting the adult population living in Saudi Arabia. The study aims to collect responses on the online data collection tool, where the obtained data will be processed, analyzed, and presented to fulfill the study objectives.

Study Subjects

Participants were recruited through various social media platforms using convenience sampling. The inclusion criteria were adults aged 18 and older residing in Saudi Arabia. Participants who could not provide consent were excluded.The sample consisted of adults aged 18 years or more. The sample was not limited to any specific gender.

Sample Size

The sample size was calculated using the following formula:

The minimum sample size for this study was decided according to the formula:

n= Z² X P X Q

D²

Where n: calculated sample size, Z: The z-value for the selected level of confidence = 1.96, P: The assumed proportion of the general population with satisfactory knowledge, attitude, and practice on pharmacovigilance and barriers to the reporting ADRs = 50% = 0.5, Q: (1 – P) = 0.5, and D: The maximum acceptable error [precision level] = 0.05. The estimated sample size was at least 384 individuals.

Sampling Technique

The data collection tool was distributed online, targeting the Saudi population using an initial eligibility screening checklist to ensure that every participant is eligible for participation in compliance with the aforementioned study selection criteria. Distribution of the data collection tool stopped on reaching up to 20% more than the estimated sample size in order to cover for missing data and invalid inputs.

Data Collection methods, Instruments Used, Measurements

The survey instrument was refined from prior studies to meet the study’s aims.^4,5,27 The questionnaire was translated from English to Arabic by a language expert. The focus of the translation was not solely on the literal translation but also the conceptual meaning of the contents. The questionnaire was evaluated, validated, and pilot tested for clarity and content validity in various populations, along with faculty professionals. The validation process of our survey instrument was conducted in a systematic manner to ensure both clarity and relevance. This involved multiple stages, including pilot testing and thorough validity assessments aimed at refining the survey content. Reliability testing was an integral part of the process, confirming the internal consistency of the instrument. Feedback gathered from 10 participants during the pilot phase played a pivotal role in enhancing the design and structure of the questionnaire. To ensure broad accessibility and inclusivity, the final survey was made available in both Arabic and English. The survey included five parts: 1. socio-demographic characteristics, 2. participants’ knowledge of pharmacovigilance, 3. participants’ practices towards pharmacovigilance, 4. participants’ attitude towards pharmacovigilance, and 5. ADRs reporting barriers.

Data Management and Analysis Plan

Descriptive statistics, including frequency and percentage, were used to summarize the data. Scores for knowledge, attitude, and practice were calculated as for each question, every correct response counted for a score of 1, and incorrect responses counted for a 0. A sum of all items in each domain was obtained, where the minimum score was 0, and the maximum was 7, then the total score for the respondents in the knowledge and attitude domains was converted into a percentage score; in the knowledge domain, a total correct score > 80% was assigned as “adequate” general knowledge of PV and ADRs. In the attitude domain, a total ranked score > 80% signified a “positive” attitude towards PV and ADRs, while a total ranked score ≤ 80% was classified as a “negative” attitude. The cut-off for the overall percentage score in the knowledge and attitude domains was adapted from related studies.^4,5 Data analysis was conducted using Statistical Package for Social Software (SPSS) version 65. The determinant factors for the scores were determined using non-parametric tests for quantitative variables. We used the Kruskal–Wallis test and the Mann–Whitney test for associating socio-demographic characters with calculated scores, where the p-value was considered significant if P < 0.05.

Ethical Considerations

Ethical approval was obtained from the Ethics Committee of Umm Al-Qura University (Approval No. HAPO-02-K-012-2022-04-1053). Confidentiality and privacy were guaranteed for all participants. This study was conducted in full compliance with the Declaration of Helsinki. All participants provided informed consent prior to their involvement in the study. Before participation, all respondents were provided with an informed consent form outlining the study’s purpose, risks, and confidentiality measures. All participants provided written informed consent prior to their involvement in the study, in accordance with ethical standards and institutional guidelines.

Results

Socio-Demographic Characteristics of the Population

A total of 1172 questionnaires were collected. After excluding individuals under the age of 18, 1098 valid responses were finally included in this study with a response rate of (93.7%). The mean age of the respondents was 37.93 years (SD=11.185). The gender distribution was higher among female respondents, with a total of 756 responses (68.9%) compared to male respondents (n=342, 31.1%). The majority of respondents were Saudis (n=1047:95.3%) with Makkah region having the highest responses (n=623; 56.7%) followed by Riyadh region (n=193; 17.6%). The marital status of the respondents was mainly married with children (n=672; 61.2%), 281 (25.6%) were single, and 87 (7.9%) were married with no children. Of all survey respondents, more than 60% had a bachelor’s degree. The proportion of individuals who visit the Ministry of Health or Health Centers and National Guard or Military Hospitals for medical appointments account for 47.1% (n=517) and 29.6% (n=325), respectively, while those who visit Private Hospitals account for 19% (n=212). Only 21.6% of the study participants had chronic diseases, with which diabetes (6.6%) and hypertension (4.3%) accounted for the highest proportion (Table 1).

Table 1 Socio-Demographic Characteristics of the Population

Knowledge Levels Regarding PV and ADRs

Overall, the general public had low knowledge scores regarding PV and ADRs.

Greater than 70% (n=782) of participants had never heard of PV, and for those who had, social media was the main source from which they learned about PV. Hail (44%), Al Jawf (42%), and Makkah (31%) were the regions that had the highest percent of people who had heard of PV.

In addition, a significant number of respondents (n=968; 88.2%) did not know about NPC. More than 80% of respondents selected “Any effect of a medication”, representing inadequate understanding of ADRs, compared with only 16% (n=130) showing adequate understanding of ADRs. Although 67.1% (n=737) of participants agreed that not all the drugs marketed are safe, only 31.4% (n=345) were aware of the reporting procedure; among them, people who have children (33%) were more aware of the reporting procedure than others. In contrast, almost 70% of healthcare workers know that not all marketed medications are safe. The average knowledge score among participants was 37.8±18.5, where only 4.3% of respondents had adequate knowledge (Table 2 and figure 1).

Table 2 General Public’s Knowledge About Pharmacovigilance and ADRs

Figure 1 Boxplot of PV & ADR knowledge, attitude, and practice scores among participants (n=1098).

General Public’s Attitude Towards PV and ADRs

Positive attitudes were found for all questions related to attitudes toward PV and ADRs. More than 95% (n=1054) of respondents agreed to inform their healthcare provider if they experience ADRs. 21% and 14% of participants did not know whether PV helps improve drug safety or the importance of reporting ADRs to the NPC, respectively. More respondents (n=1038, 94.5%) demanded relevant departments carry out public-oriented activities to highlight the importance of reporting ADRs. Nearly all respondents (n=1029, 93.7%) agreed that the pharmacist and physician should inform patients about ADRs also as their responsibility in reporting ADRs. 92.4% (n=1015) of respondents urged the government to open channels for patients to report directly. The average attitude score was 90.1±19.2, where 83.4% had a positive attitude (Table 3 and figure 1).

Table 3 General Public’s Attitude Towards Pharmacovigilance and ADRs

General Public’s Practice Toward ADRs

Almost half of the respondents (n=597, 54.4%) have a family or personal history of ADRs. Among them, 50% discontinued the medication that caused the ADRs, 38% informed a healthcare professional, 3% changed the medication, 5% did nothing, and only 2% reported ADRs to NPC. Drug leaflet was the main source of information about ADRs for 79.7% (n=875) of respondents. Nearly 70% of female respondents report reading the drug leaflet compared to 50% of male respondents. More than half of the respondents (n=576, 52.5%) would not ask healthcare providers about ADRs. Most respondents (n=954, 86.9%) would actively report ADRs if they were familiar with the reporting procedure. 45.6% (n=501) preferred reporting ADRs directly to the healthcare providers, 31.1% (n=341) preferred telephone calls, and 23.3% (n=256) would like to report ADRs via the internet. The average practice score was 70.4±18, and 34.5% of participants had a good practice (Table 4 and figure 1).

Table 4 General Public’s Practice Towards ADRs

ADRs Reporting Barriers

For almost 90% (n=969) of respondents, unfamiliarity with the reporting process was the barrier to reporting ADRs. This was followed by a lack of adequate publicity of the ADRs reporting importance by the authorities for 87.1% (n=956) of respondents. Lack of knowledge about drugs or their effects and the uncertainty of the ADRs were almost equally a barrier for 82.4% and 85.0% of respondents, respectively. Lack of time to complete a report is seen as an obstacle to reporting ADRs by half of the respondents (n=560, 51.0%). Only 25.4% (n=279) of respondents felt that reporting well-documented ADRs was unnecessary (Table 5).

Table 5 ADRs Reporting Barriers

Factors Associated with Knowledge, Attitude, and Practice

As shown in table 6, knowledge score was significantly associated with the level of education (p=0.004) and working in the healthcare sector (p=0.000). The highest knowledge score was among holders of master’s degrees or higher (45.2±24.3) and those working in healthcare sectors (53.6±25.8). Attitude score was significantly associated with age (p=0.000), residency region (p=0.034), marital status (p=0.000), level of education (p=0.003), and working in the healthcare sector (p=0.002). The highest attitude scores were observed among the group aged 31–50 years (91.6±17.8), participants from Al Jawf (99.5±2.8), participants who are married with children (92.3±15.9), holders of master’s degrees of higher (92.3±15.9), and healthcare workers (93.2±18.1). Practice scores were significantly associated with marital status (p=0.020), as a higher score was among those who are married with children (71.7±17.4) and working in healthcare sectors (74±18.8) (p=0.014).

Table 6 Knowledge, Attitude, and Practice Scores in Association with Socio-Demographic Characters

Discussion

This study is believed to be the first to examine knowledge, attitude, and practice of PV and ADRs reporting barriers covering all regions within Saudi Arabia, unlike the other similar studies that focused on only certain regions.^4,5,14,27,28 Studies in this area have tended to target HCPs rather than the general public. This study aimed to assess the general population’s knowledge, attitude, and practice towards pharmacovigilance and ADRs reporting. With an 80/100 score threshold for adequate knowledge, we found that the majority of participants had inadequate knowledge (95.7%). Our knowledge results are consistent with a study that assessed the PV awareness of healthcare students.^29,30 Despite a positive perception of PV’s importance and a positive attitude toward PV and ADR reporting, PV knowledge was poor. According to Reumerman et al, many factors can influence PV competencies, including the type of education, academic level of study, and previous training.²⁹ According to our results, the level of education (p=0.004) and working in the healthcare field (p=0.000) were both significantly associated with knowledge scores. Individuals holding a master’s degree or higher (45.2±24.3) and those working in the healthcare sector (53.6±25.8) had the highest knowledge scores.

In one study where they assessed knowledge of ADRs among the general public, only around third of respondents had a good knowledge of ADRs reporting.³¹ In line with Wang et al findings, our study found that respondents’ knowledge of ADRs and reporting was poor.³¹ Moreover, PV was largely made known to participants through social media. By utilizing online sources, we can raise awareness associated with PV and ADRs, which will eventually improve public knowledge. On the other hand, social media has enabled patients and clinicians to share their experiences with medications, creating a valuable public database of information that has the potential to provide insights into medicinal product safety concerns.³² In addition to regulatory authorities, signals identified through social media could be used by pharmaceutical manufacturers, the healthcare system, or healthcare researchers.³³

NPC was unknown to almost 90% of participants which is comparable to the study’s findings conducted in Malaysia, where most participants did not know that their country had an ADRs reporting center.²⁷ Despite the huge effort made by the NPC in delivering promotional campaigns to the general public,³ this study suggests that gaps exist in which people have low awareness of NPC and further exploration is recommended. Only 16% of participants had properly understand what are ADRs. In the absence of understanding the nature of ADRs, people may not be able to recognize them, therefore not reporting them. 52% of respondents considered physicians to be the major source for reporting ADRs, which indicates that people in Saudi Arabia might not understand the pharmacist’s role regarding PV. The pharmacy profession is considered patient-oriented, so it is vital for pharmacists to gain their patients’ and customers’ trust in order to deliver effective communication that impacts the overall outcome of patients.³⁴

In our study, levels of positive attitude were high as 83.4% had an attitude score that is higher than 80%. Similarly, respondents of the general population in a study that took place in China showed a positive attitude toward ADRs reporting.⁵ Age (p=0.000), residency region (p=0.034), marital status (p=0.000), amount of education (p=0.003), and working in the healthcare industry (p=0.002) all had a significant relationship with attitude score. The group aged 31 to 50 years old (91.6±17.8), participants from Al Jawf (99.5±2.8), Participants who are married and have children (92.31±5.9), holders of a master’s degree or higher (92.3±15.9), and healthcare workers (93.2±18.1) had the best attitude scores. Another study showed that the level of education of a patient was associated with the patient’s willingness to report ADR directly.³⁵ These findings emphasize that respondents with a higher education level would report ADRs than those with lower education levels. Also, we found that most respondents in our study recognized the importance of PV and ADRs reporting; furthermore, they agreed that ADRs should be reported to NPC. Approximately 90% of respondents agree that relevant departments should hold public activities emphasizing the importance of ADR reporting. The same result was found in another study where people believed that HCPs and awareness campaigns seem to play a key role in increasing awareness of the PV and the importance of ADRs reporting.²⁷ A Saudi study regarding the use of technology to increase PV awareness and gain information about ADRs concluded that people are welcoming the idea.³⁶

According to our findings, 34.5% of respondents had good practice scores (>80%). Higher practice scores were seen among individuals who are married and have children (71.7±17.4) and those who work in the healthcare sector (74±18.8) (p=0.014). Almost half of the participant (52.5%) would not ask their HCPs about ADRs and 42.6% would discontinue treatment once they experience an ADR instead of reporting it, which may indicate that HCPs do not give the required attention to ADRs as one study shows that HCPS did not encourage their patients to report ADRs.¹⁴ A recent review described the medication information relevant to patients and showed that patients particularly desired safety-related information including ADRs and drug-drug interactions.³⁷ HCPs should give ADR-related information to help patients establish safe medication practices and urge them to report ADRs to a health professional in a timely manner if an ADR occurs. Different measures need to be considered to improve the communication between HCPs and patients which would improve the overall health outcome such as communication skills training to health care professionals.³⁸ In one study, more than half of the HCPs were unaware of the existence of NPC.²² Another study found that even with the good knowledge and positive attitude HCPs had, the majority of them had never reported ADRs before.³⁹ Due to underreporting of ADRs by HCPs, direct reporting by patients to the national PV center should be encouraged.³⁵

The majority of respondents in this poll responded that if there was a simple way to report ADRs, they would do so. Direct ADRs reporting to HCPs was the preferred way to report ADRs, which aligns with several studies.^4,40 Although the NCP made a free contact number to receive ADRs reports plus the availability of reporting forms on their website, most participants were not aware of their existence, which necessitates more publicity of communication means from authorities. Interestingly, over 70% of respondents agreed to report even the previously recognized ADRs, in contrast to another study in which participants believed that only major ADRs that disrupt daily life or necessitate hospitalization are worth reporting.⁴¹ More than 60% of participants would read the patient information leaflet which aligns with the findings of a study conducted in Spain.⁴² The ADRs section was most commonly read, and the information in this section was the most common specific reason given for reading the patient information leaflet according to one study.⁴³ More than 80% of participants feel that uncertainty about the ADRs is a barrier to whether to report ADRs or not. This is a higher percentage than a previous study where only 12.1% of respondents were uncertain about the ADRs.⁴⁴ Further development and wider availability of ADR-related information from HCPs plus reliable internet information, controlled by the authorities, could facilitate the general public in assessing suspected ADRs. Large number of respondents also claimed that the lack of proper advertising is the additional factor responsible for under-reporting ADRs. We recommend that direct patient ADRs reporting should be further promoted within the routine practice to support the existing spontaneous ADR reporting system.

Strengths and Limitations

Studies to explore the knowledge, attitude and practice regarding PV are limited in Saudi Arabia. Most studies in this regard were oriented toward HCPs rather than the general public. The strength of this study stems from the methodology as the study carefully constructed a questionnaire and developed a scoring system in order to perform inferential statistics to quantitatively investigate determinants of PV and ADRs knowledge, attitude, and practice. Also, the large number and diversity of participants improve the reliability of the results. However, the limitations of this study are that there was a higher risk of recall bias. A small sample in some regions makes generalization difficult because the participants may not represent the population of these regions.

Conclusion

This cross-sectional study was conducted among the general public and found that the majority of participants had inadequate knowledge, a positive attitude, and poor practice. Individuals holding a master’s degree or higher and those working in the healthcare sector had the highest knowledge scores, whereas the group aged 31 to 50 years old, participants from Al Jawf region, participants who are married with children, holders of a master’s degree or higher, and healthcare workers had the best attitude scores. Higher practice scores were seen among individuals who are married with children and those who work in the healthcare sector. We recommend future emphases on public education of pharmacovigilance and on how and when to report ADRs.