Public Awareness about Medicine Information, Safety, and Adverse Drug Reaction (ADR) Reporting in Dammam, Saudi Arabia

This study aimed to assess public knowledge about medicine information, safety, and adverse drug reaction reporting (ADR) in Dammam, Saudi Arabia. A cross sectional study was conducted using purposive stratified sampling in different settings of Dammam city for three months (January–March 2020). The target population was identified as consumers who had used the medicines in the last 3 months. The questionnaire was adopted from the literature and was validated. Content and face validities were established, and reliability was assessed. The study was approved by the concerned ethics committee. A total of 915 participants returned completed questionnaires. A total of 54.4% participants aged between 18 and 30 years, 65.8% were females and 53.1% had obtained bachelor level education. The mean score for knowledge of medicines (K1) was 5.46 ± 1.07. The mean score for knowledge regarding medication safety (K2) was 5.94 ± 1.73. The mean score for tendency to report a suspected ADR (T1) was 3.43 ± 1.57. Gender was a determinant of knowledge regarding medication safety (K2) (p < 0.01) and ADR reporting tendency (T1) (p < 0.01). The marital status of patients was a determinant for both knowledge of medicines (K1) (p < 0.01) and, knowledge regarding medication safety (K2) (p < 0.01). The results of this study highlighted that although the scores for knowledge of medicines, and tendency to report ADR were better, the score for knowledge regarding medication safety was unsatisfactory.


Introduction
One of the most important aspects of post marketing surveillance is the detection of adverse drug reactions (ADR) through spontaneous reporting (SR) [1]. Available evidence mentions the importance of patient reports as a credible source of information about the safety of new drugs [1]. Spontaneous reporting (SR) is a novel mechanism within the pharmacovigilance system to detect ADRs early; that were not reported previously. These ADRs could be rare and may be life threatening [1][2][3]. Ensuring patient safety is essential in sustaining the business of pharmaceutical industries. Notwithstanding the value of randomized controlled trials (RCTs) in evaluating potential medicines for their therapeutic and safety profile, the design of such studies makes it difficult to monitor ADRs since RCTs are usually conducted in a strictly defined population for a limited time period [1,[4][5][6]. Therefore, monitoring for

Questionnaire Development and Validation
A questionnaire was adopted from the available literature and was further developed and validated [19,20]. The final version consisted of close ended questions covering the demographic information, the use of medications, reading and understanding the PIL, and the perception of drug safety. Apart from the demographic section, the questionnaire had 3 sections: (1) knowledge of medicines, (2) knowledge of medication safety and, (3) tendency to report a suspected ADR. The questionnaire was translated in Arabic using a forward-backward translation method by native Arabic speakers whose second language was English. The questionnaire underwent content and face validation as well as piloting.
The content validity in Table 1 was conducted according to the Lawshe's method [21]. The content validity ratio (CVR) for items 2, 7, 12, 14 and 19, was 0.75. The CVR for all other items was 0.99. According to the criteria, CVR ≥ 0.75 was acceptable for each item [21]. The content validity index (CVI) was 0.93, i.e., acceptable. Furthermore, face validation was conducted via face-to-face review and some grammatical errors were rectified. The questionnaire was handed to 9 participants for piloting. No difficulty was reported in terms of understanding of the items. The pilot data were not included in the analysis.

Scoring of the Questionnaire
The questionnaire documented scores for three aspects of pharmacovigilance namely, knowledge of medicine (K1), knowledge regarding medication safety (K2) and tendency to report a suspected ADR (T1). The scoring criteria are presented in Table 2.

Data Analysis
The data were analyzed using SPSS version 23. Data were expressed as frequencies (n) and percentages (%). Where applicable, inferential statistics such as regression analyses were used to demonstrate the relationship between demographic variables and pharmacovigilance characteristics of participants.

Ethics Approval and Consent
Written informed consent was obtained from participants. The ethical approval was obtained from the Institutional Review Board (IRB) of Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia, (IRB-2020-05-018).

Results
A total of 915 responses were received, the majority of the participants were between 18 and 30 years old (54,4%), females (65.8%), all of the participants were educated but with different levels where (53.1%) had a bachelor's degree, more information about the participant demographics can be found in Table 3.

Medication Information
The mean score for knowledge of medicines (K1) was 5.46 ± 1.07 while the median was 6.0. Most participants (52.8%) had some medications without prescription and almost a quarter (24.9%) used them as a self-recommendation, followed by some who used them on the recommendation of pharmacist (20.4%). The participants were assessed for their knowledge about, indication, frequency, and duration of medication. The majority were aware of these (86.3%, 84.5%, 74%, respectively). More information about the participant medication information can be found in Table 4.

Medication Safety
The mean score for knowledge regarding medication safety (K2) was 5.94 ± 1.73 and the median was 6. Most of them indicated that they always read it (43.1%) or sometimes read it (49.6%), and only a few reported difficulty reading the PIL (7.3%). The majority was interested in reading the whole PIL (52.9%) but others participants specified other parts such as indication (19.7%), side effects (15.2%), dose and instructions (12.2%). The majority of participants knew about ADRs correctly (37.2%) but some participants (36.3%) answered "any effect of the medication". Almost a quarter (24.3%) answered "expected reaction after taking the normal dose". Few (2.3%) did not know what an ADR meant (Table 5).

Adverse Drug Reaction (ADR) Reporting Tendency
The mean score for tendency to report a suspected ADR (T1) was 3.43 ± 1.57 and the median was 4.0. Most (58.7%) believed that both consumers and health care professionals (HCPs) should report ADRs. Some (39%) mentioned that it was the responsibility of the HCP only while a small segment (2.3%) believed it was consumers responsibility. Some participants had a previous ADR experience (16%) and those who had suffered, either reported it to HCPs (8.1%) or did not report it to any facility (7.8%). One participant did report it to the Saudi National Pharmacovigilance Center (NPC). Regarding the participants knowledge about the Saudi NPC, the overwhelming majority of people were not familiar with the center's existence (91%). They also believed that this option should be available to the public (93.1%), and they expressed their interest to know more about the Saudi NPC (90.5%) ( Table 6). Bivariate analysis revealed that the mean score for knowledge of medicine (K1) was higher in patients above 45 years, those who were employed, and married. The variables of gender and education were not significantly associated with K1. The knowledge about medication safety (K2) was higher in married female patients below 45 years. The variable of education was not significantly associated with K2. The tendency to report a suspected ADR (T1) was higher in married female patients. All other demographic variables were non-significant for T1. The details are mentioned in Table 7.
Multivariate analysis revealed that gender was a determinant of knowledge regarding medication safety and male patients were more likely to have lower knowledge. In addition, the marital status of patients was also a determinant for both knowledge of medicines and knowledge regarding medication safety. Married patients were more likely to have better knowledge about medicines and their safety. The variables of age and employment were non-significant (Table 8).

Discussion
In our observation, most participants were either self-medicating or had their medications advised by a pharmacist. In a study it was observed that most patients in Saudi healthcare settings seek counseling from pharmacists [22]. Moreover, a dedicated drug information service is available in healthcare settings of the Dammam region [23]. The score indicated adequate knowledge about medication use which was in line with the results reported by Salgueiro et al. [20]. The score suggests good knowledge about medications among patients who were above 45, employed and married. Henceforth, this knowledge could result from more frequent use of prescribed medication in older age-groups. Employed participants may have better opportunities to learn about medicines by exchange of information with colleagues and information about medical insurance they are usually entitled to at the workplace. Similarly, being in a marital relationship allows both participants to be exposed to their medical history, apart from the knowledge exchange. Studies have highlighted that a spouse's influence may lead to their partners improving their health behaviors [24,25]. Therefore, marital support may have some role in improvement of knowledge regarding medicines. Though, this hypothesis may require further investigation.
The majority (43.1%) of participants reported that they always read the PIL which aligns with the findings of several studies from other countries [20,26,27]. A study in Spain mentioned that 61.4% of participants always read the PIL [20]. A study in England reported that 41.9% of respondents always read the PIL [26]. A study in USA reported that 49.2% of participants always read the PIL [27]. Most participants (52.9%) in this study emphasized their interest in reading the whole PIL, however, other studies showed that the section pertaining to the side effects is the most read part of PIL [26][27][28]. A study by Krska and Morecroft reported that 37.7% of participants in England read the PIL section related to side effects [26]. While a study by Nathan and colleagues reported that 60.7% of respondents in the USA read the same section of the PIL [27]. Raynor and colleagues mentioned that 60-66% participants in the UK read the section related to side effects [28]. A study in UK examined PIL for appropriateness of information related to ADR risk presentation and found that few leaflets had this information according to the guidelines [29]. In this study, only 15.2% of participants read the side effects section, while the section that was read by most respondents (19.7%) was the indication of the medicine. Only few reported having difficulty reading and understanding the PIL.
Most participants (37.2%) accurately defined ADRs, however some were confused about the ADR meaning. This finding was in contrast to those reported by Sales et al. in Riyadh where majority defined ADR incorrectly and only a quarter (25.7%) knew the correct definition [19]. The score indicated a satisfactory knowledge of medication safety among participants. Further, it was evident that respondents had an interest in asking about possible ADRs of medicines they used. They showed interest in seeking information from the most common platforms, namely the internet, as well as the PIL, followed by healthcare professionals (HCPs) such as doctors and pharmacists. The majority mentioned that both HCPs and the consumers were responsible of reporting ADRs, though it was observed that a large number of participants rely on HCPs as responsible persons to report potential ADRs. In the study by Sales and colleagues, most respondents (73.2%) mentioned that ADR reporting should be done by HCPs [19].
Previous studies show a low tendency of ADR reporting among HCPs as well as their knowledge about the SNPC [30][31][32]. Therefore, it is imperative that both HCPs and consumers be educated about the process of reporting of ADRs. Mahmoud and colleagues mentioned the need to formulate interventions to improve knowledge of ADR reporting [32]. The study reported that less than 10% of participants were aware of the SNPC which was even lower than the figure reported by sales et al., i.e., 15.1% [19]. Alharf et al. mentioned that awareness regarding NPC could be created among HCPs through workshops. Moreover, establishment of regional committees to facilitate a knowledge exchange between NPC and HCPs would enhance communication [10]. The results of this study have policy implications as they have highlighted that the public has a low awareness about the NPC. Alharf et al. mentioned that social media could be helpful in disseminating information among the masses [10]. Therefore, various social media platforms could be used to provide awareness. In addition, communicating with HCPs to educate patients about the NPC and ADR reporting process during counseling could be very helpful in increasing ADR reporting. The results of this study highlighted that females had a greater tendency to report ADRs. This notion directs the attention to the male members of the public and targeting this stratum with the abovementioned interventions may greatly improve the outcome.
In summary, this study highlighted that a positive attitude exists among the general public towards ADR reporting. Moreover, the general public was welcoming to the idea of receiving further education about this process. The study had a limitation of sampling as it gathered few responses from geriatrics and participants who were employed in the health sector. The addition of responses from those participants would have improved the representativeness of the study and might have further clarified the findings. Nonetheless, the sample size and choice of statistical techniques used to elaborate the findings from this population are strong enough to highlight the phenomenon with significance.

Conclusions
The results of this study highlighted that although the population had a high score for knowledge of medicines and tendency to report ADRs, the score for knowledge regarding medication safety was unsatisfactory. The results suggest that further education should be conducted for the population of Saudi Arabia regarding the Saudi NPC and the ADRs reporting system. The attitude of the general public towards medicine knowledge seeking and ADR reporting was positive.