Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports.

PURPOSE: This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects. METHODS: A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports. RESULTS: During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recalls of defective products. Innovator pharmaceutical companies requested voluntary recalls more often than generic pharmaceutical companies. CONCLUSION: The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.

Proton pump inhibitor prescribing patterns and utilization: A retrospective chart review analysis.

Introduction: Proton pump inhibitors (PPIs) show a high level of efficacy and a high safety profile, and they have been increasingly prescribed in recent years. However, recent pharmacoepidemiological evidence has shown that PPI use has been associated with health risks and complications. Objectives: This study aimed to assess the prescribing patterns of proton pump inhibitors and the prevalence of potential drug-drug interactions (DDIs) among patients who use PPIs. Method: This was a retrospective analysis of electronic health records from the Ministry of National Guard Hospitals in Riyadh from January 2019 to June 2022. All adult patients who used PPIs were included to assess the prescribing patterns and drug utilization, including the number of prescriptions, duration of prescriptions, number of doses, and prescription indications. Potential DDIs were assessed based on concurrent use, which is defined as taking an interacting drug parallel to PPIs. The assessment includes complete or partial overlapping, with at least one day of overlapping. Results: The total number of PPI prescriptions was 80,365 for a total of 9,930 patients with a mean age of 67.5. The majority of PPIs were prescribed in high doses (74%), without reporting appropriate indications (95%), and 17% were prescribed for long-term use. A total of 24,575 (33.6%) potential DDIs with PPIs were found. Conclusion: The results showed that the majority of the PPI prescriptions were made with a high number of doses, without reporting appropriate indications, with some having potential DDIs. This might result in exposing patients to an increasing number of health risks. The findings highlight the importance of implementing a stewardship program for PPI prescription with periodic reassessments of patients' needs for these medications.

The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets.

Introduction: Drug recalls may impact treatment plans or access to suitable therapies. Thus, they inadvertently affect treatment outcomes. Objective: We aimed to examine the impact of recalls on patients' safety using pantoprazole-containing products recall as a case study in terms of the occurrence of potential drug-drug interactions (pDDIs). Methods: This retrospective study used de-identified electronic health records of adult patients who had a prescription for oral proton pump inhibitors (PPIs) including pantoprazole, esomeprazole, lansoprazole, or omeprazole from April 2020 through September 2021 from a large tertiary care hospital. The study outcome definition was the prevalence of pDDIs in PPIs users before and after the recall date (March 2021). Changes in the prevalence of pDDIs were modeled using interrupted time-series. The rate ratio of pDDIs in the 12 months before and 6 months after the recall was modeled using negative binomial regression. Results: A total of 1,826 pDDIs were identified, and the median monthly prevalence of pDDI before the recall was 102.5 which increased to 115.5 after the recall. A change in the level of pDDIs occurred immediately after the recall date, followed by a gradual decrease over time. The rate of pDDIs was 69% higher after the recall compared to the baseline (rate ratio 1.69; 95% confidence interval, 0.75-1.91). Discussion: Recall of pantoprazole-containing products was associated with a higher rate of pDDIs. However, the prevalence of pDDIs gradually decreased over time. We highlight the importance of planning of recall process and coordinating all potential stakeholders to avoid potential harms.Word count: 1450.

Vaccine hesitancy in the Gulf Cooperation Council countries.

Background: Vaccination has a tremendous impact on health at the regional and global levels, however, the tendency for people to hesitate on vaccination has been increasing in the past few decades. Aims: We assessed vaccine hesitancy and its determinants in the Gulf Cooperation Council countries. Methods: We conducted a literature review to assess peer-reviewed articles published up to March 2021 on vaccine hesitancy in the Gulf Cooperation Council countries using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses approach. A search was conducted via PubMed and 29 articles were identified. After the removal of duplicates and irrelevant articles, 14 studies remained relevant and were used for the review. Results: Vaccine hesitancy in the Gulf Cooperation Council countries ranged from 11% to 71%. Differences in rates were noted for vaccine type, with COVID-19 vaccine having the highest reported hesitancy (70.6%). The likelihood of accepting vaccination was associated with previous individual acceptance of vaccine, specifically the seasonal influenza vaccine. The most common determinants of vaccine hesitancy were distrust in vaccine safety and concerns about side-effects. Healthcare workers were among the main sources of information and recommendations about vaccination, but 17-68% of them were vaccine-hesitant. The majority of the healthcare workers had never received any training on addressing vaccine hesitancy among patients. Conclusions: Vaccine hesitancy is prevalent among the publics and healthcare workers in the Gulf Cooperation Council countries. There is a need to continually monitor perceptions and knowledge about vaccines and vaccination in these countries to better inform interventions to improve vaccine uptake in the sub-region.

Readability of information imprinted in patient information leaflets (PILs) in Saudi Arabia: The case of antihypertensive medications.

Background: The Saudi Food and Drug Authority (SFDA) requires marketing authorization holders to submit a PIL in both Arabic and English language. However, the readability of imprinted and disseminated Patient information leaflets (PILs) was not assessed extensively in Saudi Arabia. This study aims to assess the readability of PIL of antihypertensive drugs in both Arabic and English languages. Method: This study was a descriptive quantitative analysis conducted in Saudi Arabia in August 2021. PILs of all oral antihypertensive medications in Saudi Arabia were included in the study. The Arabic and English PILs were extracted from the Saudi Drugs Information System (SDI) and pharmaceutical companies' registration documents. The study used Flesch-Kincaid grade level to assess the readability of English and sentence length to assess the Arabic texts. Descriptive analyses were used to assess the readability scores and the mean differences. Results: It was found that almost 88% of English PILs were above recommended readability level compared to 79% of Arabic PILs. About 89% of English PILs of generic and 86% of brand-name medications were above the readability cutoff point compared with 83% of Arabic PILs of generic and 68% of brand-name medications. The means of grade level for readability of PILs for the widely used antihypertensive medications including angiotensin II receptor blockers (ARBs), antiadrenergic, diuretics, Beta-blockers (BBs), calcium channel blockers (CCBs), and combination antihypertensive medications, and CCBs were higher than the recommended readability level (p < 0.05). The highest mean grade level for readability among English PILs was for combinations of antihypertensive agents (9.35 ± 1.38, p 0.01) and among Arabic PILs was for ARBs (6.15 ± 1.62, p < 0.01). Conclusions: The majority of PILs of antihypertensive medications were above the recommended readability level that can be understood by the majority of the public, especially among generic medications and the most widely used antihypertensive medications. The study findings highlight the need of implementing guidelines to improve the readability of information imprinted in PILs and adopt new regulations requiring readability assessment for manufactures before submitting the PILs to the SFDA.

The impact of using pictorial aids in caregivers' understanding of patient information leaflets of pediatric pain medications: A quasi-experimental study.

Introduction: Patient information leaflets (PILs) are one of the main sources of information for over-the-counter medications (OTCs). This study aimed to assess caregivers' understanding of instructions in PILs provided with paracetamol medications and the impact of pictograms use. Methods: A quasi-experimental study was conducted among caregivers of children aged < 13 years recruited in pediatric outpatient clinics at University Medical City in Riyadh. The calculated sample size was 128; at least 64 participants were needed in each group (the text-only group and the text-plus pictograms group). Caregivers' health literacy was assessed using a validated Arabic version of the Newest Vital Sign scale. Participants' understanding of PILs instructions was assessed using eight questions on the route of administration, minimal hours between doses, max daily dose, shake medication before use, storage, and reporting adverse events; and was rated based on the number of questions correctly understood. Characteristics of participants were compared by Pearson X2 and t-test was used to assess the significance of mean score differences between groups. Results: A total of 130 caregivers participated in the study; almost half of them were mothers (47%, [n = 61]) and 43% (n = 56) have "a possibility of limited health literacy". The mean number of correct answers to questions assessing the understanding of PILs instructions was significantly higher among the text-plus pictograms group compared to the text-only group (5.25 ± 1.85 vs. 4.38 ± 1.27; p < 0.001). When results were controlled for age and gender, better health literacy was found to be associated with a better understanding of instructions (B = 0.39, 95 %CI 0.23-0.54). Conclusion: Limited comprehension of medications instructions was observed; adding pictorial aids to PILs might enhance the comprehension. Differences in health literacy levels of caregivers should be considered when designing PILs.

Willingness and determinants of participation in public health research: a cross-sectional study in Saudi Arabia.

BACKGROUND: Active participation in health research plays an integral role in the development and implementation of evidence-based health interventions and policies. AIMS: To assess public willingness and determinants of participation in public health research. METHODS: A cross-sectional survey targeting Saudi residents aged > 16 years from the 13 regions of Saudi Arabia, using computer-assisted telephone interviews. We assessed the sociodemographic of participants, participants' involvement in research, their acceptance to participate, barriers hindering their participation, and their willingness to be involved in future health research. Pearson's χ2 and logistic regression analyses were used to explore determinants. RESULTS: There were 2512 participants in this study. Three hundred and seventy one (14.8%) confirmed that they had been invited previously to participate in research studies and 271 (73%) accepted the invitation. The majority (92%, n = 2319) of participants were willing to participate in future research. Being a young adult, male, college-educated, and employed were the main factors associated with willingness to participate in health research. Those who had previous experience of participation in health research were 3 times more willing to participate in future health research compared with participants with no prior experience (P < 0.001). CONCLUSIONS: This study highlighted the key determinants of willingness to participate in health research. Most participants had never been invited to participate in health research, but the majority reported a positive attitude towards participation. With rapid health system development nationally and regionally, Saudi participation levels in health research still need improvement.

Treatment adherence among patients with hypertension: findings from a cross-sectional study.

BACKGROUND: Hypertension is a major risk factor for cardiovascular disease, which is the leading cause of mortality globally. Patient's adherence to treatment is a cornerstone factor in controlling hypertension and its complications. This study assesses hypertension patients' adherence to treatment and its associated factors. METHODS: This cross-sectional study conducted in Riyadh, Saudi Arabia. The study targeted outpatients aged ≥18 years who were diagnosed with hypertension. Participants were recruited using a systemic sampling technique. The two main measurements were assessing adherence rate of antihypertensive medications using Morisky scale and identifying predictors of poor medication adherence among hypertensive patients including socio-economic and demographic data, health status, clinic visits, medication side effects, medications availability, and knowledge. Descriptive and logistic regression analyses were performed to assess factors associated with poor adherence. RESULTS: A total of 306 hypertensive outpatients participated in this study. 42.2% of participants were adherent to antihypertensive medications. Almost half of participants (49%) who reported having no comorbidities were adherent to antihypertensive medications compared to participants with one or more than one comorbidities 41, 39% respectively. The presence of comorbid conditions and being on multiple medications were significantly associated with medication adherence (P-values, respectively, < 0.004, < 0.009). Patients with good knowledge about the disease and its complications were seven times more likely to have good adherence to medication (P <  0.001). CONCLUSIONS: Non-adherence to medications is prevalent among a proportion of hypertensive patients which urges continuous monitoring to medication adherence with special attention to at risks groups of patients. Patients with comorbidities and on multiple medications were at high risk of medication non-adherence. Patients' knowledge on the disease was one of the main associated factors with non-adherence.

Waterpipe Tobacco Chemical Content, Microbial Contamination, and Genotoxic Effects: A Systematic Review.

The spread of tobacco smoking has increased over time at the global and national levels. One of the widely spread tobacco products is waterpipe. Recent studies showed that waterpipe tobacco smoke contains toxic substances, including carbon monoxide and nicotine. Some of them are genotoxic carcinogen, such as formaldehyde. This study aims to provide comprehensive insight into the types and depth of the scientific literature on waterpipe tobacco smoke chemical content, its genotoxic effects, and waterpipe device microbial contamination. We conducted a systematic comprehensive review of articles published between 1986 and December 2018. Primary research articles focusing on the content of waterpipe smoke, including chemical, genotoxic, and microbial contaminants, were eligible for inclusion. Of the 1,286 studies generated, 22 studies were included. Twenty-three chemical families were extracted from waterpipe smoke. Aldehydes were the most identified chemical family in 6 studies, and next is polycyclic hydrocarbons, found in 5 studies. About 206 chemical compounds were identified. Flavobacterium, Pseudomonas, coagulase-negative Staphylococci, and Streptococcus were the most abundant pathogen contaminants. Waterpipe smoke had elevated levels of many DNA damage markers (8-hydroxy-2'-deoxyguanosine and cytochrome P450 1A1) and inhibited levels of many DNA repair genes (OGG1 and XRCC1) in waterpipe smokers. Waterpipe smoke is associated with the genotoxic effect, which elevates the levels of many DNA damage markers and inhibits the levels of many DNA repair genes. In addition, waterpipe smoking can expose smokers to a range of pathogenic bacteria.

Health literacy in Saudi Arabia: Implications for public health and healthcare access.

This study aims to describe the distribution of low health literacy (HL) in the population in the Kingdom of Saudi Arabia (KSA), and to analyze factors associated with low HL in KSA. A cross-sectional national survey using quota sampling, population-based of residents of KSA conducted via phone interviews supplemented by in-person interviews. The survey included an overall evidence-based measurement of HL. Both descriptive statistics of the sample and a multivariable logistic regression model predicting low HL were developed. A total of 3557 surveys were available for analysis, and 46% of the respondents were classified as having low HL. In regression modelling, low HL was associated with older age groups (age 47-56 odds ratio [OR] 1.60, 95% confidence interval [CI] 1.30-1.97; age 57-66 OR 1.38, 95% CI 0.98-1.94), the regions of Ha'il (OR 0.65, 95% CI 0.5-0.85) and Najran (OR 1.27, 95% CI 0.99-1.64), having been formerly married, lower levels of education (less than elementary OR 3.20, 95% CI 2.10-4.88; and elementary, OR 1.62, 95% CI 1.14-2.30), lower levels of income, and having sought healthcare exactly three times in the last year. Approximately half of KSA has low HL, and risk factors for low HL were older ages, lower income and education, having been formerly married, and a moderate pattern of health use. Future studies are needed to better characterize the distribution and determinants of low HL across KSA.