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.

Physical activity status and its association with quality of life among children with down syndrome in Saudi Arabia: A comparative cross-sectional study.

BACKGROUND: Down syndrome is a genetic disorder that causes physical and cognitive challenges. Identifying the impact of sedentary behavior and physical activity on people with Down syndrome is crucial for early intervention. The purpose of this study is to compare physical activity and sedentary behavior among children with Down syndrome and typically developing children, as well as assess their relationship with quality of life. METHODS: In the cross-sectional study, 67 children between the ages of 6 and 12 were enrolled: 29 in the Down syndrome group and 38 in the typically developing group. Each child wore an ActiGraph wGT3X-BT for seven days. Accelerometer data and quality of life data were analysed. RESULTS: Physical activity and sedentary behavior were not significantly different between the Down syndrome and typically developing groups (p ˃ .05). With large effect sizes (partial eta squares ranging from 0.21 to 0.59), typically developing children had a significantly better quality of life than children with Down syndrome. There was a weak positive correlation between moderate physical activity and school performance in children with Down syndrome. For typically developing children, there is a weak negative correlation between light physical activity and physical function, school function, and total paediatric quality of life scale scores. CONCLUSIONS: This study indicates that children with Down syndrome have participated in more physical activities, resulting in a reduction in differences between them and typically developing children. Additionally, typically developing had higher quality of life than children with Down syndrome. For healthcare professionals and educators, these findings provide valuable insights into developing strategies to enhance physical activity for children with developmental disabilities.

Walking capacity and its association with quality of life among children with down syndrome in Saudi Arabia.

BACKGROUND: Walking ability, which has been connected to better health and independence, is one of the daily activities that is negatively impacted by Down syndrome. Thus, the objective of this study was to examine the walking capacity and its association with the quality of life of children who have Down syndrome compared to those who do not have Down syndrome in Saudi Arabia. METHODS: For this cross-sectional study, we recruited 68 Arabic-speaking children aged 6 to 12 using a convenience sampling method from August to November 2021. Children were divided into two groups: those who do not have Down syndrome (n = 38) and those who have Down syndrome (n = 30). Children in the Riyadh region of Saudi Arabia who do not have Down syndrome were chosen randomly from two schools. Children who have Down syndrome were selected from multiple associations and centers in the same region. A 6-minute walk test was used to measure the child's walking capacity. The Arabic version of the Pediatric Quality of Life Inventory scale was used to assess the child's or parent's perceptions of the child's quality of life and its physical, emotional, social, and school functioning domains. RESULTS: The difference in the mean 6-minute walk test scores between children who have and who do not have Down syndrome was statistically significant, with a mean difference = 105.6, 95% confidence limit = 57.2-154.0, p < .0001. The linear regression analysis after adjusting for age, height, weight, and body mass index revealed that walking capacity was found to be significantly associated with the worst score on the Pediatric Quality of Life Inventory scale (ß = -2.71, SE = 0.49, p < .0001) and its domains of physical, social, and school functioning (ß = -2.29, SE = 0.54, p < .0001; ß = -2.40, SE = 0.58; p = .001; ß = -3.71, SE = 0.56, p = .002, respectively) in children who have Down syndrome, but they had better emotional functioning than children who do not have Down syndrome. CONCLUSIONS: Children who have Down syndrome were less able to walk and were highly associated with the worst possible quality of life, which included the lowest levels of physical, social, and school functioning. Early interventions with techniques must be developed to improve the quality of life for these children.

Effect of glycerol concentration on levels of toxicants emissions from water-pipe tobacco smoking (WTS).

Glycerol, flavorings and sweeteners constitute approximately 70% of water-pipe tobacco smoking (WTS) mixtures. Tobacco mixture combustion produces smoke toxins (e.g. carbonyl compounds), of which the type and amount are highly dependable on tobacco mixture formula. While glycerol in tobacco mixture contribute to enhanced smoking experience, its' combustion produces toxicants such as acrolein. According to WHO, there are no approved international upper limits regulations on WTS ingredients. This study aims to assess toxicant emission levels corresponding to increasing glycerol concentration in WTS mixtures, which may aid in developing tobacco regulations towards harm reduction.MethodsLaboratory experimental study. Using laboratory water-pipe smoking machine, levels of toxicant emissions in the smoke from WTS mixture samples containing varying glycerol concentrations were measured using High-performance Liquid Chromatography (HPLC). Smoke from 5 consecutive smoking cycles with 35 puffs each (ISO 22486 standard) was led through a trapping system as described in the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) recommended method No. 74 (Determination of selected carbonyls in mainstream cigarette smoke by HPLC). Trapped carbonyls were then analysed by HPLC with a DAD detector.ResultsAcrolein emission is associated with glycerol addition in WTS mixture indicated by lab-made samples throughout all glycerol concentrations (10%, 20%, 40% and 60%), and brand samples with glycerol concentrations 10% to 20%. However, brand samples showed no increase in acrolein emission corresponding to the increase in glycerol concentrations from 20% to 60%.ConclusionThe effect of glycerol addition in waterpipe tobacco on acrolein emission varies between products. Tobacco fillers, additives and contents quality and other factors may affect toxicant emission levels. Therefore, regulatory recommendations towards defining upper limits of content concentrations require further investigations regarding potential confounders in acrolein emissions and health effects of market-available glycerol concentrations in waterpipe tobacco smoking.

Determinants of Vaccine Hesitancy among Home Health Care Service Recipients in Saudi Arabia.

BACKGROUND: Vaccine hesitancy has been identified by the World Health Organization (WHO) as a major worldwide health threat. Home Health Care (HHC) service recipients represent a vulnerable group and were prioritized to receive coronavirus disease (COVID-19) vaccination during the national vaccine campaigns in Saudi Arabia. We aimed to investigate the most frequent reasons for vaccine hesitancy among home health care recipients in Saudi Arabia. METHODS: This cross-sectional survey was conducted among home health care (HHC) service recipients in Saudi Arabia from February 2022 to September 2022. The behavioral and social drivers (BeSD) model developed by the WHO was used to understand the factors affecting vaccination decision making in our cohort. RESULTS: Of the 426 HHC service recipients enrolled in the study, a third were hesitant to complete the COVID-19 vaccination series. The most prevalent reported reason for COVID-19 vaccine refusal was concerns about the vaccine side effects (41.6%). Factors independently associated with COVID-19 vaccination hesitancy were: having chronic conditions (odds ratio [OR] = 2.59; 95% confidence interval [CI] = 1.33-5.05, p = 0.005), previous COVID-19 diagnosis (OR = 0.48; 95% CI: 0.28-0.82, p = 0.008), ease of getting the COVID-19 vaccine by themselves (OR = 0.49; 95% CI: 0.28-0.89, p = 0.018), belief in the importance of COVID-19 vaccine in protecting their health (OR = 0.60; 95% CI: 0.38-0.96, p = 0.032), and confidence in the safety of COVID-19 vaccination (OR = 0.38; 95% CI: 0.21-0.69, p = 0.001). CONCLUSION: Only one-third of the study participants were hesitant to complete the series of COVID-19 vaccination. Understanding the factors underpinning vaccine hesitancy among this group would help healthcare workers and policymakers in developing personalized health awareness campaigns aimed at improving vaccine acceptance levels.

Online Arabic Beverage Frequency Questionnaire (ABFQ): evaluation of validity and reliability.

BACKGROUND: Obesity and chronic diseases are significant public health issues in the Middle East and North Africa region. A robust body of evidence demonstrated the association between beverage consumption, obesity, and chronic diseases. Therefore, the assessment of beverage consumption is gaining more interest in health policy development, food industry partnerships, research expansion and community involvement. Although beverage-consumption assessment tools have been developed for various populations, none were developed for the Arabic population. In this study, we developed and validated an online Arabic Beverage Frequency Questionnaire (ABFQ) to assess the total beverage intake among Arabic speaking population. METHODS: A cross-sectional validation study was conducted among healthy adults aged between 18 and 55 years. Participants (n = 49) completed a 24-item ABFQ on two occasions and provided one 24-h urine sample. For validity, total beverage consumption (ABFQ1) was assessed against a 24-h urine sample using an osmolality test and correlation analysis. Reliability was assessed by comparing the participants' consumption in total and for every 24 individual items from ABFQ1 with the total and individual items in ABFQ2 using correlation and paired sample t-test. RESULTS: The average daily consumption of beverages was 1504 ml/day, while the average urine osmolality/kg was 614. The validity assessment between ABFQ and urine osmolality indicates a negative correlation. However, the correlation was week and not statistically significant (rs = -0.2, p = 0.12). In reliability test, correlation analysis was positive and acceptable in all beverage categories (rs = 0.4 - 0.9; all p < 0.05) except flavored milk (rs = 0.2; p < 0.181) and sweetened coffee (rs = 0.3; p < 0.022). Furthermore, no significant differences were found between the means of total consumption in both ABFQ1 and ABFQ2. CONCLUSIONS: The finding of this study suggest that the ABFQ is a reliable reproducible tool for assessing beverage consumption among Arabic-speaking consumers. However, the survey could not be validated using 24-h urine osmolality only and other methods such as multi dietary records may use in future re-assessment.

The Prevalence of Vitamin and Mineral Deficiencies and High Levels of Non-Essential Heavy Metals in Saudi Arabian Adults.

Although the micronutrient status of a population is of high national priority, as it critically impacts public health, limited data is available for quantifying the micronutrient status in Saudi Arabia. We aimed to provide comprehensive, epidemiological, descriptive data regarding micronutrient levels in Saudi adults. This cross-sectional study included 3432 adults aged ≥18 years (mean age, 37.7 ± 11.7 years; women, 51.2%) across all 13 Saudi administrative regions (March 2019-November 2021). Laboratory data for 14 micronutrients (8 vitamins, 4 minerals, and 2 nonessential heavy metals) were characterized using descriptive analysis. Vitamin D deficiency (64.3%) was the most prevalent, followed by vitamin B2 (44.9%) and A (9.6%) deficiencies. Among minerals, iron deficiency was the most prevalent (23.2%), followed by zinc (15.3%) and copper (8.7%) deficiencies. Most Saudi adults exhibited normal arsenic (99.7%) and mercury (99.9%) levels. Men exhibited significantly higher vitamin B2, B9, and D deficiencies than women, while women exhibited higher vitamin A, B12, iron, and zinc deficiencies than men. Younger adults demonstrated a significantly higher prevalence of vitamin D and iron deficiencies, whereas older adults exhibited a higher prevalence of vitamin B1 and magnesium deficiencies. As micronutrient deficiencies are a public health concern, health policies and programs need to be developed and implemented to address them.

Predictors of Mortality in Home Health Care Service: Data from Saudi Arabia.

Objective: This study aimed to 1) report the prevalence of chronic conditions among Saudi people receiving long-term home health care (HHC) services, 2) identify the predictors of mortality among individuals receiving long-term HHC services, and 3) study the association between frailty and poor health outcomes among HHC users. Design: Retrospective cross-sectional descriptive study. Setting and Participants: A total of 555 participants were recruited from HHC services at King Saud University Medical City (KSUMC), Riyadh, Saudi Arabia. We collected the data from electronic health records (EHR), patient charts, and caregiver interviews for 555 participants included in HHC program from the year 2019 to 2022. Methods: Only individuals fulfilling the HHC program's eligibility criteria were included to the study. A total of 555 participants were included in the analysis. We assessed the functional performance by the Katz activity of daily living and Bristol Activity of Daily Living Scale (BADLS). A trained health care provider assessed frailty using the Clinical Frailty Scale (CFS). We calculated the means and frequency to describe the prevalence of chronic conditions and variables of interest. A Chi-square test or independent-samples t-test was run to determine if there were differences between the alive and deceased individuals. A binary logistic regression model was performed to predict mortality of HHC service recipients. Results: The mean age for deceased individuals in HHC was 78.3 years. Over twenty percent of individuals receiving HHC services were readmitted to the hospital. We found that the strongest predictors for mortality were pressure ulcers with an odds ratio of 3.75 and p-value of <0.0001, and the Clinical Frailty Scale, which had an odds ratio of 1.69 and p-value of 0.002, using multivariate regression analysis. Conclusions and Implications: In conclusion, our study found that pressure ulcers and frailty are the strongest predictors of mortality for individuals receiving home health care services.

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.

Demographic Characteristics and Status of Vaccinated Individuals with a History of COVID-19 Infection Pre- or Post-Vaccination: A Descriptive Study of a Nationally Representative Sample in Saudi Arabia.

BACKGROUND: Saudi Arabia expedited the approval of some COVID-19 vaccines and launched mass vaccination campaigns. The aim of this study was to describe the demographics of vaccinated COVID-19 cases and compare the mortality rates of COVID-19 cases who were infected post-vaccination in Saudi Arabia. METHODS: This was a retrospective cohort study. We retrieved data for COVID-19 cases who were infected pre- or post-vaccination and had received at least one injection of the Oxford-AstraZeneca or Pfizer-BioNTech vaccine from 4 December 2020 to 15 October 2021. RESULTS: The number of patients who were infected and had received at least one dose of a COVID-19 vaccine was 281,744. Approximately 45% of subjects were infected post-vaccination, and 75% of subjects had received the Pfizer-BioNTech vaccine. Only 0.342% of the patients who were infected post-vaccination died, and 447 patients were admitted to ICUs. Most of the patients who were infected with COVID-19 post-vaccination and were admitted to ICUs (69.84%) had received only one dose of the vaccine (p < 0.0001). The mean time to infection for patients who had received one and two doses of the Oxford-AstraZeneca vaccine were 27 and 8 days longer than their counterparts who had received one and two doses of Pfizer-BioNTech vaccine, respectively. No difference in the odds of mortality between the Pfizer-BioNTech and Oxford-AstraZeneca vaccines was found (OR = 1.121, 95% CI = [0.907-1.386], p-value = 0.291). Patients who had received two doses of the vaccine had significantly lower odds of mortality compared to those who had received one dose (p < 0.0001). CONCLUSIONS: Vaccines are vital in combating the COVID-19 pandemic. The results of this study show no difference between the Pfizer-BioNTech and Oxford-AstraZeneca vaccines in the rate of mortality. However, the number of vaccine doses was significantly associated with a lower risk of mortality. Future studies should examine the effectiveness of different COVID-19 vaccines using real-world data and more robust designs.

Consumer Behavior at Supermarkets during Grocery Shopping in Saudi Arabia: A National Observational Study.

BACKGROUND: Use of nutrition facts labels can be associated with healthier eating behaviors; however, consumers currently face difficulty understanding these labels or do not use them often. Thus, improving healthy grocery shopping behaviors among consumers might increase the overall health of the community. AIM: The study aims to explore consumers' behavior during grocery shopping and measure their basic knowledge regarding food product labels. METHOD: A national observational study (cross-sectional) was carried out on a convenience sample of Saudi Arabian residents aged 18 years and above. The data were obtained from all 13 administrative regions in Saudi Arabia at three different major supermarkets in each region. The data were analyzed using descriptive analysis, and binary logistic regression was used to investigate behavior variables. RESULTS: A total of 12,675 participants were observed; of those, 52.2% did not interact with the product before putting it in their shopping cart. The study found that the production date (66.6%) and expiry date (51%) were the most frequently checked aspects of food labels; they were checked more frequently than nutrition facts (29%). Furthermore, there was a low level of dietary knowledge among consumers and a moderate level of believing food packages and media claims. CONCLUSIONS: Our results suggest that the Saudi community's understanding of food product information is limited and greater awareness and community education campaigns are required to improve the use of nutritional labels and increase nutritional knowledge.

Prevalence and Risk Factors of Self-Reported Perfume Sensitivity in Saudi Arabia.

Perfumes are widely used products; however, several fragrance substances used in perfuming are well-established allergenic substances and have been attributed to various adverse health reactions. The nature and significance of perfume sensitivity reactions have not been thoroughly investigated. Therefore, this study aimed to identify the prevalence, nature, and associated risk factors of self-reported perfume sensitivity among the general population in Saudi Arabia. A nationally representative cross-sectional study was conducted among adults in Saudi Arabia in October 2020. Significant associated risk factors were explored using multivariate regression analyses. A total of 1078 participants completed the survey, with a mean age of 36.7 years (SD ± 10.36). Perfume sensitivity reactions were reported in 14.6% of participants. From among these participants, 17.8% reported moderate to severe reactions. Respiratory and skin symptoms were the most reported reactions, with total rates of 40.1% and 35.7%, respectively. History of asthma (OR = 3.2, 95%CI 1.88-4.37, p < 0.001) and the use of counterfeit perfume products (OR = 1.9, 95%CI 1.23-2.94, p < 0.003) were significantly associated with a higher risk of perfume sensitivity. Our study revealed that a considerable number of the general population in Saudi Arabia has experienced adverse health reactions due to perfume products. The enormous volume of the perfume market thus necessitates further quantitative analysis studies to determine the presence of allergenic fragrance substances in perfumes.

SARS-CoV-2, surgeons and surgical masks.

The exact risk association of coronavirus disease 2019 (COVID-19) for surgeons is not quantified which may be affected by their risk of exposure and individual factors. The objective of this review is to quantify the risk of COVID-19 among surgeons, and explore whether facemask can minimise the risk of COVID-19 among surgeons. A systematised review was carried out by searching MEDLINE to locate items on severe acute respiratory syndrome coronavirus 2 or COVID-19 in relation to health care workers (HCWs) especially those work in surgical specialities including surgical nurses and intensivists. Additionally, systematic reviews that assessed the effectiveness of facemask against viral respiratory infections, including COVID-19, among HCWs were identified. Data from identified articles were abstracted, synthesised and summarised. Fourteen primary studies that provided data on severe acute respiratory syndrome coronavirus 2 infection or experience among surgeons and 11 systematic reviews that provided evidence of the effectiveness of facemask (and other personal protective equipment) were summarised. Although the risk of COVID-19 could not be quantified precisely among surgeons, about 14% of HCWs including surgeons had COVID-19, there could be variations depending on settings. Facemask was found to be somewhat protective against COVID-19, but the HCWs' compliance was highly variable ranging from zero to 100%. Echoing surgical societies' guidelines we continue to recommend facemask use among surgeons to prevent COVID-19.

The Impact of Receiving Pretravel Health Advice on the Prevention of Hajj-Related Illnesses Among Australian Pilgrims: Cohort Study.

BACKGROUND: Pretravel health advice can play a crucial role in improving both travelers' awareness about disease risk and compliance with preventive measures. General practitioners (GPs) and the internet have been reported internationally to be the main sources of health advice for travelers to non-mass gathering (MG) destinations. However, few studies have attempted to investigate the sources of health advice among travelers to MGs including the Hajj pilgrimage, and none of these studies further investigated the impact of pretravel advice on pilgrims' health behaviors. OBJECTIVE: The objective of this study was to investigate the impact of the source of pretravel health advice (from GPs and specialized Hajj travel agents) on Hajj pilgrims' awareness of and compliance with health recommendations, and the incidence of Hajj-associated illnesses. METHODS: A prospective cohort study (before and during Hajj) was conducted among Australian pilgrims aged ≥18 years in 2015. RESULTS: A total of 421 pilgrims participated prior to Hajj, and 391 (93%) provided follow-up data during Hajj. All participants obtained pretravel health advice from one or more sources, with Hajj travel agents (46%) and general practitioners (GPs; 40%) the most commonly reported sources. In total, 288 (74%) participants reported Hajj-related symptoms, of which 86% (248/288) were respiratory symptoms. Participants who obtained pretravel health advice from travel agents were more likely to be aware of the official Saudi recommendations (adjusted odds ratio [aOR] 2.1, 95% CI 1.2-3.8; P=.01), receive recommended vaccines before travel (aOR 2.4, 95% CI 1.4-3.9; P=.01), use hand sanitizers including soap (aOR 2.5, 95% CI 1.1-6.1; P=.03), and wash their hands after touching an ill person during Hajj (aOR 2.9, 95% CI 1.1-7.1; P=.01), compared to those who sought advice from GPs. However, neither advice from travel agents nor GPs was associated with a lower incidence of Hajj-related illnesses. CONCLUSIONS: Advice from travel agents appeared to be accessed by more travelers than that from GPs, and was associated with an increased likelihood of positive travel health behaviors.

National Cross-Sectional Study of Community-Based Adverse Drug Reactions in Saudi Arabia.

BACKGROUND: An adverse drug reaction (ADR) is a response to a medicine that is not intended and is harmful, and which occurs at normal dose levels for humans. Currently, there are no estimates of the population-based prevalence of ADRs in the Kingdom of Saudi Arabia (KSA). OBJECTIVE: The aims of this study were to (1) estimate the population-based prevalence of ADRs in KSA, (2) describe the ADRs experienced by survey respondents, and (3) investigate the level of awareness of the ADR reporting system. PATIENTS AND METHODS: This was a cross-sectional survey using stratified, population-based sampling conducted at a chain of community pharmacies. RESULTS: Analysis was conducted on 5228 surveys; 50.17% of respondents were males, and the mean age was 39 ± 15 years (min = 18, max = 98). The sample prevalence of ADRs was 23.45% (95% CI 22.30-24.60%, P < 0.001). The estimated population prevalence (after weighting) was 28.00% (26.10-30.00%). Gastrointestinal disorders were the most commonly reported ADRs (58.73%), followed by general disorders and administration site conditions (19.74%). The largest drug class that was reported to lead to ADRs was nonsteroidal anti-inflammatory drugs (NSAIDs) (11%). Over 19% of the respondents who experienced an ADR required medical intervention to control the suffering induced by the ADR. Of the respondents who experienced an ADR, 371 (30.26%) were aware of the ADR reporting system but only 53 (14.29%) said that they had filed a report in the system. CONCLUSIONS: Our study estimated that 28% of the population experienced an ADR over a 1-year period in KSA. Risk factors for ADR included certain chronic disease groups and the use of certain classes of medications. Regulatory authorities in KSA intend to conduct more research and deploy educational interventions to reduce ADR rates in KSA. This will hopefully occur in an international context that promotes the standardized measurement of ADRs in the community. A subset of findings from this report was presented in an oral presentation at the Saudi Food and Drug Authority (SFDA) Annual Conference, September 27, 2018. In addition, a subset of findings from this report were presented on a poster at the International Conference of Pharmacoepidemiology and Therapeutic Risk Management (ICPE), August 27, 2019.

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.

Hand Hygiene Compliance and Effectiveness Against Respiratory Infections Among Hajj Pilgrims: A Systematic Review.

The role of hand hygiene in the prevention of respiratory tract infections in Hajj pilgrims has not been assessed through a focussed systematic review of the literature. Considering this, a systematic review was undertaken to synthesize the up-to-date literature on the compliance and effectiveness of hand hygiene among Hajj attendees. Major databases, including OVID Medline, were searched by using a combination of MeSH terms and text words for potentially relevant articles. Data from identified articles were abstracted, quality assessed and combined into a summary effect. Twelve observational studies containing data of 6,320 pilgrims were included. The compliance of hand washing with non-alcoholic surfactants was 77.7% (ranged from 31.5% to 90.3% in individual studies) and the compliance of hand cleaning with alcoholic products was 44.9% (ranged from 30.7% to 67.4%). Education was a key influencer of hand hygiene practice. Only three of the six studies that assessed the effectiveness of hand hygiene against clinical disease found the practice to be effective, and only one of the two studies that evaluated its effectiveness against a laboratory-confirmed infection found it to be effective. This systematic review suggests that hand hygiene using non-alcoholic products is generally acceptable among Hajj pilgrims but there is no conclusive evidence on its effectiveness.

Effect on meningococcal serogroup W immunogenicity when Tdap was administered prior, concurrent or subsequent to the quadrivalent (ACWY) meningococcal CRM197-conjugate vaccine in adult Hajj pilgrims: A randomised controlled trial.

Immune responses to the capsular polysaccharide administered in the polysaccharide-protein conjugate vaccines can be either improved or suppressed by the pre-existence of immunity to the carrier protein. Receiving multiple vaccinations is essential for travellers such as Hajj pilgrims, and the use of conjugated vaccines is recommended. We studied the immune response to meningococcal serogroup W upon prior, concurrent and sequential administration of a quadrivalent meningococcal conjugate vaccine (MCV4) conjugated to CRM197 (coadministered with 13 valent pneumococcal vaccine conjugate CRM197 [PCV13]), and tetanus-diphtheria-acellular pertussis (Tdap) vaccine in Australian adults before attending the Hajj pilgrimage in 2014. Participants were randomly assigned, by computer-generated numbers, to three study arms by 1:1:1 ratio. Group A received Tdap followed by MCV4-CRM197 (+PCV13) 3-4 weeks later. Group B received all three vaccines in a single visit. Group C received MCV4-CRM197 (+PCV13) followed by Tdap 3-4 weeks later. Blood samples obtained prior to and 3-4 weeks after immunisation with MCV4-CRM197 were tested for meningococcal serogroup W-specific serum bactericidal antibody responses using baby rabbit complement (rSBA). One hundred and seven participants aged between 18 and 64 (median 40) years completed the study. No significant difference in meningococcal serogroup W rSBA geometric mean titre (GMT) was observed between the study arms post vaccination with MCV-CRM197 but Group A tended to have a slightly lower GMT (A = 404, B = 984 and C = 1235, p = 0.15). No statistical difference was noticed between the groups in proportions of subjects achieving a ≥4-fold rise in rSBA titres or achieving rSBA titre ≥8 post vaccination. In conclusion, receipt of MCV4-CRM197 vaccine prior, concurrent or subsequent to Tdap has similar immunologic response, and hence concurrent administration is both immunogenic and practical. However, further investigation into whether carrier induced suppression is a public health issue is suggested. Clinical trial registration: ANZCTR no. ACTRN12613000536763.

Exploring Australian Hajj Tour Operators' Knowledge and Practices Regarding Pilgrims' Health Risks: A Qualitative Study.

BACKGROUND: Travel agents are known to be one of the main sources of health information for pilgrims, and their advice is associated with positive health behaviors. OBJECTIVE: This study aimed to investigate travel agents' health knowledge, what health advice they provide to the pilgrims, and their sources of health information. METHODS: In-depth interviews were conducted among specialist Hajj travel agents in Sydney, Australia. Thematic analysis was undertaken. RESULTS: Of the 13 accredited Hajj travel agents, 9 (69%) were interviewed. A high level of awareness regarding gastrointestinal infections, standard hygiene methods, and the risk of injury was noted among the participants and was included in advice provided to pilgrims. However, very limited knowledge and provision of advice about the risk of respiratory infections was identified. Knowledge of the compulsory meningococcal vaccine was high, and all participated travel agents reported influenza vaccine (a recommended vaccine) as a second "compulsory" vaccine for Hajj visas. Conversely, participants reported very limited knowledge about other recommended vaccines for Hajj. The Ministry of Hajj website and personal Hajj experience were the main sources of information. CONCLUSIONS: This study identifies a potential path for novel health promotion strategies to improve health knowledge among Hajj travel agents and subsequently among Hajj pilgrims.

Saudi Hajj pilgrims' preparation and uptake of health preventive measures during Hajj 2017.

BACKGROUND: Few studies have reported the uptake of health preventive measures among Hajj pilgrims from Saudi Arabia. Yet, none of these studies have explored their perceptions of health risks at Hajj or pretravel health-advice-seeking behavior. METHODS: A cross-sectional survey conducted among Hajj pilgrims from Saudi Arabia. RESULTS: Of 344 pilgrims who completed the survey, 44% sought some form of pretravel health information; among them, 38% from non-medical sources. About 67% of participants received an influenza vaccine, and 8.7% received a pneumococcal vaccine. Lack of aware of vaccine availability was the main reason for nonreceipt (26%). Being employed and having a high level of education were significant factors in vaccine uptake. Two thirds of pilgrims carried some medications to use during Hajj; analgesics, antipyretics and antibiotics were the most reported drugs. Various methods of hand hygiene were the most used preventive measures (≈65%) followed by facemask use (53%). Those who concerned about food poisoning at Hajj were more likely to cleaned their hands with hand sanitizers (aOR = 2.5, 95% CI = 1.1-5.4, p = 0.01) and avoid eating food from street vendors (aOR = 2.9, 95% CI = 1.1-7.5, p = 0.02). CONCLUSION: Pretravel health-advice-seeking behavior and the use of preventive measures during Hajj were suboptimal among Saudi Hajj pilgrims.