Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.

Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors onsite, ensuring efficient utilization of resources and the efficiency of inspection process. The objective of this research is to examine and document the shared encounters involving remote inspections and evaluations carried out by SFDA from 2020 to 2022. This will be achieved through the evaluation of the accuracy of document evaluation and the extent to which the objectives of smart GxP inspections were met. Data were collected from local and international smart inspections reports conducted by SFDA between 2020 and 2022, covering medical device manufacturers, pharmaceutical manufacturing sites, warehouses, accreditation offices, scientific offices, and food manufacturing facilities. The results indicate that smart GxP inspections were effective in achieving visit objectives, showing a high degree of document evaluation accuracy. The findings of this study support the use of smart GxP inspections as a valuable alternative to on-site inspections, offering a practical solution to regulatory compliance during the pandemic and beyond. Although the SFDA recognizes the usefulness of smart inspections in upholding regulatory oversight in the face of various challenges, it does not endorse the complete replacement of conventional on-site inspection methods. The SFDA acknowledges significant limitations associated with the current technological resources used in remote regulatory assessments, and these limitations will be explored in the relevant sections.

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.

Using Phages to Reduce Salmonella Prevalence in Chicken Meat: A Systematic Review.

Salmonellosis is an infection that significantly impacts chicken and humans who consume it; it is a burden on public health and a contributor to commercial losses in the chicken industry worldwide. To tackle chicken meat-related bacterial infections, significant quantities of antibiotics alongside several infection prevention measures are used worldwide. However, chemical additives, such as organic acids, and chlorine-based interventions all have different limitations. These include feed refusal due to a change of taste, and incompatibility between organic acids and other inoculated preservative agents such as antimicrobial agents. Phages are host-specific viruses that interact with bacteria in a specific manner. Therefore, they possess unique biological and therapeutic features that can be used to reduce bacterial contamination, leading to improved food safety and quality. This systematic review examines the current evidence regarding the effectiveness of various phages on Salmonella colonization in chicken meat. This review summarizes findings from 17 studies that were conducted in vitro with similar experimental conditions (temperature and incubation parameters) to test the efficacy of isolated and commercially available phages on chicken raw meat samples. The current evidence suggests that most of the in vitro studies that used phages as a biocontrol to eradicate Salmonella contamination in chicken meat were successful. This indicates that phages constitute a promising solution worldwide for tackling foodborne bacteria, including Salmonella.

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 Risk of Community-Acquired Enteric Infection in Proton Pump Inhibitor Therapy: Systematic Review and Meta-analysis.

BACKGROUND: Previous meta-analyses suggest that users of proton pump inhibitors (PPIs) have a higher risk of developing enteric infections compared with nonusers. These previous meta-analyses have considerable heterogeneity, and it is not clear whether the effect of PPIs is different for different types of microorganisms. OBJECTIVE: The aim of this study is to update previous meta-analyses, concentrating on enteric infection in community settings and exploring potential sources of heterogeneity. METHODS: A systematic search was conducted on electronic databases (all available years until November 2017). PubMed, EMBASE, Cochrane, and Web of Science were searched using specific keywords related to PPI therapy and community-acquired enteric infection. Eligible studies were selected based on prespecified criteria. RESULTS: A total of 9 observational studies evaluating community-acquired enteric infection were eligible, including 12 separate analyses. The meta-analysis showed that PPI users have an increased risk of developing community-acquired enteric infection (pooled odds ratio [OR] = 4.28; 95% CI = 3.01-6.08). There was significant heterogeneity between the studies ( I2 = 85%; P < 0.001), which was partly explained by type of microorganism. The strength of the association was similar for Salmonella (pooled OR = 4.84; 95% CI = 2.75-8.54; I2 = 58.7%; P = 0.064) and Campylobacter (pooled OR = 5.09; 95% CI = 3-8.64; I2 = 81%; P < 0.001) but lower for studies that combined all bacteria (pooled OR = 2.42; 95% CI = 0.96-6.14; I2 = 94.3%; P < 0.001). CONCLUSION: PPI users have an increased risk of developing community-acquired enteric infections compared with nonusers. The heterogeneity was partially explained by type of microorganism; the association is stronger for Salmonella and Campylobacter than for all bacteria combined.

A systematic review of human-to-human transmission of measles vaccine virus.

Measles is one of the most contagious human diseases. Administration of the live attenuated measles vaccine has substantially reduced childhood mortality and morbidity since its licensure in 1963. The live but attenuated form of the vaccine describes a virus poorly adapted to replicating in human tissue, but with a replication yield sufficient to elicit an immune response for long-term protection. Given the high transmissibility of the wild-type virus and that transmission of other live vaccine viruses has been documented, we conducted a systematic review to establish if there is any evidence of human-to-human transmission of the live attenuated measles vaccine virus. We reviewed 773 articles for genotypic confirmation of a vaccine virus transmitted from a recently vaccinated individual to a susceptible close contact. No evidence of human-to-human transmission of the measles vaccine virus has been reported amongst the thousands of clinical samples genotyped during outbreaks or endemic transmission and individual case studies worldwide.