Recording type 2 diabetes mellitus in a standardised central Saudi database: a retrospective validation study.

OBJECTIVES: This study was conducted to assess the validity of recording (and the original diagnostic practice) of type 2 diabetes mellitus at a hospital whose records were integrated to a centralised database (the standardised common data model (CDM) of the Saudi National Pharmacoepidemiologic Database (NPED)). DESIGN: A retrospective single-centre validation study. SETTINGS: Data of the study participants were extracted from the CDM of the NPED (only records of one tertiary care hospital were integrated at the time of the study) between 1 January 2013 and 1 July 2018. PARTICIPANTS: A random sample of patients with type 2 diabetes mellitus (≥18 years old and with a code of type 2 diabetes mellitus) matched with a control group (patients without diabetes) based on age and sex. OUTCOME MEASURES: The standardised coding of type 2 diabetes in the CDM was validated by comparing the presence of diabetes in the CDM versus the original electronic records at the hospital, the recording in paper-based medical records, and the physician re-assessment of diabetes in the included cases and controls, respectively. Sensitivity, specificity, positive predictive value and negative predictive value were estimated for each pairwise comparison using RStudio V.1.4.1103. RESULTS: A total of 437 random sample of patients with type 2 diabetes mellitus was identified and matched with 437 controls. Only 190 of 437 (43.0%) had paper-based medical records. All estimates were above 90% except for sensitivity and specificity of CDM versus paper-based records (54%; 95% CI 47% to 61% and 68%; 95% CI 62% to 73%, respectively). CONCLUSIONS: This study provided an assessment to the extent of which only type 2 diabetes mellitus code can be used to identify patients with this disease at a Saudi centralised database. A future multi-centre study would help adding more emphasis to the study findings.

Antimicrobial Sales Comparison before and after the Implementation of Nationwide Restriction Policy in Saudi Arabia.

Antimicrobial dispensing without a prescription has been identified as a significant contributor to the burgeoning crisis of antimicrobial resistance. To combat this, the Saudi Ministry of Health introduced a stringent antimicrobial restriction policy in mid-2018, mandating prescriptions for all antimicrobial drug dispensations at pharmacies. Therefore, this study aimed to assess the immediate impact of this policy on retail antimicrobial sales. To do so, we analyzed annual sales data from 2017 to 2019 sourced from the IQVIA-MIDAS® database, which included a range of antimicrobials, such as antibiotics, antifungals, and other related agents. The analysis revealed a notable reduction in overall antimicrobial sales by 23.2%, decreasing from 818.9 million SAR in 2017 to 648.4 million SAR in 2019. While the Wilcoxon signed-rank test indicated a statistically significant median reduction in total antimicrobial sales post-policy implementation (p = 0.0397), it is important to acknowledge that the long-term effects and adherence to the policy require further investigation. Notably, sales of amoxicillin dropped by 70% in 2019 compared to 2017, contributing largely to the decline. Conversely, a continuous increase in sales of some antimicrobial drugs following the restriction policy was observed, led by amoxicillin/clavulanic acid. Our data support the implementation of antimicrobial restriction measures as an effective means of controlling excessive antimicrobial sales and dispensing without prescriptions.

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.

The impact of regulatory restrictions on pregabalin use in Saudi Arabia: An interrupted time series analysis.

PURPOSE: The Saudi Food and Drug Authority (SFDA) added pregabalin to the list of controlled substances in December 2017 to minimize the risk of its possible abuse and misuse. This study was aimed at assessing the impact of this decision on the overall use of pregabalin in Saudi Arabia and in comparison with drugs prescribed to treat neuropathic pain (i.e., vs. gabapentin, tramadol, duloxetine, and amitriptyline). METHODS: This was an interrupted time-series analysis of the Saudi quarterly sale data of the study drugs from October/2015 to September/2020. These data were obtained from IQVIA and were converted into use estimates (defined daily dose per 1000 inhabitant-days [DDD/TID]). Segmented regression models were conducted to assess the direct (level) and prolonged (trend) changes in use data after the decision. All analyses were completed using RStudio Version 1.4.1103. RESULTS: Before the SFDA's decision, there was an increased quarter-to-quarter use of pregabalin (DDD/TID: 0.16; 95% confidence interval [CI] 0.04 to 0.28). Pregabalin overall use dropped sharply by -1.85 DDD/TID (95% CI -2.71 to -0.99) directly after the decision with a prolonged quarter-to-quarter declining effect (DDD/TID: -0.22, CI to -0.37 to -0.05). The decision was associated with a direct increase in the use of gabapentin by 0.62 DDD/TID (95% CI 0.52-0.72) without any impact on the use of other drugs. CONCLUSIONS: The results of our study showed that the SFDA decision was associated with a decrease in the overall use of pregabalin, which may help minimize the risk of its abuse and misuse.

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.

Public Response, Anxiety and Behaviour during the First Wave of COVID-19 Pandemic in Saudi Arabia.

This study aims to investigate public response attitude, anxiety, practices and trust in the authorities' mitigation plan during the first wave of COVID-19 pandemic. A national cross sectional phone survey was conducted among Saudi residents aged 16 years and above. A total of 90,421 (45.2%) individuals participated in the study. Of those, the overall rate of COVID-19 correct knowledge was 82% (mean: 9.84); social media was the most reported source of knowledge. Younger age, low levels of education and foreign residents were associated with poor knowledge. Overall, 49.5% scored 5 or more on the GAD-7 test, indicating anxiety symptoms, 19.2% of them scored 10 and above, suggesting moderate to severe anxiety. Majority of participants (>78%) trusted and supported the interventions implemented by the government to control COVID-19. Social distancing practices among participants was as following, 72.5% stayed at home and avoid going out for nonessential business and 49.5% avoided attending social events and family gatherings. Trust in authorities, being anxious, worry and levels of knowledge about the disease, were the most common factors affecting adoption of the recommended practices. Continuous evaluation of public response about COVID-19, and the effectiveness of protective measures is essential to better inform policy-makers and identify ways of encouraging behaviour change among public during pandemic.