Overview of online pharmacy regulations in Saudi Arabia and the Gulf cooperation council countries and their impact on online pharmacy service providers in Saudi Arabia: a qualitative analysis

BackgroundLaws and regulations are needed to regulate the growing online pharmacy (OP) services. The main objective of this work was to provide an overview of the laws and regulations for OP services in the Gulf Cooperation Council (GCC) countries. In addition, the perception of how these laws and regulations in Saudi Arabia (SA) affect the online ordering of medications and health-related products from national and international OPs was explored.MethodsA secondary data collection through emails and a qualitative descriptive analysis was used to gain insight into the OP regulations in the GCC countries. Then, a qualitative study was carried out with semi-structured interviews to investigate the impact of these regulations on the practice and the market from the OP service providers’ perspective. The interviews were carried out with a sample of major OP service providers in SA, to represent the GCC countries. During the interviews, multiple open-ended questions were used to explore opinions about the OP regulations and how these regulations affected the practice. The interviews were then transcribed and thematically analysed.ResultsResponses were mainly received from regulators in SA, Bahrain, Oman and United Arab Emirates (UAE). SA and UAE allow for offering of OP services as add-on service for existing community pharmacy, while UAE also allows for standalone OP providers. SA, Bahrain, and Oman allow online ordering of both over-the-counter (OTC) and prescription-only medications (POM) from international OP; a prescription is required for POM and quantities allowed should be no more than 3 months’ supply in case of SA and Oman while this was not specified in case of Bahrain. Invoice of purchase was also required for any POM to be released from customs in SA and Bahrain but not in Oman and UAE. Controlled medications were prohibited to be ordered online in SA, UAE, and Bahrain while it was allowed in Oman if the prescription was issued within 6-month, and the quantity dispensed was for 1 month only. Apart from online ordering of medications in these countries, no specific regulations existed to regulate ordering of other health-related products from local or international OPs. Whether Kwait and Qatar have regulations for OP could not be established due to lack of response. Two of the four interviewed representatives of OP service providers in SA were not aware of the existence of specific regulations for OP services. The representatives who were aware of these regulations were satisfied with them and found them beneficial for their business and for the patients at the same time. However, representatives raised concerns regarding the enforcement of regulations on international OP providers.ConclusionThe existing regulations for online ordering of medications are somewhat comparable between the GCC countries, with no specific regulations for ordering of other health-related products from local or international OPs. In SA, there is limited awareness of the existing regulations for OP services by providers. Nevertheless, the need for detailed regulations on certain aspects of OP services was highlighted, such as regulations for international OPs and importing medications for personal use

Whole-genome sequencing reveals host factors underlying critical COVID-19

Critical COVID-19 is caused by immune-mediated inflammatory lung injury. Host genetic variation influences the development of illness requiring critical care1 or hospitalization2–4 after infection with SARS-CoV-2. The GenOMICC (Genetics of Mortality in Critical Care) study enables the comparison of genomes from individuals who are critically ill with those of population controls to find underlying disease mechanisms. Here we use whole-genome sequencing in 7,491 critically ill individuals compared with 48,400 controls to discover and replicate 23 independent variants that significantly predispose to critical COVID-19. We identify 16 new independent associations, including variants within genes that are involved in interferon signalling (IL10RB and PLSCR1), leucocyte differentiation (BCL11A) and blood-type antigen secretor status (FUT2). Using transcriptome-wide association and colocalization to infer the effect of gene expression on disease severity, we find evidence that implicates multiple genes—including reduced expression of a membrane flippase (ATP11A), and increased expression of a mucin (MUC1)—in critical disease. Mendelian randomization provides evidence in support of causal roles for myeloid cell adhesion molecules (SELE, ICAM5 and CD209) and the coagulation factor F8, all of which are potentially druggable targets. Our results are broadly consistent with a multi-component model of COVID-19 pathophysiology, in which at least two distinct mechanisms can predispose to life-threatening disease: failure to control viral replication; or an enhanced tendency towards pulmonary inflammation and intravascular coagulation. We show that comparison between cases of critical illness and population controls is highly efficient for the detection of therapeutically relevant mechanisms of disease

Whole-genome sequencing reveals host factors underlying critical COVID-19

Critical COVID-19 is caused by immune-mediated inflammatory lung injury. Host genetic variation influences the development of illness requiring critical care1 or hospitalization2,3,4 after infection with SARS-CoV-2. The GenOMICC (Genetics of Mortality in Critical Care) study enables the comparison of genomes from individuals who are critically ill with those of population controls to find underlying disease mechanisms. Here we use whole-genome sequencing in 7,491 critically ill individuals compared with 48,400 controls to discover and replicate 23 independent variants that significantly predispose to critical COVID-19. We identify 16 new independent associations, including variants within genes that are involved in interferon signalling (IL10RB and PLSCR1), leucocyte differentiation (BCL11A) and blood-type antigen secretor status (FUT2). Using transcriptome-wide association and colocalization to infer the effect of gene expression on disease severity, we find evidence that implicates multiple genes—including reduced expression of a membrane flippase (ATP11A), and increased expression of a mucin (MUC1)—in critical disease. Mendelian randomization provides evidence in support of causal roles for myeloid cell adhesion molecules (SELE, ICAM5 and CD209) and the coagulation factor F8, all of which are potentially druggable targets. Our results are broadly consistent with a multi-component model of COVID-19 pathophysiology, in which at least two distinct mechanisms can predispose to life-threatening disease: failure to control viral replication; or an enhanced tendency towards pulmonary inflammation and intravascular coagulation. We show that comparison between cases of critical illness and population controls is highly efficient for the detection of therapeutically relevant mechanisms of disease

Comparative Effectiveness of Venous Thromboembolism (VTE) Prophylaxis in Patients with Cancer

Objective: To evaluate the safety and effectiveness of anticoagulants used for thromboprophylaxis in cancer patients Background: Cancer patients account for 20% of all VTE cases in the United States, and VTE has a more substantial effect on cancer patients than on non-cancer patients. Despite many clinical practice guidelines, the anticoagulant’s effectiveness still remains controversial in cancer patients. Methods: A retrospective comparative effectiveness cohort study was conducted using data from the Medical Expenditure Panel Survey. The incidence of VTE, bleeding, and all-cause death events; and health-related quality of life were used as outcomes to evaluate the two cohorts (prophylactic and matching-control). The effects of age, gender, race, and comorbidities on the clinical outcomes were controlled in logistic regression. Results: The incidence of VTE was higher in the prophylactic cohort than the matching-control (5.6% vs. 2.1%, respectively, with a relative risk (RR) of 2.66, 95%CI 2.64-2.68). Furthermore, there were more bleeding (29% vs. 24%, RR 1.21, 95%CI 1.21-1.22) and all-cause death events (10.13% vs. 6.86%, RR 1.47, 95%CI 1.46-1.48) in the prophylactic cohort than in the matching-control cohort. However, after controlling for the effect of age, gender, race, and comorbidities these differences between the two cohorts became statistically insignificant. The use of thromboprophylaxis was associated with a significant decline in physical quality of life, with no significant impact on mental quality of life. Conclusion: The present study findings support the current guidelines’ recommendation pertaining to VTE prophylaxis in cancer patients by providing evidence on the anticoagulants’ effectiveness for thromboprophylaxis in real-world practice

Predictors of Poor Outcome among Critically Ill COVID-19 Patients: A Nationally Representative Sample of the Saudi Arabian Population

The outbreak and continuing impact of COVID-19 have significantly increased the rates of hospitalization and admissions to intensive care units (ICU). This study evaluates clinical outcomes in critically ill patients and investigates variables tied to poor prognosis. A secondary database analysis was conducted to investigate the predictors of poor outcome among critically ill COVID-19 patients in Saudi Arabia. Multivariable logistic regression analysis was used to assess the association between various demographic characteristics, comorbidities, and COVID-19 symptoms and patients’ poor prognosis, as a composite outcome. A total of 2257 critically ill patients were identified (male (71.8%), and elderly (37.3%)). The mortality rate was 50.0%, and the composite poor outcome was 68.4%. The predictors of poor outcome were being elderly (OR = 4.79, 95%CI 3.19–7.18), obesity (OR = 1.43, 95%CI 1.1–1.87), having a severe or critical case at admission (OR = 6.46, 95%CI 2.34–17.8; OR = 22.3, 95%CI 11.0–45, respectively), and some signs and symptoms of COVID-19 such as shortness of breath, feeling fatigued or headache, respiratory rate ≥ 30/min, PaO2/FiO2 ratio < 300, and altered consciousness. In conclusion, identifying high-risk populations that are expected to have a poor prognosis based on their criteria upon admission helps policymakers and practitioners better triage patients when faced with limited healthcare resources

Clinical pharmacists’ knowledge, attitude, perception, and beliefs about the role of pharmacogenetic testing for genes polymorphisms when prescribing mercaptopurine

Background: Single nucleotide polymorphisms in the gene encoding proteins involved in mercaptopurine metabolism can influence drug efficacy and safety. This study aims to assess clinical pharmacists’ knowledge about mercaptopurine-related genes and their polymorphisms and investigate their attitudes, perceptions, and beliefs about the need for and importance of pharmacogenetic testing for mercaptopurine. Methods: A cross-sectional descriptive study was conducted among oncology/hematology clinical pharmacists in Saudi Arabia using an online-questionnaire developed by experts in the field. The questionnaire consists of four-sections exploring clinical pharmacists’ knowledge, attitudes, perceptions, and beliefs about the importance of gene testing and genes polymorphism when prescribing mercaptopurine. Descriptive statistics were used to analyze the data in the study. Results: A total of 41 oncology/hematology clinical pharmacists responded to the survey invitation. Almost half of them had more than 10 years of work experience, but only 17 % of them received formal training in pharmacogenetics. The overall level of knowledge about pharmacogenetics among participants was low, with a mean score of 2.8 points (1.7) out of 8 items. However, around 76 % agreed that it is important to perform pharmacogenetic screening prior to prescribing mercaptopurine, and almost 93 % state that it will influence their dosage recommendation. Most of the participants had a good perception (95.1 %) of their role in genetic testing for medication selection, dosing, and monitoring; however, about 10 % of surveyed pharmacists reported not being completely responsible about recommending pharmacogenetic testing. The surveyed pharmacists had a good belief in the importance of pharmacogenetic testing and their overall attitude was positive toward the use of pharmacogenetic testing, with emphasis on the importance of training on the proper assessment and interpretation of pharmacogenetic tests. Conclusions: Pharmacists demonstrated good perception and positive attitude toward pharmacogenetic testing, despite the low level of knowledge and limited formal training. Thus, more attention to developing national guidelines on pharmacogenetic testing is warranted to ensure successful pharmacogenetic testing implementation

Trends of Cancer-Associated Venous Thromboembolism (VTE) In the United States (2005-2014)

Introduction Cancer patients are prone to higher risk of venous thromboembolism (VTE) compared to the general population. However, the estimated incidence of cancer-associated VTE varied among the studies. The primary objective of this study was to determine the national annual incidence and examine the trend of cancer-associated VTE in the US over the years from 2005 to 2014. Methods A retrospective population based study was conducted using data from the Medical Expenditure Panel Survey. The study included all noninstitutionalized US adults aged ≥18 years who had a final person-weight \u3e 0 to be representative of the national population. Simple linear regression (SLR) and Mann-Kendall (MK) tests were used to examine the trend of cancer-associated VTE over the years. Results On average, there were 15,570,000 adult persons living with a cancer condition every year. Female represented 53.8% of the study population, and the mean of age was 63.5 years. The overall annual incidence of cancer-associated VTE varied between 1.80 and 0.72% over the years, with an overall average of 1.18%. The study found a non-significant downward trend in the incidence of cancer-associated VTE over the years. Patients who had cancer-associated VTE were significantly older than patients without VTE (mean 68.64 vs. 62.68 years, p \u3c .0001). Conclusion The study found cancer patients continued to have the risk of VTE over the years. The non-significant downward trend in cancer-associated VTE suggests that health care practitioners are heading in the right direction, but enhanced preventative care is needed to avoid further incidents of cancer-associated VTE

The prevalence of cardiovascular diseases, chronic kidney disease, and obesity in patients with type 2 diabetes mellitus and the description of concurrent treatments: A two-center retrospective cross-sectional study in Saudi Arabia

Background: Atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), chronic kidney disease (CKD), and obesity are associated with increased morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Nonetheless, their prevalence among patients with T2DM in Saudi Arabia (SA) remains unknown. As current guidelines recommend, these comorbidities require adding certain antidiabetic agents with cardiorenal benefits. However, the prescribers' adherence to these recommendations remains unclear. Methods: A two-center retrospective cross-sectional study was conducted including adult patients (≥18 years) with T2DM admitted to hospital or seen at outpatient clinics between January and December 2020. Patients were classified into two groups based on the presence or absence of ASCVD. Patients with no prior ASCVD history were further classified based on the 10-year ASCVD risk estimation. Endpoints of interest included the prevalence of ASCVD, HF, CKD, and obesity in patients with T2DM. We also evaluated the characteristics of the utilized antidiabetic agents, statin, and aspirin therapies.. Results: Of the 1,218 included patients with T2DM, the majority were female (57.0 %), and aged 45–64 years (53.0 %) with a mean age of 59.3 ± 13.1 years. Hypertension and dyslipidemia were the most prevalent comorbidities (67.7 % and 69.0 %, respectively). Among all patients, 18.6 % had an established ASCVD and the prevalence of HF, CKD, and obesity were 5.1 %, 8.7 %, and 58.3 %, respectively. The most common types of ASCVD witnessed were revascularization (42.3 %), myocardial infarction (36.6 %), and stroke (33.9 %); with an increased prevalence of ASCVD as the age increases (52.8 % at age ≥ 65 years). In the non‐ASCVD group, the 10-year ASCVD risk was intermediate or high in 62.7 % of these patients. The rates of utilization of guidelines-recommended therapies were 83.6 % for metformin, 9.4 % for GLP-1 RA, 10.8 % for SGLT2i, 35.2 % for aspirin alone or in combination with clopidogrel, and 79.7 % for statin therapy. Conclusions: ASCVD, HF, CKD, and obesity are common complications in patients with T2DM in SA, with low overall utilization of the recommended guidelines-recommended medical therapies. Multimodal strategies should be utilized to assess T2DM and its complications, and to improve prescribers' adherence to guidelines-recommended therapies