The Characteristics of Clinical Studies Submitted to the Saudi Food and Drug Authority from 2009 until 2020.

BACKGROUND: Clinical trials are crucial in contemporary evidence-based medicine for discovering new treatments for diseases. Their registration in a registry increases the transparency in the dissemination of knowledge about clinical research. It is essential to understand the activity of clinical trials in a country, thus identifying research gaps. OBJECTIVE: This study, therefore, aims to describe the clinical trial activity since the inception of clinical trials' administration and national clinical trials' registry within the Kingdom of Saudi Arabia (KSA). METHOD: A descriptive study was conducted by reviewing all clinical studies that have been registered during 2009 and June 2020. The inclusion criterion was all phases of the clinical trials registered in the national registry during that period. Data analysis was done using descriptive statistics. RESULTS: Since 2009, 352 studies have been registered. However, a total of 333 studies with complete data was included in the analysis. A total of 80 sponsors funded the clinical studies in the KSA. The majority of the clinical studies are funded by multinational pharmaceutical companies. Oncology (13.81%) and diabetes (11.71%) were the most common therapeutic areas and constituted the largest proportion of the overall studies. 44% were phase 4 and 40% were phase 3 studies. CONCLUSION: With a population approaching 34 million, the number of clinical trials in the KSA is not sufficient. Since the inception of the clinical trial's administration and SCTR, the emphasis has been on phase 3 and phase 4 clinical studies. The most studied therapeutic areas were oncology and diabetes. Many clinical studies in the KSA were sponsored by multinational pharmaceutical companies.

Prescribing errors and associated factors in discharge prescriptions in the emergency department: A prospective cross-sectional study.

OBJECTIVES: Evidence regarding the prevalence of medication prescribing errors (PEs) and potential factors that increase PEs among patients treated in the emergency department (ED) are limited. This study aimed to explore the prevalence and nature of PEs in discharge prescriptions in the ED and identify potential risk factors associated with PEs. METHODS: This was a prospective observational cross-sectional study in an ambulatory ED in a tertiary teaching hospital. Data were collected for six months using a customized reporting tool. All patients discharged from ED with a discharged prescription within the study period were enrolled in this study. RESULTS: About 13.5% (n = 68) of the 504 prescriptions reviewed (for 504 patients) had at least one error. Main PEs encountered were wrong dose (23.2%), wrong frequency (20.7%), and wrong strength errors (14.6%). About 36.8% of identified PEs were related to pediatric prescriptions, followed by the acute care emergency unit (26.5%) and the triage emergency unit (20.6%). The main leading human-related causes associated with PEs were lack of knowledge (40.9%) followed by an improper selection from a computer operator list (31.8%). The leading contributing systems related factors were pre-printed medication orders (50%), lack of training (31.5%), noise level (13.0%), and frequent interruption of prescriber and distraction (11.1%). Prescribers' involved with the identified errors were resident physicians (39.4%), specialists (30.3%), and (24.4%) were made by general practitioners. Physicians rejected around 12% of the pharmacist-raised recommendations related to the identified PEs as per their clinical judgment. CONCLUSION: PEs in ED setting are common, and multiple human and systems-related factors may contribute to the development of PEs. Further training to residents and proper communication between the healthcare professionals may reduce the risk of PEs in ED.

Prevalence and Factors Associated With Polypharmacy Use Among Adult Patients in Saudi Arabia.

BACKGROUND: Polypharmacy is very common in clinical practice, especially among adult patients. The use of multiple medications may increase the risk of adverse drug events, medication cost, and medication errors. In addition, polypharmacy exacerbates treatment complexity, which consequently leads to poor patients' adherence to their medications. Despite being a well-recognized problem, few studies have investigated the prevalence and predictors of polypharmacy in Saudi Arabia. OBJECTIVES: The aims of the study were to investigate the prevalence of polypharmacy among adult patients in a tertiary teaching hospital and to determine patients' characteristics that are associated with polypharmacy. METHODS: This was a retrospective cross-sectional study using data extracted from the electronic health records database for a period of 6 months between January and June 2016 in outpatient setting. Descriptive statistics were used to analyze the study sample. A multivariate logistic regression model was used to examine the association between different variables and polypharmacy. Statistical analysis software (SAS 9.2) was used to analyze the study data. RESULTS: A total of 17,237 observations (67.2% females) were included in the final analysis. Of these, nearly 54% (n = 9222) of reported observations were found using up to four prescription drugs and the other 46% (n = 8015) were using five or more prescription drugs. Interestingly, the prevalence of polypharmacy use was doubled among adults with hypertension as compared with those without hypertension (odds ratio [OR] = 2.68, 95% confidence interval [CI] = 2.51-2.87). In addition, polypharmacy use was two times more prevalent among adults with diabetes as compared with those without diabetes (OR = 2.31, 95% CI = 1.99-2.28) and five times more prevalent in patient with dementia (OR = 5.57, 95% CI = 1.26-24.7). Moreover, polypharmacy in adult patients was significantly influenced by sex (OR = 1.69, 95% CI = 1.59-1.80) and nationality (OR = 2.15, 95% CI = 2.00-2.31). CONCLUSIONS: Polypharmacy is common among adult patients especially those who are older than 60 years. Polypharmacy may affect the overall process of drug therapy. It can be a risk factor to develop undesirable adverse drug events, especially in those with chronic health conditions. A special care should be taken to manage polypharmacy among adults in Saudi Arabia.

COVID-19 impact on pharmacy education in Saudi Arabia: Challenges and opportunities.

The first case of COVID-19 was announced at the end of year 2019, and later many cases were identified worldwide. In Saudi Arabia, the first case was announced on 2 March 2020. To prevent the spread of this pandemic disease, many precautionary actions were taken by Saudi government. One of these actions was closing public and private schools and universities and transfer the educational activities to virtual platforms. All colleges of Pharmacy in Saudi Arabia, whether the 21 public or the eight private ones, were affected by those sudden transitions and their responses varied according to their preparedness levels. Here we shared our experience in king Saud University in the curricular components of pharmacy school that includes classroom teaching, laboratory teaching, experiential training, assessment, and extracurricular activity and student support during COVID-19 compulsory lockdown. Lastly, we presented the lesson learned toward pharmacy education from COVID-19 pandemic.

The Utilization of Complementary and Alternative Medicine among Saudi Older Adults: A Population-Based Study.

BACKGROUND: Complementary and alternative medicine (CAM) is an integral part of patients' therapeutic experience worldwide. Among Saudi older adults, less is known about CAM utilization. OBJECTIVES: To determine the prevalence, patterns, and factors associated with CAM utilization among SOA. METHODS: In the Saudi National Survey for Elderly Health (SNSEH), subjects were asked about CAM use during the last twelve months before the interview. CAM use was defined as any use of herbal products, acupuncture, bloodletting, cauterization, medical massage, bones manual manipulation, honey, or religious rituals. Demographic characteristics included gender, age, marital status, region, educational level, and residence area. In addition, multiple comorbidities were included as possible factors that may be associated with CAM use. Multivariable logistic regression was used to explore factors associated with CAM utilization. All statistical analyses were done using STATA v.14. RESULTS: Out of 2946 respondents, 50.4% were males, the mean age was 70.3 ± 8.3 years, and 70% were illiterate. CAM use was prevalent (62.5%). The most common CAM types were herbal products (25.4%), acupuncture (21.2%), bloodletting (12%), honey (9.5%), cauterization (7.4%), medical massage and bones manual manipulation (4%), and traditional bone setting (2.1%). In the multivariable regression, age, gender, and marital status did not have an impact on the odds of using CAM. Subjects from rural areas were 2.92 times more likely to use CAM compared with subjects in urban areas (OR = 2.92; 95%CI: 2.28-3.75). Subjects with metabolic disorders (OR = 0.50; 95% CI: 0.42-0.60) or kidney disease were less likely to use CAM (OR = 0.30; 95%CI: 0.14-0.64). About pain, CAM is used more in neck pain (OR = 1.69; 95%CI: 1.30-2.21) and also used in back pain (OR = 1.22; 95%CI: 1.03-1.46). CONCLUSIONS: CAM use was very prevalent among SOA. Clinicians and pharmacists must ask about CAM use among older adults as many of CAM may interact with patients medications.

Prevalence and Incidence of Dementia in People with Diabetes Mellitus.

BACKGROUND: Few studies have shown that an increased risk of dementia is associated with diabetes mellitus. OBJECTIVE: To estimate the prevalence and incidence of dementia in people with diabetes in primary care in the UK. METHODS: We conducted a descriptive study using the UK The Health Improvement Network (THIN) database. People diagnosed with diabetes from 2000 to 2016 were included in the study. Prevalence and incidence rates of dementia were calculated annually, stratified by age and gender. RESULTS: The prevalence of dementia was 0.424% [95% CI (0.420%-0.427%)] in 2000 and 2.508% [95% CI (2.501%-2.515%)] in 2016. The highest prevalence was in those aged 85+ from 2.9% [95% CI (2.890%-2.974%)] in 2000 to 11.3% [95% CI (11.285%-11.384%)] in 2016. The incidence of dementia increased 3.7 times, from 0.181 cases per 100 persons [95% CI (0.179-0.183)] in 2000 to 0.683 cases per 100 persons [95% CI (0.679-0.686)] in 2016, respectively. Women had a higher prevalence and incidence of dementia than men 3.138% [95% CI (3.127%-3.150%)] versus 2.014% [95% CI (2.006%-2.022%)] and 0.820 [95% CI (0.814-0.826)] versus 0.576 cases per 100 persons [95% CI (0.571-0.580)] in 2016, respectively. CONCLUSION: There was a trend of increasing prevalence and incidence of dementia in people with diabetes over the period of 2000 to 2016. This study adds to the evidence on dementia prevalence and incidence, particularly in the diabetic population.

Pharmacy students' satisfaction with Introductory Pharmacy Practice Experiences (IPPE) at community pharmacy: The case of Saudi Arabia.

OBJECTIVE: To assess pharmacy students' satisfaction with introductory pharmacy practice experiences (IPPE) at community pharmacy and the impact of the training on their future career. METHODS: A self-administered questionnaire was made available to 74 male pharmacy students who completed 4 weeks community pharmacy IPPE. The questionnaire consists of 24 questions that were organized into 5 domains with a scale of six options were used to answer each question. RESULTS: A total of 43 students completed the survey (58%). Most of them evaluated their training experience as either as good (41.86%) or excellent (41.86%). One third of students (34.88%) were very satisfied about the clarity of the community pharmacy IPPE goals and objectives given prior to the training period. About half of students (51.6%) received a good direction and feedback from their preceptors. Regarding the contact with the patient or guardian, (39.53%) of the students chose neutral while (25.58%) of the students were very satisfied. The learning environment was satisfactory for (32.56%) of students. Regarding skills domain, students strongly agreed that their skills were improved; Communication skills as reported by (48.84%) of students, documentation skills as reported by (34.88%) of students, and clinical skills as reported by (34.88%) of students. CONCLUSION: Surveyed male students were in general satisfied with their training experience at community pharmacy. Providing an orientation to the community pharmacy preceptors and granted electronic access of necessary information to the students might increase their satisfaction.

The impact of diabetes mellitus on health-related quality of life in Saudi Arabia.

OBJECTIVE: To evaluate the effect of different demographic, clinical and social factors on diabetic patients' quality of life (QOL). RESEARCH DESIGN AND METHODS: A cross sectional study conducted on patients with type 2 diabetes who attended King Abdulaziz University Hospital outpatient clinics between February and March 2017. The patients were asked about sociodemographic data including age, sex, educational level, exercise history and marital status in addition to clinical data such as duration of diabetes, presence of comorbidities as well as medication history. The patients' QOL were assessed using EQ-5D-5L Arabic version. RESULTS: 131 participants were included in the study with a median age 55 years old. Forty five percent of participants were male. Regarding EQ-5D scores, there were significant correlation with gender, exercise, hypertension, heart disease, marital status, educational level and duration of diabetes while there was a significant difference in EQ-VAS scores with respect to heart disease, level of education and duration of diabetes. CONCLUSION: More attention needs to be given to the assessment of the QOL of diabetic patients and assessing the effect of different treatment modalities on improvement of patients' QOL.

Oral antidiabetic medication adherence and glycaemic control among patients with type 2 diabetes mellitus: a cross-sectional retrospective study in a tertiary hospital in Saudi Arabia.

OBJECTIVES: The purpose of this study is to measure the adherence rates of oral antidiabetic drugs (OADs) in patients with type 2 diabetes mellitus (T2DM) and assess the relationship of glycaemic control and adherence to OADs after controlling for other associated factors. DESIGN: Cross-sectional retrospective study. SETTING: Large tertiary hospital in the central region of Saudi Arabia. PARTICIPANTS: 5457patients aged 18 years and older diagnosed with T2DM during the period from 1 January 2016 to 31 December 2016. PRIMARY AND SECONDARY OUTCOME MEASURES: The modified medication possession ratio (mMPR) was calculated as a proxy measure for adherence of OADs. The factors associated with OADs non-adherence and medication oversupply were assessed using multinomial logistic regression models. The secondary outcomes were to measure the association between OADs adherence and glycaemic control. RESULTS: Majority of patients with T2DM were females (n=3400, 62.3%). The average glycated haemoglobin was 8.2±1.67. Among the study population, 48.6% had good adherence (mMPR >0.8) and 8.6% had a medication oversupply (mMPR >1.2). Good adherence was highest among those using repaglinide (71.0%) followed by pioglitazone (65.0%) and sitagliptin (59.0%). In the multivariate analysis, women with T2DM were more likely to have poor adherence (adjusted OR (AOR)=0.76, 95% CI=0.67, 0.86) compared with men. Also, medication oversupply was more likely among patients with hyperpolypharmacy (AOR=1.88, 95% CI=1.36, 2.63), comorbid osteoarthritis (AOR=1.72, 95% CI=1.20, 02.45) and non-Saudi patients (AOR=1.53, 95% CI=1.16, 2.01). However, no association was found between glycaemic control and adherence to OADs. CONCLUSION: The study findings support the growing concern of non-adherence to OADs among patients with T2DM in Saudi Arabia. Decision makers have to invest in behavioural interventions that will boost medication adherence rates. This is particularly important in patients with polypharmacy and high burden of comorbid conditions.

Measuring the quality and completeness of medication-related information derived from hospital electronic health records database.

OBJECTIVE: Electronic Health Records (EHRs) database is a great source for pharmacoepidemiological research as thousands of patients' clinical and medication information is stored in the database. However, the use of EHRs database for research purposes depends greatly on the accuracy and completeness of the data being used. This study mainly aimed to assess the completeness of EHRs patients' medication-related information. DESIGN: A retrospective cross-sectional study using data extracted from the EHRs database was conducted. SETTING: The EHRs data was obtained from a single tertiary hospital in Saudi Arabia. MAIN OUTCOME MEASURES: The completeness of data was measured considering if a patients' record contains all desired types of data (i.e., patients' demographics, clinical diagnosis, and medication-related information). RESULTS: A total of 23,411 unique individuals were identified after extracting the data from the EHRs. The study found that 89.9% of the patients had a complete data (i.e., age, gender, marital status, nationality, encounter type, and clinical diagnosis). Further, 83.1% of the patients had complete medication-related information. Subgroup analysis by the encounter type indicated that the data was 91.0% complete for outpatient encounter and 93.2% complete for inpatient encounter. CONCLUSION: The study findings indicate that the completeness of the data varies by the desired types of data. EHRs can be a potentially great resource to conduct research to assess medication use. Further studies focusing on the content and completeness of EHRs for a specific patient population and evaluate other dimensions of EHRs data quality are needed.

Factors associated with glycemic control in type 2 diabetic patients in Saudi Arabia.

OBJECTIVE: To identify factors associated with glycemic control in type 2 diabetes mellitus patients in tertiary academic hospital. RESEARCH DESIGN AND METHODS: This was a retrospective cross-sectional study of adults with type 2 diabetes mellitus. Data were extracted from the electronic health record (EHR) database for the period from 1st of January to 31st of December 2016. Participants were considered to have a glucose control if the HbA1c level was less than 7% [53 mmol/L]. Descriptive analysis and multivariable logistic regression model were performed to assess the factors associated with glycemic control. RESULTS: A total of 728 patients were included in the study for which (65%) were female, and about 60% of the sample size was between 45 and 60 years old. Multivariate logistic regression model showed participants older than the age of 65 were less likely to have controlled diabetes compared to the younger participants (OR: 0.53 [CI: 0.30-0.93]). Moreover, those who had hypertension (OR: 0.61 [CI: 0.43-0.86]) and dyslipidemia (OR: 0.53 [CI: 0.38-0.74]) were less likely to have controlled diabetes, while those with asthma (OR: 2.06 [CI: 1.16-3.68]) were more likely to have controlled diabetes. The model also showed that vitamin D deficiency was not associated with glycemic control in type 2 diabetes patients (OR 0.80 [95% CI 0.58-1.12]). CONCLUSION: These findings highlighted the need for appropriate management in older adult patients to prevent the complication of type 2 diabetes. Furthermore, attention should be exercised for patients with factors associated with poor glycemic control such as hypertension and dyslipidemia.

Advancing pharmaceuticals and patient safety in Saudi Arabia: A 2030 vision initiative.

Low-quality medicines deliver sub-optimal clinical outcomes and waste precious health resources. It is important to ensure that public funds are spent on healthcare technologies that meet national regulatory bodies such as the Saudi Food and Drug Authority (SFDA), quality standards for safety, efficacy, and quality. Medicines quality is a complicated combination of pre-market regulatory specifications, appropriate sourcing of ingredients (active pharmaceutical ingredient (API), excipients, etc.), manufacturing processes, healthcare ecosystem communications, and regular and robust pharmacovigilance practices. A recent conference in Riyadh, sponsored by King Saud University, sought to discuss these issues and develop specific policy recommendations for the Saudi 2030 Vision plan. This and other efforts will require more and more creative educational programs for physicians, pharmacists, hospitals, and patients, and, most importantly evolving regulations on quality standards and oversight by Saudi health authorities.

The association of vitamin D deficiency and glucose control among diabetic patients.

OBJECTIVE: To evaluate the association between the level of vitamin D and glycemic control among patients with diabetes. RESEARCH DESIGN AND METHOD: We analyzed data collected from NHANES 2003-2006. We included only non-pregnant adult diabetic persons 18 years or older. Participants who had vitamin D level less than 20 ng/ml were considered as having vitamin D deficiency. Participants were considered to have a glucose control if the HbA1c level was less than 7% [53 mmol/L]. We used student's t test to compare the difference in HbA1c means between people with Diabetes with and without a vitamin D deficiency. We used a multivariate logistic regression model to predict the relationship between glucose control and vitamin D deficiency. We used race/ethnicity, BMI, age, gender, type of diabetic medication used, having health insurance or not, and comorbid conditions (hypertension, anemia, cholesterol, liver disease, and kidney disease) as control variables. RESULTS: The study population included a total of 929 non-institutionalized, non-pregnant, diabetic adult persons. About 57% of patients with diabetes had a vitamin D deficiency. Blacks (non-Hispanic patients) with diabetes had the highest rate of vitamin D deficiency (79%). The unadjusted means of HbA1c were significantly different between diabetic patients with no vitamin D deficiency and those with a vitamin D deficiency (7.06% [54 mmol/L], 7.56 % [59 mmol/L], respectively, P < 0.0001). Multivariate adjustment showed a small but not significant, increase in odds (11%) of having uncontrolled diabetes in patients with a vitamin D deficiency after adjustment for other factors. CONCLUSION: Vitamin D deficiency is very common in patients with diabetes. We found no significant association between vitamin D level and glycemic control in patients with diabetes after adjustment for control variables.