The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study

PurposeThis study aimed to assess the type, severity, seriousness, reasons, and outcomes of adverse drug reactions (ADRs) in the reports submitted to the regional spontaneous ADR database.MethodsA retrospective observational study was conducted to analyze all the Tabuk Health Affairs hospitals in Saudi Arabia submitted to SFDA from January 2020 to December 2020. The database was structured according to the Saudi ADR form’s fields. The Naranjo algorithm was used to assess the causes of the ADRs (sFDA, 2022).ResultsFor 1 year, 2,349 ADR reports, along with 242 suspected drugs for 4,114 reactions, were submitted to SFDA. We found more males than females had ADRs (56.1% vs. 43.8%, P < 0.05).Antimicrobial drugs (26.9%), hematologic drugs (19.7%), and neuropsychiatric drugs (12.9%) were responsible for most ADRs. Most of the reactions were associated with the use of ciprofloxacin (7.7%), followed by the combination of lopinavir and ritonavir (4.1%). Two deaths resulted from salbutamol and cefazolin use. Based on the results of the Naranjo assessment of causality, cardiovascular events (9.9%) exhibited the highest score (≥9) for a causal relationship with the suspected drugs, followed by dermatological events (9.5%).ConclusionsThe spontaneous report database is an important and valuable source of aftermarket authorization safety information. In our study, most drugs used as antimicrobial, cardiovascular, and hematologic therapies were associated with a higher risk of developing severe and serious events. We recommend monitoring and using medications optimally to ensure patient safety.     

Pharmacist-led medication reconciliation at patient discharge: A scoping review

BackgroundOne of the strategies to promote patient safety in care transitions is medication reconciliation (MR), which is conducted by the pharmacist at the patient's discharge from hospital. However, there are divergences about this process and about the pharmacist's role in conducting such intervention.ObjectiveTo systematically review the literature that reports the MR process led by pharmacists at patient discharge and map the different methods, strategies and tools used in the process.MethodsRelevant studies were searched in the following databases: EMBASE, MEDLINE (PubMed), The Cochrane Library, and LILACS. No language restriction or publication date was applied. The studies considered eligible were those involving and describing pharmacist-led MR processes at acute patient discharge from hospital, with an experimental, quasi-experimental, or observational design. The characteristics of the studies and the MR processes were identified and then a qualitative synthesis was performed.ResultsFifty studies were included. The majority of them were observational ones (82%), and the main outcome was medication discrepancies (42%). The studies were mostly conducted in university hospitals (70%) and in internal medicine wards (54%). Pharmacists were responsible mainly for gathering medication histories (72%), and identifying (96%) and solving (98%) pharmacotherapeutic problems. The main sources of information on pre-admission medications were patient/caregiver interviews (66%) and records from other care providers (40%). Only 30% of the studies described a patient discharge plan, and 14% shared information of the patient's pharmacotherapy with community pharmacists.ConclusionThe concept of MR and the pharmacist-led activities in the process varied in the literature, as well as the pharmacotherapy assessment focus and the communication strategies towards patients and other care providers, showing that standardization of the process and concepts is necessary.     

Pharmacy practice in hospital settings in GCC countries: Dispensing and administration

PurposeTo outline dispensing and administration practices in hospital pharmacy across the Gulf Cooperation Councils (GCC) countries’ hospitals. Paucity of data in appraising hospital pharmacy practice in GCC regions motivated us to conduct this study.MethodsA modified survey questionnaire was prepared from the American Society of Health-System Pharmacist (ASHP) survey questions. Three major domains of questions for general characteristics of the medication use process for dispensing and administration were identified. These were, (1) medication distribution system, and medication distribution technology, (2) technology used to compound sterile preparations, compounding I.V. medication and method of compounding nutrition support preparations, (3) medication administration practices, medication orders, medication administration records (MARs), and technician activities. A list of hospitals was obtained from the Ministry of Health of the targeted GCC countries. A secure invitation link containing a survey questionnaire was sent to the participants directly.ResultsSixty-four hospitals responded to this survey. The overall response rate was 52%. Most surveyed hospitals have centralized inpatient medications distribution system (75.0%). About 37.5% of hospitals used automated dispensing cabinets (ADCs) in their patient care areas. Compounding sterile preparations in the pharmacy, barcode verification technology, workflow management technology, and robotic technology were used by 17.2%, 15.6%, and 4.7% of hospitals, respectively. In using safety technology for medication administration, almost all hospitals have partially or completely implemented an electronic health record (EHR). About 40.6% of hospitals used electronic medication administration records (e-MARs), 20.3% used bar-code-assisted medication administration (BCMA), and 35.9% used smart infusion pumps.ConclusionThe results of this survey revealed an opportunity to improve the medication use management process on dispensing and administration practices in hospitals in GCC countries.     

The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia

BackgroundThe introduction of direct-acting antivirals (DAA) to treat the hepatitis C virus (HCV) overcame many drawbacks of interferon-based therapy. DAA achieved sustained viral response (SVR) rates above 90% and overcame many drawbacks of pegylated interferon regimens.The HCV genotype (GT) distribution varies by geographical area, with GT-4 being most prevalent in the Middle East region, including Saudi Arabia. Yet, the real-world evidence about using DAAs in the Saudi population is limited.Thus, the aim of this study to investigate the effectiveness and safety of DAAs in Saudi patients with HCV infection.MethodsA retrospective cohort study included patients treated with DAAs from 2015 to 2017 at a tertiary care hospital in Riyadh, Saudi Arabia. All patients with HCV treated with either ledipasvir plus sofosbuvir (LDS/SOF) ± ribavarin (RBV) or ombitasvir-paritaprevir-ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± RBV were included. Using a per-protocol analysis, the effectiveness outcome was the end-of-treatment response (EOTr) and Sustained virologic reponce12 weeks after competing the regimen (SVR12). The secondary safety outcome was the adverse event related to the therapy reported by the patients.ResultsA total of 97 patients were included; with the majority infected with GT-4 (64 %), followed by GT-1 (18 %), in addition to 8 % having a mixed GT (1 + 4). The EOTr and SVR12 rates were 98 % and 96 %, respectively. SVR12 was 94.4 % within the LDS/SOF ± RBV group and 97.7 % within the OBV/PTV/r ± DSV ± RBV group. Only 4 % had a response failure due to relapse or breakthrough, and all were infected with mixed GT1 + 4. Medications were well tolerated with minimal side effects, including vomiting, nausea, and weakness.ConclusionDAAs regimens are associated with high rates of SVR12 and are well tolerated with a good safety profile in Saudi HCV-infected patients.     

Pharmacy practice in hospital settings in GCC countries: Prescribing and transcribing

PurposeTo outline hospital pharmacy practices across the Gulf Cooperation Councils (GCC) countries’ hospitals.MethodsA modified survey questionnaire was prepared from the original 2019 American Society of Health-System Pharmacist (ASHP) survey questions. Survey details were discussed with some pharmacy directors for clarity and relevance. A list of hospitals were obtained from the Ministry of Health of each of the targeted GCC countries. A secure invitation link containing a survey questionnaire was sent to the participants directly.ResultsSixty four hospitals responded to this survey. The overall response rate was 52%. About 47% of the surveyed hospitals considered their drug formularies as closed, and strict. Additionally, only 44% of hospitals compare the effectiveness of products, when taking formulary decisions for drug inclusion. Forty-four percent of hospitals have computerized prescriber order entry (CPOE / EHR) system functionality for formulary system management. At about 39.1% hospitals, pharmacists have the responsibility for managing medication therapies, majority were engaged in providing anticoagulation therapies. About 61% of hospital pharmacies in GCC countries receive medication orders electronically, through CPOE/EHR. Majority (66%) of the hospitals in GCC countries have an active Antimicrobial Stewardship Program (ASP) while only 40% of pharmacists have a key role in providing clinical support. About 57.8% of hospital pharmacy directors reported that pharmacists do not provide ambulatory care clinical pharmacy services in their hospitals.ConclusionIn GCC countries’ hospitals, there are major areas for improvement to patient care of which pharmacists are uniquely qualified as the medication experts to have the most meaningful outcomes in all of the domains of safe medication use, medication therapy management, antimicrobial stewardship program and participation in outpatient clinics.     

Claims-based pharmacy markers for comprehensive medication management program case identification: Validation against concurrent and prospective healthcare costs and utilization

BackgroundThree claims-based pharmacy markers (complex, costly and risky medications) were developed to help automatically identify patients for comprehensive medication management.ObjectiveTo evaluate the association between newly-developed markers and healthcare outcomes.MethodsThis was a two-year retrospective cohort study using PharMetrics Plus patient-level administrative claims in 2014 and 2015. We included all claims from 1,541,873 individuals with: (1) 24-month medical and pharmacy enrollment in 2014 and 2015, (2) aged between 18 and 63 in 2014, and (3) known gender. Independent/control variables came from 2014 while outcomes came from 2014 (concurrent analysis) and 2015 (prospective analysis). Three pharmacy markers, separately or together, were added to four base models to predict concurrent and prospective healthcare costs (total, medical, and pharmacy) and utilization (having any hospitalization, having any emergency department visit, and having any readmission). We applied linear regression for costs while logistic regression for utilization. Measures of model performances and coefficients were derived from a 5-fold cross-validation repeated 20 times.ResultsIndividuals with 1+ complex, risky or costly medication markers had higher comorbidity, healthcare costs and utilization than their counterparts. Nine binary risky category markers performed the best among the three types of risky medication markers; the Medication Complexity Score and three-level complex category both outperformed a simpler complex medication indicator. Adding three novel pharmacy markers separately or together into the base models provided the greatest improvement in explaining pharmacy costs, compared with medical (non-medication) costs. These pharmacy markers also added value in explaining healthcare utilization among the simple base models.ConclusionsThree claims-based pharmacy indicators had positive associations with healthcare outcomes and added value in predicting them. This initial study suggested that these novel markers can be used by pharmacy case management programs to help identify potential high-risk patients most likely to benefit from clinical pharmacist review and other interventions.     

Comparing the impact of Hydroxychloroquine based regimens and standard treatment on COVID-19 patient outcomes: A retrospective cohort study

BackgroundPharmacological treatments including antivirals (Lopinavir/Ritonavir), Immuno-modulatory and anti-inflammatory drugs including, Tocilizumab and Hydroxychloroquine (HCQ) has been widely investigated as a treatment for COVID-19.Despite the ongoing controversies, HCQ was recommended for managing mild to moderate cases in Saudi Arabia . However, to our knowledge, no previous studies have been conducted in Saudi Arabia to assess its effectiveness.MethodsA hospital-based retrospective cohort study involving 161 patients with COVID-19 was conducted from March 1 to May 20, 2020. The study was conducted at Prince Mohammed bin Abdul Aziz Hospital (PMAH).The population included hospitalized adults (age ≥ 18 years) with laboratory-confirmed COVID-19. Each eligible patient was followed from the time of admission until the time of discharge. Patients were classified into two groups according to treatment type: in the HCQ group, patients were treated with HCQ; in the SC group, patients were treated with other antiviral or antibacterial treatments according to Ministry of Health (MOH) protocols.The outcomes were hospitalization days, ICU admission, and the need for mechanical ventilation.We estimated the differences in hospital length of stay and time in the ICU between the HCQ group and the standard care (SC) group using a multivariate generalized linear regression. The differences in ICU admission and mechanical ventilation were compared via logistic regression. All models were adjusted for age and gender variables.ResultsA total of 161 patients fulfilled the inclusion criteria. Approximately 59% (n = 95) received HCQ-based treatment, and 41% (n = 66) received SC. Length of hospital stay and time in ICU in for patients who received HCQ based treatment was shorter than those who received SC. Similarly, there was less need for ICU admission and mechanical ventilation among patients who received HCQ based treatment compared with SC, (8.6% vs. 10.7 and 3.1% vs. 9.1%). However, the regression analysis showed no significant difference between the two groups in terms of patient outcomes.ConclusionHCQ had a modest effect on hospital length stay and days in ICU compared with SC. However, these results need to be interpreted with caution. Larger observational studies and RCTs that evaluate the efficacy of HCQ in COVID-19 patients in the Saudi population are urgently needed.     

Prevalence of complementary and alternative medicine use among rheumatoid arthritis patients in Saudi Arabia

Background and aimThe use of complementary and alternative medicine (CAM) is unexplored among Saudi rheumatoid arthritis (RA) patients. The aim of this study was to estimate the prevalence and types of CAM used among patients with RA and factors associated with their use.Experimental procedureA cross-sectional study was conducted at rheumatology clinics in two tertiary hospitals located in Riyadh, Saudi Arabia. The data was collected between May 2017 and February 2018. Unpaired Student's t-tests, Chi-square tests, and Pearson correlation tests were used to compare users vs nonusers.ResultsA total of 438 patients (mean age = 49, SD ± 15 years; 89.7% females) were included in this study. Sixty seven percent of included patients had used CAM for their RA. The majority of CAM users were female (92.1%). The most frequently used CAM products were vitamin D (47%), calcium (37%), honey (15%), ginger (13%), turmeric (11%), black seeds (8%), and fenugreek (8%). One hundred ninety-six (45%) patients believe that CAM is safe, and 287 (96%) patients took it because they believed that CAM had “added benefits”. Statistically significant differences were found for gender, RA duration, erythrocyte sedimentation rate (ESR) level, and seropositivity between CAM users and nonusers (P = 0.019, P = 0.011, P = 0.022, and P < 0.0001, respectively). A significant correlation was found between the Erythrocyte Sedimentation Rate (ESR) level, RA duration and CAM use (r = 0.110, P = 0.022 and r = 0.121, P = 0.012, respectively). These data indicated that patients who used CAM had higher ESR level and longer disease duration than patients didn’t use CAM.ConclusionThere is a high prevalence of CAM use among RA patients. CAM use was perceived to add benefit and patients using it had higher ESR. Larger studies are needed to assess the use of CAM and its impact on RA and its management.     

Application of the health Belief Model to assess community preventive practices against COVID-19 in Saudi Arabia

BackgroundThe novel coronavirus disease (COVID-19) has affected hundreds of thousands of people across more than 200 countries. As the pandemic continues, the health agencies, worldwide, are recommending strict preventive practices to avert its transmission at community scale. We sought to predict the behavior of the Saudi population for adopting community preventive practices during the COVID-19 pandemic.MethodsAn online questionnaire consisting of 22 items pertaining to the Health Belief Model constructs was used to measure the perceived susceptibility and perceived severity of contracting COVID-19, along with the perceived benefits and perceived barriers to follow the Ministry of Health’s recommendations. The outcome was assessed by their readiness to be compliant with the community protective measures. Data were analyzed using STATA at significance level of 0.05.ResultsA total of 900 individuals received the online survey link, of which 688 (response rate: 76.4%) respondents consented to participate in the study. The mean age of the respondents was 31.39 (SD = 8.94). Positive associations were observed between perceived susceptibility (Beta: 0.24; p value < 0.001), perceived severity (Beta: 0.16; p value < 0.001), perceived benefits (Beta: 0.41; p value < 0.001), cue to action (Beta: 2.61; p value < 0.001) and the participation in community preventive practices during the pandemic of the COVID-19.ConclusionsHealth belief model's constructs of perceived susceptibility, severity, benefits and cue to action can be adopted to help strengthen COVID-19 limiting behaviors and prevention programs which can delivered through community pharmacies in Saudi Arabia as well as around the world.     

Phytochemical constituents and anticancer activities of Tarchonanthus camphoratus essential oils grown in Saudi Arabia

Tarchonanthus Camphoratus L. is traditionally known for its various medicinal purposes. In this study, the T. camphoratus essential oil (TCEO) was isolated via steam distillation, and its chemical constituents were determined using GC–MS. The in vitro antiproliferative effects of TCEO on A549, HepG2, MCF-7 cancer cells, and HUVEC non-tumor cells was investigated using an MTT assay. Flow cytometry analysis was conducted to evaluate cell cycle distribution using propidium iodide staining, and cell death mode using Annexin V-FITC/PI assays. The expression of some apoptosis related genes was investigated using qRT-PCR. Major constituents of TCEO included fenchol, borneol, 3-cyclohexene-1-methanol and 3-ethyl-3-methyl. Cell viability test showed that TCEO is highly effective against MCF-7 cells with IC₅₀ 12.5 µg/mL. Cell cycle arrest at the G1/S phase, and apoptosis mediation were evident in the presence of TCEO. Gene expression analysis of several pro-apoptotic and anti-apoptotic genes revealed the initiation of apoptosis in TCEO-MCF-7 cells. In conclusion, our study confirms the antiproliferative activity of the T. camphoratus essential oil.     

Investigation of the effects of different beverages on the disintegration time of over-the-counter medications in Saudi Arabia

Full disintegration of Oral solid dosage forms is critically important to achieve reliable clinical performance of the drug. Tablets/capsules are supposed to be taken with a full glass of water; however, many patients do not follow this recommendation as they administer their medications with beverages other than water. This study aims to assess the impact of different commonly consumed beverages in Saudi Arabia on the disintegration times of common over-the-counter (OTC) medication tablets and capsules in the Kingdom of Saudi Arabia. Five immediate release OTC drugs were chosen: Fevadol®, Solpadeine®, Ralaxon®, Artiz ®, and Brufen®. The disintegration times of these medications were assessed using a disintegration test in five beverages: Coca-cola, arabic coffee, orange juice, buttermilk and an energy drink. Times were compared to the disintegration time in water under two temperature conditions (37 °C and 5 °C). All beverages significantly increased the disintegration times of fevadol, solpadeine, and relaxon in comparison with water. The same was found for burfen, except that arabic coffee did not significantly increase disintegration time (p > 0.05). The disintegration time of artiz tablets was also significantly influenced by all beverages, except for Coca-cola and the energy drink, which had no significant impact on the disintegration time. The tested beverages should not be used as substitutes for water when ingesting medications. Patients should be advised to avoid consuming beverages other than water with therapeutic products. Increasing public awareness of drug-beverage interactions is needed.     

Clinical factors associated with increased length of stay and readmission in patients with medication-related hospital admissions: a retrospective study

BackgroundAdverse drug events (ADEs) remain a key contributor to hospitalisations, resulting in long hospital stays and readmissions. Information pertaining to the specific medications and clinical factors associated with these outcomes is limited. Hence, a better understanding of these factors and their relationship to ADEs is required.ObjectivesTo investigate medications involved, clinical manifestations of ADE-related hospitalisations, and their association with length of stay and readmission.MethodsA retrospective medical record review of patients admitted to a major, tertiary referral hospital in NSW, Australia, from January 2019 to August 2020 was conducted. ADEs were identified using Australian Refined Diagnosis Related Group (AR-DRG) codes: X40, X61, X62 and X64. Medications were classified per the Anatomical Therapeutic Chemical (ATC) classification system and clinical symptoms were classified per the International Classification of Disease (ICD) 9-CM. Logistic regression was performed to assess the relationship between medication and presentation classes with length of stay (≥2 days vs <2 days) and readmission.ResultsThere were 125 patients who met inclusion criteria (median age = 64 [interquartile range, 45–75] years; 53.6% male). Anti-thrombotic agents, opioids, antidepressants, antipsychotics, insulins and NSAIDs were the most implicated pharmacological classes. Neurological medications and falls were associated with a length of stay ≥2 days (adjusted odds ratio [aOR] 3.92, 95% confidence interval [CI] 1.48–10.33 and aOR 3.24, 95% CI 1.05–10.06, respectively). Neurological medications and neurological and cognitive disorders were associated with an increased likelihood of 90-day readmission (aOR 2.63, 95% CI 1.05–6.57 and aOR 3.20, 95% CI 1.17–8.75, respectively).ConclusionThis study identified neurological medications as high-risk for increased length of stay and readmission in those hospitalised due to ADEs. This highlights the need for judicious prescribing and monitoring of these medications.