Prevalence, contributory factors and severity of medication errors associated with direct-acting oral anticoagulants in adult patients: a systematic review and meta-analysis.

PURPOSE: This study aimed to estimate the prevalence, contributory factors, and severity of medication errors associated with direct acting oral anticoagulants (DOACs). METHODS: A systematic review and meta-analysis were undertaken by searching 11 databases including Medline, Embase, and CINHAL between January 2008 and September 2020. The pooled prevalence of errors and predictive intervals were estimated using random-effects models using Stata software. Data related to error causation were synthesised according to Reason's accident causation model. RESULTS: From the 5205 titles screened, 32 studies were included which were mostly based in hospitals and included DOAC treatment for thromboembolism and atrial fibrillation. The proportion of study population who experienced either prescription, administration, or dispensing error ranged from 5.3 to 37.3%. The pooled percentage of patients experiencing prescribing error was 20% (95% CI 15-25%; I2 = 96%; 95% PrI 4-43%). Prescribing error constituted the majority of all error types with a pooled estimate of 78% (95%CI 73-82%; I2 = 0) of all errors. The common reported causes were active failures including wrong drug, and dose for the indication. Mistakes such as non-consideration of renal function, and error-provoking conditions such as lack of knowledge were common contributing factors. Adverse events such as potentially fatal intracranial haemorrhage or patient deaths were linked to the errors but causality assessments were often missing. CONCLUSIONS: Despite their favourable safety profile, DOAC medication errors are common. There is a need to promote multidisciplinary working, guideline-adherence, training, and education of healthcare professionals, and the use of theory-based and technology-facilitated interventions to minimise errors and maximise the benefits of DOACs usage in all settings. PROTOCOL: A protocol developed as per PRISMA-P guideline is registered under PROSPERO ID = CRD42019122996.

Assessment of Pharmacists' Knowledge and Practices towards Prescribed Medications for Dialysis Patients at a Tertiary Hospital in Riyadh Saudi Arabia.

OBJECTIVE: The present study examined pharmacists' knowledge and practices towards prescribed medications for hemodialysis patients. The impact of a pharmacist's current positions and years of experience on practices and knowledge was also assessed. METHODS: A cross-sectional survey was distributed to pharmacists working at King Abdul-Aziz Medical City-Central Region over a period of 4 months from July to October in 2015. RESULTS: Of the 85 approached pharmacists, 66 pharmacists completed the questionnaire, among which 45 (68.2%), 9 (13.6%), and 12 (18.2%) of them were outpatient hospital pharmacists, discharge counselling pharmacists, and pharmacy practice residents, respectively. In total, 47 (55.3%) of the pharmacists sought drug information resources for newly prescribed medications to hemodialysis patients. Among the surveyed pharmacists, around two-thirds of them (63.6%) were completely confident during counselling hemodialysis patients, while 32% were moderately confident, and only 4.5% were not confident. All of the participating pharmacists checked each patient's allergic status before dispensing hemodialysis medications. The majority of the outpatient hospital pharmacists (35; 77.8%), discharge pharmacists (8; 88.9%), and the pharmacy practice residents (11; 91.7%) agreed that oral ciprofloxacin should be given after dialysis session on the same dialysis days, while 18 (40%), 5 (55.6%), and 9 (75%) of the outpatient hospital pharmacists, discharge pharmacists, and pharmacy practice residents agreed that IV route is preferred for hemodialysis patients to administer epoetin alfa, respectively. Sixty-six percent of discharge pharmacists (n = 6), 91.7% (n = 11) of the pharmacy practice residents, and 55.6% (n = 25) of the outpatient hospital pharmacists checked patient laboratory results prior to dispensing medications (p = 0.001). CONCLUSIONS: Despite the limited knowledge regarding some prescribed medications, most of the hospital pharmacists showed good practices toward dialysis patients.

Tele-pharmacy Anticoagulation Clinic During COVID-19 Pandemic: Patient Outcomes.

Introduction: It is well-established that clinical pharmacist-managed anticoagulation services achieve superior anticoagulation control, with a positive impact. At King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia, the structure of anticoagulation management is a pharmacist-managed specialty service. With the current COVID-19 situation, measures were taken to assure the continuity of patient care by establishing tele-pharmacy anticoagulation clinics. Materials and Methods: This was a prospective study with patients prescribed anticoagulation and followed up for 3 months. Since establishing the anticoagulation virtual clinic in March 2020, 270 patients were recruited in the study. The data collected included age, gender, comorbidities, indication for anticoagulation, intended duration of treatment, warfarin dose, testing of International Normalized Ratio (INR), INR target, range of INR values, time INR that was within the therapeutic range (TTR), and complications of therapy (bleeding and/or bruises). The patients were asked to complete the pharmacist satisfaction survey (PSS) after their consultation to assess patient satisfaction with the new virtual consultation system. Linguistic and cultural validation was conducted for the questionnaire. Results: A total of 270 patients were included in the study. The mean percentage of overall INR values in the range was 59.39% ± 32.84, and the mean time with the overall INR was within the therapeutic range 57.81% ± 32.08. Thirty-one percent of the sample had good anticoagulation control (time in therapeutic range >70%). The median satisfaction score was 32 (IQR 28-36) with a maximum score of 40. Conclusion: This is the first study to assess the tele-pharmacy anticoagulation clinic's efficiency and patient satisfaction in Saudi Arabia during the COVID-19 pandemic. This type of consultation was as effective as face-to-face consultations. The study also highlighted that though the reduction in the cost of care was not substantial, there was a significant increase in resource (clinical pharmacist) utilization as a result of this model. The adoption of tele-pharmacy resulted in time savings for the clinical pharmacists who can be utilized in many other improvement projects in adult ambulatory clinics to ensure the delivery of better quality and safe patient care.

Colistin-induced Nephrotoxicity in a Tertiary Teaching Hospital.

Colistin-induced nephrotoxicity is a well-known major adverse event, which may occur within seven days [early acute kidney injury (AKI)] with a high mortality rate of 70% or after seven days (late AKI). The main objective of this retrospective study is to assess the severity and associated risk factors for the development of colistin-related nephrotoxicity. An observational retrospective cohort study was conducted over 12 months (January-December 2017). All patients with a baseline normal renal function, who received intravenous colistin for >72 h, were included. Nephrotoxicity was defined using the RIFLE criteria (Risk, Injury, Failure, Loss, and End-stage renal disease). The demographic and clinical variables were retrieved from the hospital's electronic medical record system and compiled in an electronic database. All the statistical analysis was carried out by SAS JMP from SAS Institute Inc., Cary, NC. Seventy patients met the inclusion criteria. Colistin-induced nephrotoxicity occurred in 45.71% of the patients, of whom 40.6% were at Risk, 21.9% at Injury, and 37.5% at Failure according to RIFLE criteria. In patients who developed AKI, the average total colistin dose received before AKI was 4.4 mg/kg/day. More than half of the AKI group (53.13%) received an inappropriate total dose of colistin. Age, 65 years and older, was significantly associated with a high risk of nephrotoxicity (P <0.05), which developed within 6.8 ± 0.44 days from receiving a colistin dose. Clinical pharmacy services were consulted in 28.13% of the cases, and the dose was adjusted in 37.5% of the patients. Colistin nephrotoxicity is common and is associated more with older age group and inappropriate dosing.

The effect of the VKORC1 promoter variant on warfarin responsiveness in the Saudi WArfarin Pharmacogenetic (SWAP) cohort.

Warfarin is a frequently prescribed oral anticoagulant with a narrow therapeutic index, requiring careful dosing and monitoring. However, patients respond with significant inter-individual variability in terms of the dose and responsiveness of warfarin, attributed to genetic polymorphisms within the genes responsible for the pharmacokinetics and pharmacodynamics of warfarin. Extensive warfarin pharmacogenetic studies have been conducted, including studies resulting in genotype-guided dosing guidelines, but few large scale studies have been conducted with the Saudi population. In this study, we report the study design and baseline characteristics of the Saudi WArfarin Pharmacogenomics (SWAP) cohort, as well as the association of the VKORC1 promoter variants with the warfarin dose and the time to a stable INR. In the 936 Saudi patients recruited in the SWAP study, the minor allele C of rs9923231 was significantly associated with a 8.45 mg higher weekly warfarin dose (p value = 4.0 × 10-46), as well as with a significant delay in achieving a stable INR level. The addition of the rs9923231 status to the model, containing all the significant clinical variables, doubled the warfarin dose explained variance to 31%. The SWAP cohort represents a valuable resource for future research with the objective of identifying rare and prevalent genetic variants, which can be incorporated in personalized anticoagulation therapy for the Saudi population.

Pharmacist-led Medication Counseling for Patients Undergoing Hemodialysis: A Path to Better Adherence.

OBJECTIVE: The primary objective was to assess the satisfaction of patients undergoing hemodialysis regarding counseling services provided by pharmacists. The secondary objectives were to compare the effect of years on dialysis and the presence of comorbidities on patient satisfaction. METHODS: A total of 138 patients were included in the study, and all demographic and clinical variables were retrieved from the dialysis unit records of King Abdulaziz Medical City over a period of 4 months from July to October 2015. Chi-square test and Fisher's exact test were used for group comparisons at a significance level of 0.05. Results: Most patients aged between 51 and 75 years and had been on dialysis for 1 to 5 years; 94.9% of them had comorbidities. The overall satisfaction of patients toward pharmacy services was excellent (77.5%), and approximately 38.4% of patients thought that pharmacists were providing clear information about their prescribed medications. In addition, 55.8 % of the patients did not know that hemodialysis could affect the efficacy of their medications. Conclusions: Patients undergoing hemodialysis were somewhat satisfied with the counseling provided by the pharmacist. Moreover, there is a need for educational programs for patients undergoing hemodialysis that would increase awareness among hospital pharmacists to improve patients' medication knowledge.

Venous thromboembolism prophylaxis-prescribing patterns among elderly medical patients in a Saudi tertiary care center: success or failure?

BACKGROUND: Hospitalized elderly patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. We investigated the pattern of VTE prophylaxis administration among elderly medical patients and assessed its appropriateness based on the American College of Chest Physicians (ACCP) recommendations. METHODS: A cross-sectional single-center study was conducted between October 2019 and March 2020, including hospitalized (> 48 h), elderly (≥ 60 years), medical patients, and excluding patients receiving anticoagulant for other reason, having contraindication to thromboprophylaxis, or had VTE diagnosed within 48 h. The Padua prediction score was used to determine the patients' risk for VTE, and thromboprophylaxis use was assessed against the ACCP recommendations. RESULTS: The study included 396 patients with an average age of 75.0 ± 9.01 years, and most patients (71.7%) were classified as high risk for VTE development (Padua score ≥ 4 points). Thromboprophylaxis use was inappropriate in 27.3% of patients, of whom 85.2% were ineligible but still received thromboprophylaxis. Patients who were classified as low risk of VTE were more likely to receive inappropriate thromboprophylaxis (AOR = 76.5, 95% CI: 16.1-363.2), whereas patients with acute infection or rheumatologic disorder were less likely to receive inappropriate thromboprophylaxis (AOR = 0.46, 95% CI: 0.22-0.96). CONCLUSIONS: Although the use of thromboprophylaxis among high-risk elderly patients was reasonably adequate, a large proportion of low-risk patients were exposed to unnecessary risk through inappropriate overutilization of thromboprophylaxis. Thus, healthcare providers should accurately assess patients' risk before prescribing thromboprophylaxis to ensure patient safety.

Mental Health Outcomes Amongst Health Care Workers During COVID 19 Pandemic in Saudi Arabia.

Objectives: The study aimed to assess the mental health outcomes and associated factors among health care workers during COVID 19 in Saudi Arabia. Design, Setting, and Participants: We conducted a cross-sectional survey of health care workers from tertiary care and ministry of health Centers across the Central, Eastern, and Western regions of Saudi Arabia. There were 1,130 participants in the survey, and we collected demographic and mental health measurements from the participants. Primary Outcomes and Measures: The magnitude of symptoms of depression, anxiety, and insomnia was measured using the original version of 9-item patient health questionnaire (PHQ-9), the 7-item generalized anxiety disorder scale (GAD-7), and 7-item insomnia severity index (ISI). We use the multiple logistic regression analysis to identify the associated risk factors of individual outcomes. Results: The scores on the PHQ-9 showed that the largest proportion of health care workers (76.93%) experienced only normal to mild depression (50.83 and 26.1%, respectively). The scores on the GAD-7 showed that the largest proportion of health care workers (78.88%) experienced minimal to mild anxiety (50.41 and 28.47%, respectively). The scores on the ISI showed that the largest proportion of health care workers (85.83%) experienced absence to subthreshold insomnia (57.08 and 28.75%, respectively). The risk factors for depression in health care workers were Saudi, living with family, working from an isolated room at home and frontline worker. For anxiety, being female was risk factor and for insomnia, being frontline worker was risk factor. Conclusion: It was observed that the symptoms of depression, anxiety, and insomnia were reported in a lower proportion of health care workers in our study. The participants who were female, frontline workers, Saudi, living with family, and working from home in isolated rooms were predisposed to developing psychological disorders.

Assessment of safety and effectiveness of oral multiple sclerosis medication.

OBJECTIVES: To assess the effectiveness and safety profile of the new disease modifying drugs (fingolimod, teriflunomide, and dimethyl fumarate) at a local hospital in Riyadh, Saudi Arabia. METHODS: This is a retrospective cohort, where institutional review board approval was granted in December 2015. The study was conducted at King Abdulaziz Medical City Research Center, Riyadh, Saudi Arabia. Demographic variables (age, gender, disease onset, and duration on medication), clinical variables (medication side effects and radiological findings), in addition to relapse frequency per year was collected. RESULTS: Fifty-seven patients' records were retrieved from the pharmacy and included in the analysis. Eight patients were on teriflunomide, 5 patients on dimethyl fumarate and 44 patients on fingolimod were enrolled. The patients' average age was 32.5 years with female gender representing 63% the study population. Annual relapse rates were 0.24, 0.34, and 0.5 per patient per year for those taking fingolimod, dimethyl fumarate, and teriflunomide, correspondingly, lymphopenia (91.4%), neutropenia (23%), and bradycardia (16%) were the most reported side effects for fingolimod therapy. CONCLUSION: The study results were able to capture the effectiveness rate for the targeted treatment in the studied population, with the frequency of incidence of side effects. However, as these results cannot be generalized for the entire Saudi population.

Drug resistant tuberculosis in Saudi Arabia: an analysis of surveillance data 2014-2015.

Background: There is limited data that investigates the national rates of drug-resistant tuberculosis (TB) in Saudi Arabia.This study aimed to estimate the rates of multi-drug-resistant tuberculosis (MDR-TB), rifampicin-resistant tuberculosis (RR-TB), and monoresistance (MR) in Saudi Arabia. Methods: A retrospective cohort study was conducted on all TB cases reported to the National TB Control and Prevention Program (NTCPP) registry at the Saudi Ministry of Health between January 1, 2014 and December 31, 2015. A total of 2098 TB patients with positive TB cultures were included in the study. Subgroup analyses and multivariate binary logistic regression models were performed with IBM SPSS 23.0. Results: Of the total TB cases, 4.4% (95% CI: 3.59%-5.40%) were found to have MDR-TB. The rates of MR were 3.8% (95% CI: 2.99%-4.67%) for ethambutol, 5.4% (95% CI: 4.50%-6.49%) for pyrazinamide, 10.2% (95% CI: 5.89%-11.52%) for isoniazid, 11% (95% CI: 9.70%-12.43%) for streptomycin, and 5.9% (95% CI: 4.90%-6.96%) for rifampicin. The high rates of MDR and RR-TB were found among the younger age group, female gender, and those who had a previous history of TB. We also discovered that renal failure tends to increase the risk of rifampicin resistance. Conclusions: National TB data in Saudi Arabia shows that the rate of MDR-TB was similar to the global rate reported by the World Health Organization (WHO). It is a relatively high rate as compared to Western countries. The proportion of MDR/RR-TB patients tends to be higher in the younger age group, female gender, and in patients with a previous history of TB treatment. Effective strategies for prevention of all multi-drug-resistant TB cases are warranted.

Assessment of patient-controlled analgesia versus intermittent opioid therapy to manage sickle-cell disease vaso-occlusive crisis in adult patients.

BACKGROUND: Vaso-occlusive crisis (VOC) is one of the acute complications of sickle-cell disease (SCD). Treatment mainly relies on hydration and pain control by analgesics. The specific aim of this study was to assess potential health outcomes within the first 72 h of admission between intermittent and patient-controlled analgesia (PCA) by opioids among VOC patients. METHODS: A retrospective chart review study was conducted to determine SCD patients with VOC. Using the hospital electronic system, the following data were collected: patient's age, gender, blood pressure, heart rate, respiratory rate, oxygen saturation, and pain score on admission and daily for 3 days as well as the cumulative opioid analgesic dose for 72 h which is reported as morphine equivalent. RESULTS: One hundred and seventeen patients were screened over a period of 5 years. Of those, 99 (84.6%) met the study inclusion criteria, and 18 patients (15.4%) were excluded from the study. During the first 72 h of admission, a significant reduction in pain score was observed in patients on intermittent intravenous (IV) administration compared to those in the PCA group (P < 0.0004) where the mean pain scores were 3 and 5, respectively. The total amount of morphine administered over 72 h of admission was significantly higher in PCA group (777 ± 175 mg) as compared to the intermittent IV administration group (149 ± 74 mg) (P < 0.000003). Clinically significant hypotension or respiratory depression was not observed in both groups over the 72 h of admission. CONCLUSION: During the first 72 h of admission, intermittent IV administration of morphine was more effective than PCA infusion in pain control.

Assessment of anti-factor Xa activity of enoxaparin for venous thromboembolism prophylaxis in morbidly obese surgical patients.

BACKGROUND: Venous thromboembolism (VTE) can be encountered by 60% of hospitalized patients. Anticoagulants have been recommended to reduce the risk of VTE in patients with risk factors. However, no specific dosing recommendations for obese patients are provided in the current practice guidelines. The purpose of this study was to determine the efficacy and safety of weight-based dosing of enoxaparin for VTE prophylaxis among morbidly obese patients undergoing surgery. METHODS: Adult patients were enrolled if they have a body mass index (BMI) of ≥35 kg/m2 and were scheduled for surgery. These patients were prescribed enoxaparin (0.5 mg/kg subcutaneously [SC] once daily). Peak anti-factor Xa levels were measured 4 h after the third dose of enoxaparin. The primary outcome measure was to determine whether a weight-based dosing of enoxaparin of 0.5 mg/kg produce the anticipated peak anti-Xa levels (0.2-0.6 IU/m) among obese patients undergoing surgery. Secondary outcomes include the incidence of VTE, the incidence of minor or major bleeding, and the incidence of heparin-induced thrombocytopenia (HIT). RESULTS: Fifty patients were enrolled in the study. The mean age was 53 ± 16 years, 74% of the patients were female. The mean BMI was 40.5 ± 5, and the average enoxaparin dose was 50 ± 9.8 SC daily. Nearly 88% of the patients reached the target anti-factor Xa (0.427 ± 0.17). None of the patients developed HIT or VTE. There was no incidence of major or minor bleeding. CONCLUSIONS: Weight-based enoxaparin dose led to the anticipated peak anti-Xa levels (0.2-0.6 IU/mL) in most of the morbidly obese study patients undergoing surgery without any evidence of major side effects. The weight-based dosing of enoxaparin was also effective in preventing VTE in all patients. Although these results are promising, further comparative trials are needed in the setting of morbidly obese surgical patients.

Assessment and comparison of CHADS2, CHA2DS2-VASc, and HAS-BLED scores in patients with atrial fibrillation in Saudi Arabia.

AIMS: No previous reports on the utilization of CHADS2, CHA2DS2-VASc, and HAS-BLED scores in atrial fibrillation (AF) patients in Saudi Arabia have been identified in the literature. The main objectives of this study were to assess and compare the distribution of CHADS2, CHA2DS2-VASc, and HAS-BLED scores and to identify the most common risk factors for stroke and bleeding among AF patients attending clinical pharmacists managed anticoagulation clinic. SETTINGS AND DESIGN: This cross-sectional study was conducted over 2 months period at clinical pharmacists managed anticoagulation clinic. METHODS: CHADS2, CHA2DS2-VASc, and HAS-BLED scores were calculated and compared for all eligible patients. RESULTS: Two hundred and sixty-four patients with AF were included in the analysis. The number of patients at low risk for stroke was found to be 14 (5.3%) using CHADS2 and only 4 (1.5%) using CHA2DS2-VASc. On the other hand, 64 patients (24.2%) were found at moderate risk for stroke using CHADS2 compared with 17 patients (6.4%) using CHA2DS2-VASc. Most of the patients were found to be at high risk for stroke using either the CHADS2 (70.5%) and CHA2DS2-VASc (92%). The study also revealed that most of the patients were at moderate (63.3%) to high (27.7%) risk of bleeding. CONCLUSIONS: The results of this study show that the percentage of patients at high risk for stroke and bleeding is very high. The study revealed that this could be attributed to the high prevalence of modifiable risk factors for stroke and for bleeding in Saudi patients with AF.

A cross-sectional observational study to assess inhaler technique in Saudi hospitalized patients with asthma and chronic obstructive pulmonary disease.

OBJECTIVES: To assess the proportion of critical errors committed while demonstrating the inhaler technique in hospitalized patients diagnosed with asthma and chronic obstructive pulmonary disease (COPD).  METHODS: This cross-sectional observational study was conducted in 47 asthmatic and COPD patients using inhaler devices. The study took place at King Abdulaziz Medical City, Riyadh, Saudi Arabia between September and December 2013. Two pharmacists independently assessed inhaler technique with a validated checklist.  RESULTS: Seventy percent of patients made at least one critical error while demonstrating their inhaler technique, and the mean number of critical errors per patient was 1.6. Most patients used metered dose inhaler (MDI), and 73% of MDI users and 92% of dry powder inhaler users committed at least one critical error.   CONCLUSION: Inhaler technique in hospitalized Saudi patients was inadequate. Health care professionals should understand the importance of reassessing and educating patients on a regular basis for inhaler technique, recommend the use of a spacer when needed, and regularly assess and update their own inhaler technique skills.

Attitude, barriers and facilitators to practice-based research: cross-sectional survey of hospital pharmacists in Saudi Arabia.

BACKGROUND: Little is known about the perceived attitude, barriers and facilitators of Saudi Pharmacists about practice based research. We aimed to measure the attitude, barriers, and facilitators of Saudi hospital pharmacists towards pharmacy practice research. METHOD: A cross-sectional survey of hospital pharmacists (n = 216) working in King Abdulaziz Medical Cities in Central, Eastern and Western region hospitals was conducted during first week of September, 2013. The survey instrument comprised of six different sections that explored pharmacists previous participation in research, items regarding attitude, perception and willingness to participate, motivators, barriers, different areas of interest for doing research and patient demographics. Quantitative data collected was initially explored using frequency distribution, and descriptive analysis was carried out. Mann-Whitney U and independent samples t-test were used to explore the differences between the study variables. RESULTS: One hundred and eighty two pharmacists completed the survey yielding a response rate of 84 %. Fifty-nine percent of pharmacists have prior research experience. Pharmacists with research experience were more confident in reading and evaluating research papers (p = 0.01), and designing a research study (p = 0.001). Pharmacists with previous research experience were also more likely to participate in future research opportunities (p = 0.004) and were confident in their research skills (p = 0.003). No differences were observed about the perceived value of research, facilitators and barriers to participate in research, between pharmacists with prior research experience and pharmacists who have no prior experience to do research. CONCLUSION: Pharmacists in this study were unanimous about the importance of research but showed considerable differences in their confidence to carry out research. There is a need to provide additional support to enable Saudi pharmacists in conducting practice based research.