Knowledge and Barriers Among Physicians Toward Adverse Drug Reaction Reporting at a Tertiary Care Hospital in Saudi Arabia

Background:Spontaneous reporting systems are essential as they help detect serious unknown adverse drug reaction (ADR). However, underreporting of ADR is a commonly associated problem. This research work aims to assess knowledge, barriers, and factors that encourage the reporting of ADR among physicians.Methods:A total of 600 physicians working at a tertiary referral hospital in Riyadh, Saudi Arabia, were included in this cross-sectional study. A pretested questionnaire was used.Results:Out of the 600 physicians, 240 (40%) completed the questionnaire. Most of the participants (85.4%) could correctly define ADR; nearly 75% physicians were unaware of the spontaneous reporting of ADR in Saudi Arabia. A total of 175 (72.9%) physicians had not reported any ADR among their patients in the last year; 40% of the physicians said that they did not report ADR because they were unaware of the online reporting of ADR. Providing guidelines and regular bulletins on the reporting of ADR is a critical aspect that encourages physicians to report ADR (51%). Education and training are the most recognized measures for improving the reporting of ADR.Conclusion:Physicians were adequately aware of ADR but inadequately aware of the reporting system and reporting authorities. Continuing medical education, training, and integration of the reporting of ADR into physicians’ various clinical activities may improve ADR reporting.     

Lipid-Lowering Efficacy of Ezetimibe in Patients with Atherosclerotic Cardiovascular Disease: A Systematic Review and Meta-Analyses

Patients with atherosclerotic cardiovascular disease (ASCVD), especially those with recent (< 1 year) acute coronary syndrome (ACS), are at high risk for recurrent cardiovascular events. This risk can be reduced by lowering low-density lipoprotein cholesterol (LDL-C) levels. A comprehensive meta-analysis on the LDL-C-lowering efficacy of ezetimibe is lacking. This study attempts to address this gap. A systematic literature review of randomized controlled trials evaluating the LDL-C-lowering efficacy of ezetimibe in the ASCVD population was conducted. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for publications from database inception to August 2018 and for conference abstracts from 2015 to August 2018. Meta-analyses were conducted to evaluate the LDL-C-lowering efficacy of ezetimibe in the ASCVD population and the recent ACS subgroup. In total, 12 studies were eligible for the meta-analyses. Treatment with combination ezetimibe plus statin therapy showed greater absolute LDL-C reduction than statin monotherapy (mean difference − 21.86 mg/dL; 95% confidence interval [CI] − 26.56 to − 17.17; p < 0.0001) after 6 months of treatment (or at a timepoint closest to 6 months). Similarly, in patients with recent ACS, combination ezetimibe plus statin therapy was favorable compared with statin monotherapy (mean treatment difference − 19.19 mg/dL; 95% CI − 25.22 to − 13.16; p < 0.0001). Ezetimibe, when added to statin therapy, provided a modest additional reduction in LDL-C compared with statin monotherapy. However, this may not be sufficient for some patients with ASCVD who have especially high LDL-C levels despite optimal statin therapy.     

从传统他汀及其联合治疗看调脂治疗的临床获益

摘要： 动脉粥样硬化性心血管疾病 （ASCVD） 是全球范围内主要的疾病负担, 亦是患者死亡的主要原因。既往大量关于他汀类药物调脂治疗的临床试验证实, 他汀类药物可有效降低 ASCVD 患者低密度脂蛋白胆固醇 （LDL-C） 水平、 全因死亡率和心血管病死亡率, 无 ASCVD 的患者亦可获益。然而, 目前无论是 ASCVD 高危患者还是无 ASCVD 的人群, 并未广泛应用降脂治疗。因此, 本文阐述了他汀类及其联合用药所带来的临床获益, 旨在增大受益人群, 改善预后。     

Statins are effective in treating dyslipidemia among psychiatric patients using second-generation antipsychotic agents

Statins are widely used in the treatment of patients having high levels of serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C). However, there is little documentation on the ability of statins to treat dyslipidemia induced by second-generation antipsychotics (SGAs) and if so, to what extent. A goal of the present study was to evaluate these aspects among psychotic inpatients who were prescribed SGAs in a typical clinical setting. The study sample consisted of 28 psychotic male forensic psychiatric inpatients (mean age 44 years). All had sGA medication for their psychotic symptoms. secondary causes of dyslipidemia were excluded and statin therapy was initiated, according to the established guidelines. The change in TC, LDL-C, high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) levels were evaluated retrospectively and analysed by the Wilcoxon signed Ranks test. The lowering effectivity of statin treatment was 36% for TC, 49% for LDL-C and 29% for TG. Most of the patients (84%) achieved a target value for LDL-C of <3.0 mmol/L, and 54% achieved target value of <2.6 mmol/L, while HDL-C remained unchanged. These results were achieved with a low or moderate dose of statin during a period of 1 month. The effect of statins in lowering of TC, LDL-C and TG among dyslipidemic psychiatric patients that were treated with sGA was similar to the effectiveness of statin therapy in other clinical trial settings, and should be used when they are indicated.     

LDL-C reductions and goal attainment among naive statin users in the Netherlands: real life results*

ABSTRACT

Objective: The effectiveness of statin therapy in a real life setting may differ from that in clinical trials, as physicians make non-randomised treatment decisions for patients with less uniform and possibly different characteristics. We therefore performed a study to compare the effectiveness of different statins and doses in routine clinical practice with respect to total serum cholesterol and LDL-cholesterol (LDL-C) reduction and goal attainment according to European guidelines on the prevention of cardiovascular disease (CVD).

Research design and methods: Naive statin users starting treatment in 2003 and 2004 with LDL-C measurements at baseline and between 30 and 365 days after start of treatment were extracted from the PHARMO database. During treatment with their initial statin dose LDL-C reduction and attainment of cholesterol goals were compared between different statins and doses.

Results: Of 2303 identified naive patients, approximately 30% were allocated to the high CVD-risk group. Average LDL-C reductions were 48%, 42%, 39%, and 32% at mean doses of 11 mg rosuvastatin, 17 mg atorvastatin, 22 mg simvastatin and 35 mg pravastatin, respectively. The proportion of patients attaining cholesterol goals was 75% for rosuvastatin, 68% for atorvastatin, 56% for simvastatin, and 42% for pravastatin. Dose comparisons showed greater LDL-C reduction and increased goal attainment for rosuvastatin 10 mg compared to other statins at most doses (adjusted p < 0.05).

Conclusions: In a real life setting, both LDL-C reduction and the proportion of patients attaining cholesterol goals appear to be significantly increased among users of rosuvastatin compared to other statins. These results confirm and extend reported clinical trial results to a real world setting.     

An overview of rosuvastatin/ezetimibe association for the treatment of hypercholesterolemia and mixed dyslipidemia

ABSTRACT

Introduction

Although statin therapy is a powerful lipid-lowering strategy, only one-fifth of statin users currently reach their lipid goals. In addition, statin treatment alone has relatively low efficacy in reducing other lipid fractions than low-density lipoprotein-cholesterol (LDL-C). In such cases, most guidelines recommend adding the cholesterol absorption inhibitor ezetimibe.     

Nurses’ readiness to prescribe under supervision in Saudi Arabia: A cross-sectional study

AimTo explore nurses’ readiness to prescribe medications under supervision and identify associations between prescribing practices under supervision and demographic characteristics in Saudi Arabia.DesignA cross-sectional study.MethodsUsing convenience sampling, this study used a 32-item survey to collect data on nurses prescribing medications under supervision between December 2022 and March 2023.ResultsA total of 379 nurses were recruited from different regions in Saudi Arabia. Approximately 7% (n = 30) of the participants were prescribing medications independently, and 70% (n = 267) expressed their likelihood of becoming prescribers. The highest motivating factors to become prescribers were improvement of patient care (52.2%) and contribution to the multidisciplinary team (52.0%). Most participants (60%–81%) agreed that prescribing medications under supervision would improve potential outcomes at the system, nurse, and patient levels. Availability of appropriate mentors or supervisors (72.9%) was the highest rated facilitating factor, followed by support of nursing colleagues (72%). Based on demographic characteristics, findings revealed significant differences in the: a) likelihood and motivators of becoming prescribers; b) required minimum qualification, years of experience, and continuing professional education hours to become prescribers; and c) type of organizations delivering educational programs for nurse prescribing.ConclusionMajority of nurses in Saudi Arabia favored becoming prescribers, and motivating factors were mostly relevant to optimizing patient care outcomes. Having the proper supervision was rated as the most facilitating factor for nurse prescribing. Nurses’ views on potential outcomes, facilitating factors, and possible motivators varied based on nurses’ demographical characteristics.Implications for the professional and/or patient careNurses favored prescribing under supervision to improve patient care outcomes, which is an opportunity to expand the benefits of health services, including easy access to healthcare.ImpactResults revealed that nurses support the implementation of prescribing practice under supervision. Thus, the findings may inform practice change in Saudi Arabia to allow prescribing under supervision, which was perceived to have a positive impact on patient care outcomes.Reporting MethodThis study adhered to STROBE guidelines.     

Blood pressure and lipid target adherence in Korean patients receiving angiotensin II receptor blockers/statin regimens

Objectives: Hypertension and dyslipidemia are important cardiovascular risk factors. Simultaneously controlling blood pressure (BP) and lipid levels is effective in preventing cardiovascular events and premature death. This study investigated the association between adherence to angiotensin II receptor blocker (ARB)/statin regimens and BP or low density lipoprotein-cholesterol (LDL-C) target attainment in Korean patients with concomitant hypertension and dyslipidemia.

Methods: In this retrospective, multicenter study, we collected case report forms (CRFs) of hypertensive patients with concomitant dyslipidemia who were prescribed an ARB/statin regimen between 1 April 2014 and 31 March 2015 from 51 outpatient clinics. A total of 672 and 609 patients were eventually included for statistical analyses of BP and LDL-C, respectively. Adherence was measured by medication possession ratio (MPR) for 6 months following the index date.

Results: The overall rates of attaining BP and LDL-C targets were 75.6% and 81.1%, respectively. The mean value of MPR for patients attaining target BP or LDL-C was significantly higher than that for those not attaining target BP or LDL-C. After adjustment for all covariates, increases in the quartiles of MPR were significantly associated with an increased probability of attaining target BP or LDL-C in all models (all p-trend <0.05). Attaining of BP control was significantly higher in quartiles 3 and 4 of MPR (MPR >0.95) than the lowest MPR (quartile 1), whereas attaining LDL-C target was associated with quartile 4 of MPR (MPR >0.97).

Conclusion: We identified a strong correlation between medication adherence and BP or LDL-C target achievement in Korean patients with concomitant hypertension and dyslipidemia. The adherence for reaching targets could be different between BP and LDL-C levels.     

Hospital pharmacy practice in Saudi Arabia: Prescribing and transcribing in the Riyadh region

PurposeThe purpose of this survey is to outline pharmacy services in hospitals on a regional level in the Kingdom of Saudi Arabia.MethodsA modified-American Society of Health-System Pharmacists (ASHP) survey questionnaire as pertinent to Saudi Arabia was used to conduct a national survey. After discussing with the pharmacy directors of 48 hospitals in the Riyadh region over the phone on the survey’s purpose, the questionnaires were personally delivered and collected upon completion. The hospital lists were drawn from the Ministry of Health hospital database.ResultsTwenty-nine hospitals participated in the survey giving a response rate of 60.4%. Approximately 60% of the hospitals which participated in the survey required prior approval for the use of non-formulary medications. About 83.3% of hospitals reviewed compliance with clinical practice guidelines and 72.7% hospitals reported that pharmacists are also actively involved in these activities. Pharmacists in more than 95% of hospitals provided consultations on drug information. A staff pharmacist routinely answering questions was the most frequently cited (74.1%) method by which objective drug information was provided to prescribers. Electronic drug information resources were available in 77.7% of hospitals, although internet use is not widely available to hospital pharmacists, with only 58.6% of hospitals providing pharmacist access to the internet. About, 34.5% of hospitals had computerized prescriber order entry (CPOE) systems with clinical decision-support systems (CDSSs) and 51.9% of the hospitals had electronic medical record (EMR) system.ConclusionHospital pharmacists are increasingly using electronic technologies to improve prescribing and transcribing of medications in Saudi Arabia.     

Pharmacy practice research in Saudi Arabia; A bibliometrics analysis from (2000 to 2021)

BackgroundPharmacy is a growing profession in the Kingdom of Saudi Arabia which has experienced tremendous changes in the past 20 years. Pharmacy practice or clinical pharmacy have an attention ever since the emerging of PharmD programs throughout the Saudi universities. As a result, the number of affiliated faculty in the pharmacy practice departments has increased dramatically in the past 20 years and thus significant changes in research output were observed.ObjectivesThe main objective is to conduct a bibliometric analysis and evaluate the research output of pharmacy practice faculty in Saudi Universities from 2000 to 2021MethodsA systematic search was conducted using Scopus database to explore the research output from pharmacy practice affiliated faculty from 2000 to 2021. The following search terms AFFILORG (“Pharmacy Practice Department” OR “Department of Pharmacy practice” OR “Clinical Pharmacy Department” OR “Department of Clinical Pharmacy” OR “Department of Pharmacy Services”) AND AFFILCOUNTRY (“Saudi Arabia” OR “KSA” OR “Kingdom of Saudi Arabia”) were used. Only original research papers were retrieved and analyzed using MS Excel (v16.0), MS Access (v16.0), Bibexcel (v2017), VOS viewer, and Biblioshiny.ResultsIn the past two decades, most publications with pharmacy practice departments affiliation were pharmacy practice research irrelevant (only 1075 out of 2809). King Saud University and King Abdulaziz University were the top performing institutes, and median of 5-year impact factor for journals was more than 3 for most of the top 10 institutes. 19% of the total retrieved articles were review publications were the rest majorly classified as cross-sectional studies.ConclusionThe research contribution of pharmacy practice departments in Saudi Arabia has been improving. Key recommendations are to promote more applied and interventional research, increase publications in top journals, and enhance national collaborations.     

Antidote Availability in Saudi Arabia Hospitals in the Riyadh Province

Inadequate antidote stocking is a global problem in hospitals. Insufficient supplies and delays in the administration of antidotes could lead to death and additional potentially negative clinical consequences. Our objective was to determine the availability of antidotes in hospitals listed on the Saudi Ministry of Health website in the Riyadh Province and to evaluate the leading poison in Saudi Arabia. A cross‐sectional study was conducted using questionnaires. The questionnaires were distributed to pharmacist directors and emergency room‐treating physicians in 17 public hospitals throughout the Riyadh Province. None (0/17) of the pharmacies contained the 24 recommended essential antidotes by the expert consensus guidelines for stocking of antidotes in hospitals. Polyvalent scorpion antivenom, atropine sulphate, calcium gluconate, flumazenil and naloxone hydrochloride were stocked in 94.12% (16/17) of hospitals. 66.67% of patients presented with osmolality, and 55.56% of referral patients with opiates, barbiturates, acetaminophen and salicylate. Our findings have important implications for healthcare institutions and pharmaceutical practices. National practice guidelines are needed to assist pharmacists in selecting appropriate antidotes based on the local pattern of poisoning incidents. Therefore, further study in the Kingdom of Saudi Arabia needs to be completed to fully evaluate the availability of antidotes throughout the country.     

Views,experiences and contributory factors related to medication errors associated with direct oral anticoagulants: a qualitative study with physicians and nurses

Background

Direct oral anticoagulants (DOACs) have become preferable for the management of thromboembolic events. Recent publications have however identified high volume of medication errors related to DOACs. There is limited literature on why and how such errors occur or happen in clinical practice.

Aim

This study aimed to explore views, experiences, contributory factors related to DOACs medication errors from the perspectives of healthcare professionals.

Method

Semi-structured interviews using online videoconferencing were conducted with physicians and nurses from tertiary care hospitals in three different regions in Saudi Arabia. Questions included views, experiences and perceived factors contributing to errors. Interviews were transcribed verbatim and were thematically analyzed using MAXQDA Analytics Pro 2020 (VERBI Software).

Results

The semi-structured interviews (n?=?34) included physicians (n?=?20) and nurses (n?=?14) until data saturation was achieved. The analysis identified five themes: Factors related to healthcare professionals (e.g. knowledge, confidence and access to guidelines); Factors related to patients (e.g. comorbidity, polypharmacy, medication review, and communication barriers); Factors related to organization (e.g. guidelines, safety culture and incidents reporting system); Factors related to the DOACs medications (e.g. lack of availability of antidotes and dosing issues); and Strategies for error prevention/mitigation (e.g. the need for professional training and routine medication review).

Conclusion

Healthcare professionals identified errors in relation to DOACs as multifactorial including their own and patient lack of knowledge, lack of clinical guidelines and organizational factors including safety culture. Medication review and reconciliation on discharge were key strategies suggested to reduce DOACs related errors. These strategies support the role of pharmacists as direct patients care providers to minimize DOACs errors.

     

LDL cholesterol levels after switch from atorvastatin to rosuvastatin

Objective: Initial statin therapy may not always adequately reduce elevated low-density lipoprotein cholesterol (LDL-C) levels. Although alternative therapies are available, switching to another statin may be beneficial, especially for those at highest risk of cardiovascular disease and events. This study examined changes in LDL-C levels following a switch from 40/80?mg of atorvastatin (ATV) to 20/40?mg of rosuvastatin (RSV).

Methods: This retrospective cohort study used data from the MarketScan administrative claims databases linked to laboratory values. Patients with or at risk for atherosclerotic cardiovascular disease (ASCVD) who switched from ATV 40/80?mg to RSV 20/40?mg and had LDL-C values measured within 90 days before and 30–180 days after the switch were included. The change in LDL-C was quantified for each patient and summarized across all patients and within each switch pattern (e.g. ATV40 to RSV20).

Results: There was a significant mean (SD) decrease in LDL-C of 21% (30%) across the whole sample (N?=?136) after switching from ATV to RSV. The greatest decrease occurred in patients who switched from ATV40 to RSV40 (N?=?20; ?29% [19%]; p?N?=?112; ?24% [24%]; p?Conclusions: Switching from ATV to RSV was associated with a significant decrease in LDL-C among high-risk patients. Switching between these two high-intensity statins may offer a viable alternative to other treatment modifications aimed at lowering LDL-C in this population.     

Spotlight from the American Society for Preventive Cardiology on Key Features of the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guidelines on the Management of Blood Cholesterol

The 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol retains focus on recommendations for statin treatment in the original four statin-eligible groups [those with atherosclerotic cardiovascular disease (ASCVD), diabetes, low-density lipoprotein cholesterol (LDL-C) ≥ 190 mg/dL, and higher risk primary prevention] without the use of treatment initiation or target LDL-C levels from the earlier 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline, but has several new features. First, patients with primary prevention are divided into those who are at low (< 5%), borderline (5% to < 7.5%), intermediate (7.5% to < 20%), and high (≥ 20%) risk based on the ASCVD risk estimator. Moreover, the new guideline goes further to consider a wider range of factors [now called “risk enhancers”—premature family history of ASCVD, persistently high LDL-C, chronic kidney disease (CKD), metabolic syndrome, conditions specific to women, inflammatory diseases, and high-risk ethnicities] that can be used to better inform the treatment decision. Moreover, more detailed recommendations on how the results of coronary calcium scanning can be used to inform the treatment decision are provided, including how it may be used to “de-risk” certain patients for delaying or avoiding the use of statin therapy. There are also specific sections for cholesterol management in other patient subgroups including women, children, certain ethnic groups, those with CKD, chronic inflammatory disorders and HIV, as well as discussion on the management of hypertriglyceridemia. Importantly, for persons with known ASCVD, a distinction is made for those who are at “very high risk” based on having had two major ASCVD events or one major event and two or more other high risk conditions, such as diabetes or other major risk factors, or bypass surgery or percutaneous intervention. Finally, the concept of a threshold LDL-C for initiating a non-statin therapy (after considering highest tolerated statin dosage) is provided, with ezetimibe recommended as the key non-statin to be added if the LDL-C still remains ≥ 70 mg/dL for all ASCVD patients, and in those who are at “very high risk”, further consideration for using a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. While the new guideline does have greater detail (and arguably, complexity), the refinements provide a strategy for guiding the clinician to target both statin and non-statin therapy to those most likely to derive benefit.     

Efficacy and Safety of Fenofibric Acid Co-Administered with Low- or Moderate-Dose Statin in Patients with Mixed Dyslipidemia and Type 2 Diabetes Mellitus

Background

Monotherapy with lipid-modifying medication is frequently insufficient to normalize lipid abnormalities in patients with mixed dyslipidemia and type 2 diabetes mellitus.

Objective

To evaluate the efficacy and safety of fenofibric acid + statin combination therapy in this population.

Study Design

A pooled, subgroup analysis of three randomized, controlled, double-blind, 12-week trials.

Setting

Multiple clinical research facilities in the US and Canada.

Patients

Patients with mixed dyslipidemia and type 2 diabetes (n= 586).

Intervention

Fenofibric acid (Trilipix®) 135 mg monotherapy; low-, moderate-, or high-dose statin monotherapy (rosuvastatin [Crestor®] 10, 20, or 40 mg; simvastatin [Zocor®] 20, 40, or 80 mg; or atorvastatin [Lipitor®] 20, 40, or 80 mg); or fenofibric acid + low- or moderate-dose statin.

Main Outcome Measure

Mean percentage changes in lipid parameters, percentages of patients achieving optimal serum lipid/apolipoprotein levels, and incidence of adverse events.

Results

Fenofibric acid + low-dose statin resulted in significantly (p<0.001) greater mean percentage changes in high-density lipoprotein cholesterol (HDL-C) [16.8%] and triglycerides (?43.9%) than low-dose statin monotherapy (4.7% and ?18.1%, respectively) and significantly (p<0.001) greater reductions in lowdensity lipoprotein cholesterol (LDL-C) [?34.0%] than fenofibric acid monotherapy (?5.3%). Similarly, fenofibric acid + moderate-dose statin resulted in significantly (p≤0.011) greater mean percentage changes in HDL-C (16.3%) and triglycerides (?43.4%) than moderate-dose statin monotherapy (8.7% and ?24.2%, respectively) and significantly (p<0.001) greater reductions in LDL-C (?32.6%) than fenofibric acid monotherapy (?5.3%). Compared with low- or moderate-dose statin, fenofibric acid + low- or moderate-dose statin resulted in over 5-fold higher percentages of patients achieving optimal levels of LDL-C, non-HDL-C, apolipoprotein B, HDL-C, and triglycerides simultaneously. Incidence of adverse events was generally similar among treatments.

Conclusion

Fenofibric acid + statin combination therapy in patients with mixed dyslipidemia and type 2 diabetes was well tolerated and resulted in more comprehensive improvement in the lipid/apolipoprotein profile than either monotherapy.