Mashael K. Alshaikh

Incidence of adverse drug events in an academic hospital: a prospective cohort study

OBJECTIVE To determine the incidence of adverse drug events (ADEs) and assess their severity and preventability. DESIGN A prospective cohort study. SETTING A 900-bed tertiary academic hospital. PARTICIPANTS A total of 977 patients admitted to two medical, one surgical and two intensive care units over four months. MAIN OUTCOME MEASURES The primary outcomes were the incidence of ADEs, preventability of ADEs, potential ADEs and medication errors. A physician and a clinical pharmacist independently determined the likelihood that incidents were caused by medications and judged severity and preventability. RESULTS Pharmacists reviewed the medical records of the 977 patients. Pharmacists identified 361 incidents, of which 281 (78%) were considered to be an ADE, potential ADE or medication error by reviewers. The incidence of ADEs was 8.5 per 100 admissions (95% confidence interval (CI) 6.8-10.4), with the highest rate found in the intensive care unit (21.1 per 100 admissions) (95% CI 15.1-28.8). Of all ADEs, 59% were rated as significant, 35% as serious and 6% as life threatening. Thirty percent of ADEs were preventable and 96% of these occurred in the ordering stage. The incidence of potential ADEs was 13.8 per 100 admissions (95% CI 11.5-16.2). Overall, 223 medication errors were identified, 66 (30%) were harmless, 132 (59%) had the potential to cause harm and 25 (11%) resulted in harm. CONCLUSIONS The incidence of ADEs in a Saudi Hospital was 8.5 per 100 admissions. Preventable ADEs most commonly occurred in the ordering stage; therefore, interventions to reduce ADEs should target the ordering stage.

Sodium oxybate for narcolepsy with cataplexy: systematic review and meta-analysis.

STUDY OBJECTIVES To assess the efficacy and safety of sodium oxybate (SXB) in narcolepsy-cataplexy patients. DESIGN Systematic review and meta-analysis. PATIENTS Adults with narcolepsy-cataplexy. INTERVENTIONS SXB. MEASUREMENTS AND RESULTS Electronic databases (e.g., MEDLINE) and references of included studies were searched to identify randomized controlled trials (RCTs) assessing the efficacy and safety of SXB for patients with narcolepsy-cataplexy. Risk of bias was appraised using the Cochrane risk of bias tool. Meta-analysis was conducted in Review Manager Version 5. Six RCTs and 5 companion reports were included after screening 14 full-text articles and 483 citations. All were private-industry funded. SXB (usually 9 g/night) was superior to placebo for reducing mean weekly cataplexy attacks (n = 2 RCTs, mean difference [MD]: -8.5, 95% CI: -15.3, -1.6), increasing maintenance wakefulness test (MWT) (n = 2, MD: 5.18, 95% CI: 2.59-7.78), reducing sleep attacks (n = 2, MD: -9.65, 95% CI: -17.72, -1.59), and increasing Clinical Global Impression scores (n = 3, relative risk, RR: 2.42, 95% CI: 1.77-3.32). SXB did not significantly increase REM sleep versus placebo (n = 2, MD: -0.49, 95% CI: -3.90, 2.92). Patients receiving SXB had statistically more adverse events versus placebo, including nausea (n = 3, relative risk [RR]: 7.74, 95% CI: 3.2, 19.2), vomiting (n = 2, RR: 11.8, 95% CI: 1.6, 89.4), and dizziness (n = 3, RR: 4.3, 95% CI: 1.1, 16.4). Enuresis was not significantly different from placebo (n = 2, RR: 2.6, 95% CI: 0.8, 9.8). All meta-analyses had minimal statistical heterogeneity (p-value > 0.1). CONCLUSION Narcolepsy patients on SXB have significant reductions in cataplexy and daytime sleepiness. SXB is well tolerated in patients with narcolepsy, and most adverse events were mild to moderate in severity.

Pattern of Intravenous Proton Pump Inhibitors Use in ICU and Non-ICU Setting: A Prospective Observational Study

Background/Aim: The use of intravenous acid-suppressive therapy for stress ulcer prophylaxis in critically ill patients with specific risk factors has been recommended for over a decade. However, there is a lack of supporting data regarding the extension of such therapy to non-critically ill patients (non-ICU). The aim of this study was to compare appropriate indications with current practicing patterns in adult non-ICU and ICU patients, contributing factors and financial impact of inappropriate use. Materials and Methods: A prospective cross-sectional study was carried out at a tertiary teaching Hospital in Riyadh, Saudi Arabia. For a period of 4 consecutive months, all hospitalized patients on IV PPI, aged 18 and above, were identified. A concise listing of indications considered appropriate for the use of IV PPI was pre-defined based on material from available literature and guidelines. Results: A total of 255 patients received IV PPI. Inappropriate use of IV PPI was significantly higher in non-ICU (71.7%) than in ICU (19.8%) patients (P=0.01). The most common cause for inappropriate use in non-ICU patients was stress ulcer prophylaxis (SUP). In ICU patients, appropriate indicators for IV PPI were SUP (47.9%), PUD (11.5%), and the UGIB (20.8%). There was a high association between appropriate uses of IV PPI with respect to endoscopic procedure and also between appropriate uses of IV PPI to subsequent discharge with oral PPI in non ICU patients. The total estimated direct cost (drug acquisition cost) for inappropriate use of IV PPI during the study period was 11,000 US dollars. Conclusion: Inappropriate IV PPI utilization was predominant in non-ICU patients, mostly for stress ulcer prophylaxis that leads to a waste of resources. Applying appropriate policies, procedures and evidence-based guidelines, educated physicians and surgeons can clearly limit inappropriate IV PPI use.

Medication error reporting in a university teaching hospital in Saudi Arabia.

Objectives Medication errors are common in the hospital setting. Little is known about these errors in Saudi Arabia. The objective of the current study was to explore the rate of reporting medication errors and factors associated with the root causes of these errors in a large tertiary teaching hospital in Saudi Arabia. Methods This study was conducted at the university teaching hospital in Riyadh, Saudi Arabia. All occurrence/variant reports related to medication errors were documented on a hospital Web-based medication error form that was designed to capture information on all aspects. Medication error reports were reviewed and reported at quarterly intervals over a 1-year period (November 2009 to October 2010). Results The medication error rate over the 1-year study period was 0.4% (949 medication errors for 240,000 prescriptions). During this period, 14 (1.5%) errors were categorized as resulting in any harm to the patient (all category E). Medication errors were reported predominantly at the prescribing stage of the medication process (89%). The most common types of errors were prescribing (44%) and improper dose/quantity (31%). Antibiotics (12%), antihypertensive agents (10%), and oral hypoglycemic agents (8%) were the pharmacological classes of medication most commonly involved with errors. Nonspecific performance deficit (43%), knowledge deficit (28%), and illegible or unclear handwriting (17%) were the main reported causes of error. Conclusions Medication errors are underreported in a tertiary teaching hospital in Riyadh, Saudi Arabia. Future studies should evaluate the effectiveness of interventions to stimulate medication errors reporting by health-care providers.

Incidence of adverse drug events in public and private hospitals in Riyadh, Saudi Arabia: the (ADESA) prospective cohort study

Objectives To determine the incidence of adverse drug events (ADEs) and assess their severity and preventability in four Saudi hospitals. Design Prospective cohort study. Setting The study included patients admitted to medical, surgical and intensive care units (ICUs) of four hospitals in Saudi Arabia. These hospitals include a 900-bed tertiary teaching hospital, a 400-bed private hospital, a 1400-bed large government hospital and a 350-bed small government hospital. Participants All patients (≥12 years) admitted to the study units over 4 months. Primary and secondary outcome measures Incidents were collected by pharmacists and reviewed by independent clinicians. Reviewers classified the identified incidents as ADEs, potential ADEs (PADEs) or medication errors and then determined their severity and preventability. Results We followed 4041 patients from admission to discharge. Of these, 3985 patients had complete data for analysis. The mean±SD age of patients in the analysed cohort was 43.4±19.0 years. A total of 1676 ADEs were identified by pharmacists during the medical chart review. Clinician reviewers accepted 1531 (91.4%) of the incidents identified by the pharmacists (245 ADEs, 677 PADEs and 609 medication errors with low risk of causing harm). The incidence of ADEs was 6.1 (95% CI 5.4 to 6.9) per 100 admissions and 7.9 (95% CI 6.9 to 8.9) per 1000 patient-days. The occurrence of ADEs was most common in ICUs (149 (60.8%)) followed by medical (67 (27.3%)) and surgical (29 (11.8%)) units. In terms of severity, 129 (52.7%) of the ADEs were significant, 91 (37.1%) were serious, 22 (9%) were life-threatening and three (1.2%) were fatal. Conclusions We found that ADEs were common in Saudi hospitals, especially in ICUs, causing significant morbidity and mortality. Future studies should focus on investigating the root causes of ADEs at the prescribing stage, and development and testing of interventions to minimise harm from medications.

Antidepressant use, serotonin transporter affinity, and reinfarction among patients receiving clopidogrel: a population-based study.

Conflicting evidence exists regarding the association between antidepressant use and reinfarction among high‐risk cardiovascular patients. Recent evidence suggests that clinical benefit associated with antidepressants may be related to serotonergic activity, suggesting that some antidepressants may offer greater advantages than others.

Cardiovascular risk and fruit and vegetable consumption among women in KSA; A cross-sectional study

Objectives This study aims to assess fruit and vegetable consumption among Saudi women to identify perceived benefits and barriers associated with a healthy diet in cardiovascular disease (CVD) risk prevention and to correlate Framingham risk scores (FRSs) with the perceived barriers. Methods A questionnaire adapted from the Health Beliefs Related to Cardiovascular Disease Scale was administered to women attending a primary care centre in KSA. In addition to descriptive statistics, a chi-square test and multiple linear regression analysis were used to determine the association between perceptions of benefit and barriers with FRS categories and between mean FRS and perceived barriers. Results A total of 503 women were included in this study, and 75% of the women were older than 45 years. More than 60% of women were obese, and 97% consumed 1–3 fruit and vegetable servings per day, whereas only 1.4% consumed fruits and vegetables 5 or more times per day. The majority of women were aware of the benefits of a healthy diet in CVD prevention. No significant difference between FRS and perceived benefits or barriers was observed. Barriers across the low- to high-risk groups included a lack of knowledge about a ‘healthy diet’, insufficient time to cook, food affordability, and having more important problems. Women who disagreed on barriers had negative beta coefficients for the mean FRS (p < 0.03). Conclusions In this study cohort, fruit and vegetable intake was lower than the recommended guidelines. Despite awareness of the benefits of a healthy diet in CVD prevention, very few women understood the true meaning of ‘healthy diet’. A direct association between FRS and perceptions/barriers could not be validated. Perceived barriers could be addressed by integrating innovative educational campaigns to existing models of the Healthy Food Plan.