Mansour A. Mahmoud

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.

Self-medication in Central Saudi Arabia. Community pharmacy consumers’ perspectives

Objectives: To determine the prevalence of self-medication and assess the knowledge, attitudes, and perception of consumers toward self-medication. Methods: This cross-sectional survey was conducted over 4 weeks in May 2011 in Riyadh city, Kingdom of Saudi Arabia. Community pharmacies within 5 areas of the city (North, South, West, East, and Middle) were randomly selected for the study. All consumers were approached to participate in the study, with the exception of those buying cosmetic and medicinal equipments. A validated self-administered questionnaire was used to collect the data. Results: A total of 538 out of 707 consumers attending community pharmacies in Riyadh city, agreed to participate in the study. Most responders were male (73%), 23-33 years old (35%), and college graduates (42%). A total of 285 medications were bought without a prescription. Of these, 149 (49%) medications should be dispensed by prescription only, and 155 (51%) were over the counter medications. The most common prescription medications dispensed without prescriptions were antibiotics (22%) and analgesics/antipyretics (19%). The most common reasons for buying medications without a prescription were that the symptoms were too minor to visit a doctor (54%), time saving (40%), and minor illnesses for which the participants knew the required treatment (40%). Overall, most participants had poor knowledge, and negative perceptions regarding self-medication. More than 68% of participants did not know whether the medicine they bought is a prescription-only or over the counter medication. Conclusion: Irresponsible self-medication is common in Saudi Arabia. Future studies should focus on improving the consumers’ awareness of self-medication and the proper use of medications.

The outcome of pharmacist counseling at the time of hospital discharge: an observational nonrandomized study

BACKGROUND AND OBJECTIVES Adverse drug events (ADEs) may occur after discharge from acute care hospitalization because of limited instruction on medications at discharge. The right instructions given to patients may reduce the risk of ADEs. The objective of our study was to assess a program involving comprehensive medication counseling provided by pharmacists at the time of discharge from a tertiary hospital in Riyadh, Saudi Arabia. DESIGN AND SETTING A prospective, nonrandomized observational study over a period of 3 months in a 1000-bed tertiary hospital. PATIENTS AND METHODS Patients discharged from the internal medicine wards with more than three medications received comprehensive pharmacist counseling. The intervention pharmacist counseled patients about their discharge medications and provided written materials as needed. Topics discussed with the patients included the importance of following prescribed medication regimens and the indications, directions, and any potential side effects of discharge medications. The control group included similar patients who received routine discharge counseling by nurses. Two weeks after discharge, the same pharmacist called the patients and assessed the frequency of ADEs. Two independent clinicians reviewed each ADEs and judged its severity and preventability. RESULTS Out of 200 patients included in the study (100 patients from the intervention group and 100 patients from the control group), 175 patients (87.5%) were successfully contacted two weeks after discharge (88 patients from the intervention group and 87 patients from the control group). ADEs occurred in 2 patients (2.3%) in the intervention group and in 21 patients (24%; 23 incidents in 21 patients) in the control group (P<.001). In the control group, 14 ADEs (61%) were judged as preventable, and 9 (39%) were judged as serious. CONCLUSIONS A comprehensive medication counseling program at hospital discharge reduced the incidence of ADEs two weeks after discharge from a tertiary hospital in Riyadh, Saudi Arabia. Further studies assessing the long-term outcomes of such a program are needed.

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.

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.

Implementation of safety standards of compounded sterile preparations in hospital pharmacies: a multinational cross-sectional study

Objectives To evaluate implementation of safety standards of compounded sterile preparations in different hospitals. Methods This cross-sectional study included 124 hospitals from 19 countries. A survey was developed based on the guidelines and safety practices of the Institute for Safe Medication Practices (ISMP) for sterile preparations compounding, and was sent to the members of the Intravenous and Parenteral Nutrition experts’ network (IV PN experts’ network) in the Gulf region and beyond using SurveyMonkey software. Results 124 pharmacists were invited to participate in this study. Only 39 (31.5%) pharmacists from seven countries responded: 16 (41%) of the participants were pharmacy supervisors, and 23 (59%) had >10 years of work experience. However, a majority, 27 (69%), of the respondents were from Saudi Arabia. Written policies and procedures for sterile preparations compounding were available in 37 (95%) hospitals. The concentrated electrolytes were removed from all patient care areas in 28 (72%) hospitals, and 30 (77%) hospitals clearly labelled those as high-alert medications. The use of advanced technologies, such as bar code verification or IV robotics, for compounding sterile preparations were not implemented in 27 (69%) hospitals. Conclusions Minimum standards and best practice recommendations to ensure safety of sterile preparation compounding were implemented in many hospitals of different countries. However, advanced technologies were not implemented by the majority of the hospitals.

Prescribing errors incidence in hospitalized Saudi patients: Methodology considerations

Medication errors are the leading cause of adverse drug events (ADEs) and most commonly occur in the prescribing stage (Bates et al., 1995; Aljadhey et al., 2013). A systematic review of 65 studies that investigated the prevalence and incidence of prescribing errors conducted in 2009 in the UK concluded that prescribing errors occur in 7% of medication orders, 2% of patient days and 50% of hospital admissions (Lewis et al., 2009). In Saudi Arabia majority of the studies conducted to investigate prescribing errors came from the primary care settings. However, hospitalized patients received little attention. A recent study conducted for two months in the inpatient medical wards of a teaching hospital in Riyadh city found an incidence of 7.7% prescribing errors in 1582 written medication orders, with the wrong strength and wrong drug administration frequency accounting for the most common type of errors identified (Al-Dhawailie, 2011). A prescribing error in this study was defined as wrong drug, wrong dose, wrong strength, wrong frequency and wrong drug combination. This study provided an example of the severity of the prescribing errors, however how the author concludes that, was not clearly defined. Other investigators conducted a study to identify prescribing errors in the general pediatric wards and a pediatric intensive care unit of a tertiary hospital (Al-Jeraisy et al. (2011)). A prescription error in this study was defined as; incorrect or inappropriate drug selection, dose, route, rate of administration, or frequency. Prescription errors also include; illegible handwriting, an incomplete order (missing the dose, route, or frequency), incompatibility, incorrect instructions for using the drug product, and the use of non-standard nomenclature or abbreviations, that requires further interpretation. Investigators reviewed 2380 medication orders and identified 56 prescribing errors per 100 medication orders (95% CI: 54.2%, 57.8%) and the majority of these errors (79%) were classified as potentially harmful. However, the contexts based on which the severity of these errors was defined were also not clearly defined. There are obvious variations in the definitions and methods used to detect these errors, and hence there is remarkable variability in the reported incidence. These variations may also reflect the quality of the particular healthcare settings. To our knowledge the previously mentioned two studies are the only published studies that investigated the in hospital incidence of prescribing errors in Saudi Arabia and therefore their finding is only a snapshot of a specific ward within a single hospital in the country. Therefore; the results of these studies are not generalizable. In the systematic review conducted by Lewis et al. (2009), most of the studies that investigated prescribing errors have either used their own definitions based on the commonly known types of medication errors, or have used a standard and validated definition that was developed by Dean et al., (2000), who defined prescribing errors as; “A clinically meaningful prescribing error occurs when, as a result of a prescribing decision or prescription writing process, there is an unintentional significant (1) reduction in the probability of treatment being timely and effective or (2) increase in the risk of harm when compared with generally accepted practice”. This definition was also accompanied with different scenarios that represent prescribing errors. However, other investigators argued that it is also important to include insignificant prescribing errors that did not cause harm, because it might cause harm in the future (Jeffrey, 2009). In Saudi Arabia, a large study at a national level from different hospitals that uses a standard and validated definition of prescribing errors is needed. The use of a pre-validated definition is strongly supported to allow comparison of data between studies from different parts of the world that use the same methodology. Perhaps if we utilize the widely used and previously validated definition and scenarios that represent prescribing errors (Dean et al., 2000), revalidation of the tool in the context of Saudi Arabia might be an essential step. This will help in getting generalizable results and will also help when comparing our local data with international studies that had used similar definitions.

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010–2015

Purpose To analyze and compare the signals of bleeding from the use of direct-acting oral anticoagulants (DOACs) in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database over 5 years. Methods Reports of bleeding and of events with related terms submitted to the FAERS between October 2010 and September 2015 were retrieved and then analyzed using the reporting odds ratio (ROR). The signals of bleeding associated with DOAC use were compared with the signals of bleeding associated with warfarin use utilizing the FAERS databases. Results A total of 1,518 reports linked dabigatran to bleeding, accounting for 2.7% of all dabigatran-related reports, whereas 93 reports linked rivaroxaban to bleeding, which accounted for 4.4% of all rivaroxaban-related reports. The concurrent proportion of bleeding-related reports for warfarin was 3.6%, with a total of 654 reports. The association of bleeding and of related terms with the use of all three medications was significant, albeit with different degrees of association. The ROR was 12.30 (95% confidence interval [CI] 11.65–12.97) for dabigatran, 15.61 (95% CI 14.42–16.90) for warfarin, and 18.86 (95% CI 15.31–23.23) for rivaroxaban. Conclusions The signals of bleeding varied among the DOACs, and the bleeding signal was higher for rivaroxaban and lower for dabigatran compared to that for warfarin.

What is the epidemiology of medication errors, error-related adverse events and risk factors for errors in adults managed in community care contexts? A systematic review of the international literature

Objective To investigate the epidemiology of medication errors and error-related adverse events in adults in primary care, ambulatory care and patients’ homes. Design Systematic review. Data source Six international databases were searched for publications between 1 January 2006 and 31 December 2015. Data extraction and analysis Two researchers independently extracted data from eligible studies and assessed the quality of these using established instruments. Synthesis of data was informed by an appreciation of the medicines’ management process and the conceptual framework from the International Classification for Patient Safety. Results 60 studies met the inclusion criteria, of which 53 studies focused on medication errors, 3 on error-related adverse events and 4 on risk factors only. The prevalence of prescribing errors was reported in 46 studies: prevalence estimates ranged widely from 2% to 94%. Inappropriate prescribing was the most common type of error reported. Only one study reported the prevalence of monitoring errors, finding that incomplete therapeutic/safety laboratory-test monitoring occurred in 73% of patients. The incidence of preventable adverse drug events (ADEs) was estimated as 15/1000 person-years, the prevalence of drug–drug interaction-related adverse drug reactions as 7% and the prevalence of preventable ADE as 0.4%. A number of patient, healthcare professional and medication-related risk factors were identified, including the number of medications used by the patient, increased patient age, the number of comorbidities, use of anticoagulants, cases where more than one physician was involved in patients’ care and care being provided by family physicians/general practitioners. Conclusion A very wide variation in the medication error and error-related adverse events rates is reported in the studies, this reflecting heterogeneity in the populations studied, study designs employed and outcomes evaluated. This review has identified important limitations and discrepancies in the methodologies used and gaps in the literature on the epidemiology and outcomes of medication errors in community settings.

Corrigendum to “Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia” [Saudi Pharm. J. 22(5) (2014) 411–418]

[This corrects the article DOI: 10.1016/j.jsps.2013.07.005.].