ObjectiveTo investigate the epidemiology of medication errors and error-related adverse events in adults in primary care, ambulatory care and patients’ homes.DesignSystematic review.Data sourceSix international databases were searched for publications between 1 January 2006 and 31 December 2015.Data extraction and analysisTwo 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.Results60 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.ConclusionA 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.
The majority of community pharmacists in Riyadh have poor knowledge of the ADR reporting process. Pharmacovigilance authorities should take necessary steps to urgently design interventional programs in order to increase the knowledge and awareness of pharmacists regarding the ADR reporting process.
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.
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.
Healthcare professionals have identified major challenges and opportunities for medication safety in Saudi Arabia. Policy makers and practitioners should consider these factors when designing future programs aimed at improving the safe use of medications.
ObjectivesTo determine the incidence of adverse drug events (ADEs) and assess their severity and preventability in four Saudi hospitals.DesignProspective cohort study.SettingThe 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.ParticipantsAll patients (≥12 years) admitted to the study units over 4 months.Primary and secondary outcome measuresIncidents 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.ResultsWe 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.ConclusionsWe 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.
Purpose: To assess the general public awareness and perception about Adverse Drug Reactions (ADRs) reporting and pharmacovigilance. Method: A cross-sectional study conducted on June 2012 during awareness campaign held in two malls in Riyadh city for two days. A self-administered questionnaire consisting of three parts was distributed to the attendees who accepted to participate in the study. Results: A total of 204 questionnaires were collected with a response rate of 68%. Twenty-three percent could correctly define ADRs. Only 13(15.7%) of responders were familiar with the term “Pharmacovigilance” and only 78.6% were aware about the Saudi Pharmacovigilance Center. Sixty-seventy percent indicated that their physicians or pharmacists don't actively encourage them to report ADRs that may occur when they take their medications. The majority of responders (73.2%) believed that the medical team, rather than consumers, should report ADRs. When asked why patients do not report ADRs, 19.1(48.5%) believed that patients do not know whether the ADR is from the medication or not, 18.1(46.1%) stated that the reason was because patients don't know about the Pharmacovigilance Center, 16(40.7%) think that patients don't know about the importance of ADRs reporting, and 14(36.3%) responded that patients probably don't know how to report ADRs. Conclusion: The general public in Saudi Arabia are not aware about ADRs reporting and the pharmacovigilance system. The Saudi Food and Drug Authorities (FDA) need to put more efforts to increasing public awareness about the importance of ADRs reporting process and the importance of pharmacovigilance system in promoting patient safety.
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