Ahmed Y. Mayet

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.

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.

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.

Hospital pharmacy practice in Saudi Arabia: Drug monitoring and patient education in the Riyadh region

BACKGROUND The purpose of this national survey is to evaluate hospital pharmacy practice in the Riyadh region of Saudi Arabia. The results of the survey pertaining to the monitoring and patient education of the medication use process were presented. METHODS We have invited pharmacy directors from all 48 hospitals in the Riyadh region to participate in a modified-American Society of Health-System Pharmacists (ASHP) survey questionnaire. The survey was conducted using similar methods to those of the ASHP surveys. RESULTS The response rate was 60.4% (29/48). Most hospitals (23, 79%) had pharmacists regularly monitor medication therapy for patients. Of these hospitals, 61% had pharmacists monitoring medication therapy daily for less than 26% of patients, 17% monitored 26-50% of patients and 22% monitored more than half of patients daily. In 41% of hospitals, pharmacists routinely monitored serum medication concentrations or their surrogate markers; 27% gave pharmacists the authority to order initial serum medication concentrations, and 40% allowed pharmacists to adjust dosages. Pharmacists routinely documented their medication therapy monitoring activities in 52% of hospitals. Overall, 74% of hospitals had an adverse drug event (ADE) reporting system, 59% had a multidisciplinary committee responsible for reviewing ADEs, and 63% had a medication safety committee. Complete electronic medical record (EMR) systems were available in 15% of hospitals and 81% had a partial EMR system. The primary responsibility for performing patient medication education lays with nursing (37%), pharmacy (37%), or was a shared responsibility (26%). In 44% of hospitals, pharmacists provided medication education to half or more inpatients and in a third of hospitals, pharmacists gave medication education to 26% or more of patients at discharge. CONCLUSION Hospital pharmacists in the Riyadh region are actively engaged in monitoring medication therapy and providing patient medication education, although there is considerable opportunity for further involvement.

Genotype-phenotype analysis of CYP2C19 in healthy saudi individuals and its potential clinical implication in drug therapy.

CYP2C19 is a cytochrome P450 enzyme, which is involved in the metabolism of some clinically important medications and is encoded by a highly polymorphic gene. There is no available data on the distribution of the CYP2C19 *4 and *17 mutant alleles in the Saudi Arabian population. The aim of the study was to determine different CYP2C19 mutant allele (*2, *4 and *17) frequencies in healthy Saudi subjects and to determine genotype frequencies for these mutations. The CYP2C19 genotypes were then classified into phenotypes. Result: In 201 adults of Saudi ethnicity, the allele frequencies were CYP2C19*1 (62.9%), *17 (25.7%), *2 (11.2%) and *4 (0.2%). The most prevalent genotype combinations were CYP2C19 *1/*1 (40.3%) and *1/*17 (30.4%). The distribution of CYP2C19 phenotypes was divided into extensive metabolizers (EM) 77.6%, intermediate metabolizers (IM) 14.9%, ultra-rapid metabolizers (UM) 7% and poor metabolizers (PM) 0.4%. This finding has important clinical implications for the use of CYP2C19 metabolized medications in the Saudi population and further studies are needed.

Knowledge, attitudes, beliefs, and barriers associated with the uptake of influenza vaccine among pregnant women

Objective: The purpose of the study was to assess the knowledge, attitudes, beliefs, and factors associated with the uptake of the influenza (flu) vaccination in women within Saudi Arabia during their pregnancy period. Methods: A cross-sectional prospective survey was conducted on 1085 pregnant women at the antenatal clinic over a period of 6 weeks with the provision of influenza vaccination. The questionnaire collected demographic and other data; it included 12 questions on their general knowledge and assessed their attitude toward influenza vaccination, and their awareness of vaccine risk and the potential benefits during pregnancy. The knowledge score obtained was then calculated and compared. Results: A total of 998 patients took part in the questionnaire with a response rate of 92%. There was poor awareness that the flu vaccine is safe to administer during pregnancy (130, 13.1%) and that all pregnant women should receive the flu vaccine (190, 19.1%). Pregnant women with flu vaccine knowledge score of ⩽5 (range 0–12) were significantly less likely to take the vaccine (OR 3.78, 95% CI 2.68–5.26, p < 0.001). There was a low uptake of the vaccine (178, 18.1%) and only 29 (3.0%) had previously been offered the flu vaccine by any doctor during their pregnancy. In addition, 255 (25.8%) were against taking the flu vaccine during pregnancy. Conclusion: The knowledge and uptake of the influenza vaccine among Saudi pregnant women are low. One quarter was against the vaccine during pregnancy. Very few believed the flu vaccine to be safe during pregnancy. Rarely, physicians advise their clients to take flu vaccine.

Patient adherence to warfarin therapy and its impact on anticoagulation control.

Warfarin is a commonly prescribed oral anticoagulant in Saudi Arabia and yet patient adherence to warfarin therapy and its impact on anticoagulation control have not been well researched here. A cross-sectional survey was conducted over 6 weeks at the outpatient anticoagulant clinic on patients who were receiving warfarin. Adherence was assessed using the translated Arabic version of the Morisky Medication Adherence Scale (MMAS-8). Levels of adherence were classed as low (score ⩽ 7), or high (score = 8) based on the scores. Good anticoagulation control was defined as percent Time INR in Therapeutic Range (TTR) ⩾ 75% using the Rosendaal method. A total of 192 patients completed a questionnaire with a response rate of 68.1%. It was established that no association was found between adherence to warfarin therapy and INR control groups. Among the 89 (46.4%) patients who had high adherence, only 34 (38.2%) had an acceptable INR control. This was versus 103 (53.6%) patients who had low adherence but also 34 (33.0%) had good INR control. Multivariate logistic regression (MLR) analysis showed that when studying females and occupational status of unemployment, they were independently associated with poor INR control with an OR 2.31, 95% CI 1.10–4.92, and OR 2.71, 95% CI 1.12–6.61 respectively. MLR analysis also showed that age <50 years alongside no formal education was independently associated with low adherence to warfarin therapy with an OR 2.67, 95% CI 1.29–5.52 and OR 2.63, 95% CI 1.01–6.93 respectively. The demographic background influences adherence and INR control, but no association was found between adherence and anticoagulation control.

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

PURPOSE The purpose of this survey is to outline pharmacy services in hospitals on a regional level in the Kingdom of Saudi Arabia. METHODS A 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 surveys purpose, the questionnaires were personally delivered and collected upon completion. The hospital lists were drawn from the Ministry of Health hospital database. RESULTS Twenty-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. CONCLUSION Hospital pharmacists are increasingly using electronic technologies to improve prescribing and transcribing of medications in Saudi Arabia.

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.