Effect of warning symbols in combination with education on the frequency of erroneously crushing medication in nursing homes: an uncontrolled before and after study.

OBJECTIVES: Residents of nursing homes often have difficulty swallowing (dysphagia), which complicates the administration of solid oral dosage formulations. Erroneously crushing medication is common, but few interventions have been tested to improve medication safety. Therefore, we evaluated the effect of warning symbols in combination with education on the frequency of erroneously crushing medication in nursing homes. SETTING: This was a prospective uncontrolled intervention study with a preintervention and postintervention measurement. The study was conducted on 18 wards (total of 200 beds) in 3 nursing homes in the North of the Netherlands. PARTICIPANTS: We observed 36 nurses/nursing assistants (92% female; 92% nursing assistants) administering medication to 197 patients (62.9% female; mean age 81.6). INTERVENTION: The intervention consisted of a set of warning symbols printed on each patient's unit dose packaging indicating whether or not a medication could be crushed as well as education of ward staff (lectures, newsletter and poster). PRIMARY OUTCOME MEASURE: The relative risk (RR) of a crushing error occurring in the postintervention period compared to the preintervention period. A crushing error was defined as the crushing of a medication considered unsuitable to be crushed based on standard reference sources. Data were collected using direct (disguised) observation of nurses during drug administration. RESULTS: The crushing error rate decreased from 3.1% (21 wrongly crushed medicines out of 681 administrations) to 0.5% (3/636), RR=0.15 (95% CI 0.05 to 0.51). Likewise, there was a significant reduction using data from patients with swallowing difficulties only, 87.5% (21 errors/24 medications) to 30.0% (3/10) (RR 0.34, 95% CI 0.13 to 0.89). Medications which were erroneously crushed included enteric-coated formulations (eg, omeprazole), medication with regulated release systems (eg, Persantin; dipyridamol) and toxic substances (eg, finasteride). CONCLUSIONS: Warning symbols combined with education reduced erroneous crushing of medication, a well-known and common problem in nursing homes.

Discontinuing inappropriate medication in nursing home residents (DIM-NHR Study): protocol of a cluster randomised controlled trial.

INTRODUCTION: Nursing home residents often have a high number of comorbidities resulting in polypharmacy. Inappropriate prescribing is therefore likely to occur, which in turn is expected to worsen cognitive impairment, to increase the fall risk and to decrease residents' quality of life. The objective of the 'Discontinuing Inappropriate Medication in Nursing Home Residents' (DIM-NHR) study is to examine the efficacy and cost-effectiveness of the Multidisciplinary Multistep Medication Review (3MR) that is aimed at optimising prescribing and discontinuing inappropriate medication. METHODS: A cluster randomised controlled trial will be conducted. Elderly care physicians and their wards (clusters) will be randomised. Data will be collected at baseline and 4 months after the 3MR has taken place. Six hundred nursing home residents will be recruited of whom more than half are expected to suffer from dementia. The 3MR will be based on consensus criteria and the relevant literature and will be performed by the patient's elderly care physician in collaboration with a pharmacist. ANALYSIS: Primary outcomes-the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up. Secondary outcomes-undertreatment, exposure to anticholinergic and sedative medicines, neuropsychiatric symptoms, cognitive function, falls, hospital admission, quality of life and cost-effectiveness. ETHICS AND DISSEMINATION: Participant burden will be kept at a minimum. The elderly care physician will remain free to adjust medication when symptoms relapse or adverse events occur, rendering serious adverse events highly unlikely. Study findings will be published in peer-reviewed journals and a 3MR toolkit will be developed. TRIAL REGISTRATION NUMBER: This study has been registered at http://www.ClinicalTrials.gov (trial registration number: NCT01876095).

Preventable and non-preventable adverse drug events in hospitalized patients: a prospective chart review in the Netherlands.

BACKGROUND: Medication safety research and clinical pharmacy practice today is primarily focused on managing preventable adverse drug events (pADEs). Determinants of both pADEs and non-preventable adverse drug reactions (ADRs) have been identified. However, relatively little is known on the overlap between these determinants and the balance of preventable and non-preventable harm inpatients experience in modern computerized hospitals. OBJECTIVE: The aim of this study was to analyse the prevalence of pADEs and non-preventable ADRs as well as the determinants, including multimorbidity, of these ADEs, i.e. both pADEs and ADRs. METHODS: Adverse events experienced by patients admitted to two Dutch hospitals with functioning computerized physician order entry (CPOE) systems were prospectively identified through chart review. Adverse events were divided into pADEs (i.e. as a result of a medication error) and non-preventable ADRs. In both cases, a causal relationship between adverse events and patients' drugs was established using the simplified Yale algorithm. Study data were collected anytime between April 2006 and May 2008 over a 5-month period at each hospital ward included in the study, beginning from 8 weeks after CPOE was implemented at the ward. RESULTS: pADEs and non-preventable ADRs were experienced by 349 (58%) patients, of whom 307 (88%) had non-preventable ADRs. Multimorbidity (adjusted odds ratio [OR(adj)] 1.90; 95% CI 1.44, 2.50; OR(adj) 1.28; 95% CI 1.14, 1.45, respectively), length of stay (OR(adj) 1.13; 95% CI 1.06, 1.21; OR(adj) 1.11; 95% CI 1.07, 1.16, respectively), admission to the geriatric ward (OR(adj) 7.78; 95% CI 2.15, 28.13; OR(adj) 3.82; 95% CI 1.73, 8.45, respectively) and number of medication orders (OR(adj) 1.25; 95% CI 1.16, 1.35; OR(adj) 1.13; 95% CI 1.06, 1.21, respectively) were statistically significantly associated with pADEs and ADRs. Admission to the gastroenterology/rheumatology ward (OR(adj) 0.22; 95% CI 0.06, 0.77; OR(adj) 0.40; 95% CI 0.24, 0.65, respectively) was inversely related to both pADEs and ADRs. Other determinants for ADRs only were female sex (OR(adj) 1.77; 95% CI 1.12, 2.80) and use of drugs affecting the nervous system (OR(adj) 1.83; 95% CI 1.09, 3.07). Age was a significant determinant for pADEs only (OR(adj) 1.07; 95% CI 1.03, 1.11). CONCLUSIONS: In this study more than half of the patients admitted to the hospitals are harmed by drugs, of which most are non-serious, non-preventable ADRs (after the introduction of CPOE). Determinants of both pADEs and ADRs overlap to a large extent. Our results imply the need for signalling early potential adverse events that occur during the normal use of drugs in multimorbid patients or those in geriatric wards. Subsequent therapeutic interventions may improve the well-being of hospitalized patients to a greater extent than focusing on errors in the medication process only.

Comparison of potential risk factors for medication errors with and without patient harm.

PURPOSE: To compare determinants for medication errors leading to patient harm with determinants for medication errors without patient harm. METHODS: A two-way case-control design was used to identify determinants for medication errors without harm (substudy 1) and determinants for medication errors causing harm (substudy 2). Data of patients admitted to five internal medicine wards of two Dutch hospitals during 5 months were collected prospectively by chart review. Medication errors were detected and classified by two pharmacists. Consensus between five pharmacists was reached on the causal relationship between medication errors and patient harm. Data analysis was performed by multivariate logistic regression. RESULTS: We included 7286 medication orders, of which 3315 without errors (controls), and 5622 medication errors without harm (cases substudy 1) and 102 medication errors causing harm (cases substudy 2) were identified. Hospital, ward and the therapeutic class anti-infectives were associated with both medication errors without harm (hospital odds ratio (OR) 1.40; 95% confidence interval (CI) 1.21-1.63), TweeSteden hospital (TSh) geriatrics OR 2.03; 95% CI 1.73-2.38, TSh general internal medicine OR 1.44; 95% CI 1.23-1.69 and anti-infectives OR 1.28; 95% CI 1.06-1.56) and medication errors with harm (hospital OR 4.91; 95% CI 3.02-7.79, TSh geriatrics OR 5.76; 95% CI 2.52-13.15, TSh general internal medicine OR 6.51; 95% CI 2.82-15.02 and anti-infectives OR 4.20; 95% CI 2.24-7.90). CONCLUSIONS: This study shows that organisational determinants (hospital, ward) are comparable for medication errors with and without harm. For conclusions on patient- and medication-related determinants studies with larger sample sizes are needed.

Comparison of methods for identifying patients at risk of medication-related harm.

BACKGROUND: With the introduction of Computerised Physician Order Entry (CPOE) in routine hospital care, a great deal of effort has been put into refining Clinical Decision Support Systems (CDSS) to identify patients at risk of preventable medication-related harm. OBJECTIVES: This study compared a CPOE with basic CDSS and 16 clinical rules with a manual pharmacist medication review to detect overdose and drug-drug interactions that actually required a change in medication. METHODS: The study involved the review of 313 patients admitted over 5 months at an internal medicine ward where a change in medication as a result of dosing of therapeutic errors was detected by a manual medication review by a trained pharmacist. Subsequently, all these patients' medication orders (MOs) were entered into the authors' CPOE with basic CDSS. Medication orders with a safety alert indicating overdose and drug-drug interactions generated by the authors' CPOE with basic CDSS were compared with the same type of medication errors identified through manual review. The positive predictive value (PPV), sensitivity and specificity compared with manual review were determined. Second, a set of 16 clinical rules was applied to the patient and prescribing data. The overlap between the clinical rules and manual review was determined by comparing patients triggered by the clinical rule with patients with a corresponding error in the manual medication review. RESULTS: Manual medication review identified 57 medication errors involving overdose and 143 therapeutic errors of which 46 were drug-drug interactions. The CPOE with basic CDDS generated 297 safety alerts involving overdose (PPV 0.06, sensitivity 0.32, specificity 0.92) and 365 safety alerts involving drug-drug interactions (PPV 0.12, sensitivity 0.96, specificity 0.91). The clinical rules generated 313 safety alerts identifying 39% of all the overdoses and therapeutic errors found in the manual review at which they were targeted. In 23% of the alerts generated by a clinical rule, the patients actually required a change of medication as indicated by the manual review. When CPOE with basic CDSS and the rules were combined, 66% of the overdoses and therapeutic errors were identified. CONCLUSIONS: The authors' CPOE with basic CDSS and the clinical rules are useful early strategies for preventing medication-related harm. They could be a first step towards more advanced decision support. These computerised systems will be even more useful in daily practice, once they are further fine-tuned to decrease the number of alerts that need no clinical action.

Computerized physician order entry (CPOE) system: expectations and experiences of users.

OBJECTIVES: To explore physicians' and nurses' expectations before and experiences after the implementation of a computerized physician order entry (CPOE) system in order to give suggestions for future optimization of the system as well as the implementation process. METHOD: On four internal medicine wards of two Dutch hospitals, 18 physicians and 42 nurses were interviewed to measure expectations and experiences with the CPOE system. Using semi-structured questionnaires, expectations and experiences of physicians and nurses with the CPOE system were measured with statements on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). The percentage respondents agreeing (score of 4 or 5) was calculated. Chi-squared tests were used to compare the expectations versus experiences of physicians and nurses and to assess the differences between physicians and nurses. RESULTS: In general, both physicians and nurses were positive about CPOE before and after the implementation of this system. Physicians and nurses did not differ in their views towards CPOE except for the overview of patients' medication use that was not clear according to the nurses. Both professions were satisfied with the implementation process. CPOE could be improved especially with respect to technical aspects (including the medication overview) and decision support on drug-drug interactions. CONCLUSION: Overall we conclude that physicians and nurses are positive about CPOE and the process of its implementation and do accept these systems. However, these systems should be further improved to fit into clinical practice.

The influence that electronic prescribing has on medication errors and preventable adverse drug events: an interrupted time-series study.

OBJECTIVE: This study evaluated the effect of a Computerized Physician Order Entry system with basic Clinical Decision Support (CPOE/CDSS) on the incidence of medication errors (MEs) and preventable adverse drug events (pADEs). DESIGN: Interrupted time-series design. MEASUREMENTS: The primary outcome measurements comprised the percentage of medication orders with one or more MEs and the percentage of patients with one or more pADEs. RESULTS: Pre-implementation, the mean percentage of medication orders containing at least one ME was 55%, whereas this became 17% post-implementation. The introduction of CPOE/CDSS has led to a significant immediate absolute reduction of 40.3% (95% CI: -45.13%; -35.48%) in medication orders with one or more errors. Pre-implementation, the mean percentage of admitted patients experiencing at least one pADE was 15.5%, as opposed to 7.3% post-implementation. However, this decrease could not be attributed to the introduction of CPOE/CDSS: taking into consideration the interrupted time-series design, the immediate change was not significant (-0.42%, 95% CI: -15.52%; 14.68%) because of the observed underlying negative trend during the pre-CPOE period of -4.04% [95% CI: -7.70%; -0.38%] per month. CONCLUSIONS: This study has shown that CPOE/CDSS reduces the incidence of medication errors. However, a direct effect on actual patient harm (pADEs) was not demonstrated.

Reliability of the assessment of preventable adverse drug events in daily clinical practice.

PURPOSE: To determine the reliability of the assessment of preventable adverse drug events (ADEs) in daily practice and to explore the impact of the assessors' professional background and the case characteristics on reliability. METHODS: We used a combination of the simplified Yale algorithm and the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) scheme to assess on the one hand the causal relationship between medication errors (MEs) and adverse events in hospitalised patients and on the other hand the severity of the clinical consequence of MEs. Five pharmacists and five physicians applied this algorithm to 30 potential MEs. After individual assessment, the pharmacists reached consensus and so did the physicians. Outcome was both MEs' severity (ordinal scale, NCC MERP categories A-I) and the occurrence of preventable harm (binary outcome, NCC MERP categories A-D vs. E-I). Kappa statistics was used to assess agreement. RESULTS: The overall agreement on MEs' severity was fair for the pharmacists (kappa = 0.34) as well as for the physicians (kappa = 0.25). Overall agreement for the 10 raters was fair (kappa = 0.25) as well as the agreement between both consensus outcomes (kappa = 0.30). Agreement on the occurrence of preventable harm was higher, ranging from kappa = 0.36 for the physicians through kappa = 0.49 for the pharmacists. Overall agreement for the 10 raters was fair (kappa = 0.36). The agreement between both consensus outcomes was moderate (kappa = 0.47). None of the included case characteristics had a significant impact on agreement. CONCLUSIONS: Individual assessment of preventable ADEs in real patients is difficult, possibly because of the difficult assessment of contextual information. Best approach seems to be a consensus method including both pharmacists and physicians.

Complex pharmaceutical care intervention in pulmonary care: part B. Patient opinion and process survey.

OBJECTIVE: The IPMP study (Interventions on the principle of Pulmonary Medication Profiles) investigates and describes the results of complex pharmaceutical care interventions provided to selected pulmonary patients to improve their drug use. This paper describes the patients' opinions about the care provided and the results of the intervention. METHOD: Questionnaires investigating patients' opinions about provided pharmaceutical care were sent to 185 patients participating in the IPMP study after the intervention by their pharmacists had been finished. One year after the start of the intervention, patients were invited to a final consultation by their pharmacists to evaluate their drug use and their symptoms (n = 138). At this point in time pharmacists investigated the knowledge of the patients about the medication and their inhaler technique again. MAIN OUTCOME MEASURE: The influence of the intervention on patients' symptoms. Change in drug-related problems, knowledge and skills concerning pulmonary medication after intervention. Satisfaction of the patients with the provided pharmaceutical care. RESULTS: In total 141 out of 185 patients completed the questionnaire. Patients were satisfied with the intervention by their pharmacists and considered it important. The majority (67%) reported that they had learned more about their medication or the inhaler technique, resulting in significantly improved coping behaviour with their pulmonary medication compared with patients who valued the intervention as a nice conversation with their pharmacist only. Patients with improved ability to cope reported statistically significantly fewer symptoms compared with patients reporting no change in behaviour (chi-square test, P < 0.05). In the final consultation of 138 patients, pharmacists observed increased knowledge and skills and decreased drug-related problems. The patients concerned were pleased with the change in treatment and were more satisfied with their current medication as compared with their earlier reports. CONCLUSION: Patients can be influenced effectively by the tailored intervention of pharmacists resulting in improved ability to cope with pulmonary medication and in fewer reported adverse effects and symptoms. Patients attributed these results to the intervention of the pharmacists.