Effect of a pharmacist-led multicomponent intervention focussing on the medication monitoring phase to prevent potential adverse drug events in nursing homes

OBJECTIVES: To determine the extent to which the use of a clinical informatics tool that implements prospective monitoring plans reduces the incidence of potential delirium, falls, hospitalizations potentially due to adverse drug events, and mortality.

DESIGN: Randomized cluster trial.

SETTING: Twenty-five nursing homes serviced by two long-term care pharmacies.

PARTICIPANTS: Residents living in nursing homes during 2003 (1,711 in 12 intervention; 1,491 in 13 usual care) and 2004 (1,769 in 12 intervention; 1,552 in 13 usual care).

INTERVENTION: The pharmacy automatically generated Geriatric Risk Assessment MedGuide (GRAM) reports and automated monitoring plans for falls and delirium within 24 hours of admission or as part of the normal time frame of federally mandated drug regimen review.

MEASUREMENTS: Incidence of potential delirium, falls, hospitalizations potentially due to adverse drug events, and mortality.

RESULTS: GRAM triggered monitoring plans for 491 residents. Newly admitted residents in the intervention homes experienced a lower rate of potential delirium onset than those in usual care homes (adjusted hazard ratio (HR)=0.42, 95% confidence interval (CI)=0.35–0.52), overall hospitalization (adjusted HR=0.89, 95% CI=0.72–1.09), and mortality (adjusted HR=0.88, 95% CI=0.66–1.16). In longer stay residents, the effects of the intervention were attenuated, and all estimates included unity.

CONCLUSION: Using health information technology in long-term care pharmacies to identify residents who might benefit from the implementation of prospective medication monitoring care plans when complex medication regimens carry potential risks for falls and delirium may reduce adverse effects associated with appropriate medication use.

Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients

Background: Previous studies have not demonstrated a consistent association between potentially inappropriate medicines (PIMs) in older patients as defined by Beers criteria and avoidable adverse drug events (ADEs). This study aimed to assess whether PIMs defined by new STOPP (Screening Tool of Older Persons’ potentially inappropriate Prescriptions) criteria are significantly associated with ADEs in older people with acute illness.

Methods: We prospectively studied 600 consecutive patients 65 years or older who were admitted with acute illness to a university teaching hospital over a 4-month interval. Potentially inappropriate medicines were defined by both Beers and STOPP criteria. Adverse drug events were defined by World Health Organization–Uppsala Monitoring Centre criteria and verified by a local expert consensus panel, which also assessed whether ADEs were causal or contributory to current hospitalization. Hallas criteria defined ADE avoidability.Wecompared the proportions of patients taking Beers criteria PIMs
and STOPP criteria PIMs with avoidable ADEs that were causal or contributory to admission.

Results: A total of 329 ADEs were detected in 158 of 600 patients (26.3%); 219 of 329 ADEs (66.6%) were considered causal or contributory to admission. Of the 219 ADEs, 151(68.9%)considered causal or contributory to admission were avoidable or potentially avoidable. After adjusting for age, sex, comorbidity, dementia, baseline activities of daily living function, and number of medications, the likelihood of a serious avoidable ADE increased significantly when STOPP PIMs were prescribed (odds ratio, 1.847; 95% confidence interval [CI], 1.506-2.264; P.001); prescription of Beers criteria PIMs did not significantly increase ADE risk (odds ratio, 1.276; 95% CI, 0.945-1.722; P=.11).

Conclusion: STOPP criteria PIMs,unlike Beers criteria PIMs, are significantly associated with avoidable ADEs in older people that cause or contribute to urgent hospitalization.

Development of a risk model for adverse drug events in the elderly

The aim of this study was to develop a predictive model for adverse drug events (ADEs) in elderly patients. Socio-demographic and medical data were collected from chart reviews, computerised information and a patient interview, for a population of 929 elderly patients (aged greater than or equal to 65 years) whose admission to the Waveney/B raid Valley Hospital in Northern Ireland was not scheduled. A further 204 patients formed a validation group. An ADE score was assigned to each patient using a modified Naranjo algorithm scoring system. The ADE scores ranged from 0 to 8. For the purposes of developing a risk model, scores of 4 or more were considered to constitute a high risk of an ADE.

Significant decrease in in-hospital mortality and major adverse cardiac events in Swiss STEMI patients between 2000 and December 2007.

To evaluate the in-hospital outcome of STEMI (ST elevation myocardial infarction) patients admitted to Swiss hospitals between 2000 and December 2007, and to identify the predictors of in-hospital mortality and major cardiac events. Data from the Swiss national registry AMIS Plus (Acute Myocardial Infarction and Unstable Angina in Switzerland) were used. All patients admitted between January 2000 and December 2007 with STEMI or a new LBBB (left bundle branch block) were included in the registry. We studied 12 026 STEMI patients admitted to 68 hospitals. The mean age was 64 +/- 13 years and 73% of the patients were male. Incidence of in-hospital death was 7.6% in 2000 and 6% in 2007. Reinfarction fell from 3.7% in 2000 to 0.9% in 2007. Thrombolysis decreased from 40.2% in 2000 to 2% in 2007. Clinical predictors of mortality were: age >65 years, Killips class III or IV, diabetes, Q wave myocardial infarction (at presentation). Patients undergoing percutaneous coronary intervention (PCI) had lower mortality and reinfarction rates (3.9% versus 11.2% and 1.1% versus 3.1% respectively, p <0.001) over time, although their numbers increased from 43% in 2000 to 85% in 2007. Patients admitted to hospitals with PCI facilities had lower mortality than patients hospitalised in hospitals without it, but the demographic characteristics differ widely between the two groups. Both in-hospital mortality and reinfarction decreased significantly over the time, parallel to an increased number of PCI. PCI was also the strongest predictor of survival. In-hospital mortality and reinfarction rate have decreased significantly in Swiss STEMI patients in the last seven years, parallel to a significant increase in the number of percutaneous coronary interventions in addition to medical therapy. Outcome is not related to the site of admission but to PCI access.

A Data Mining Approach for the Identification of Adverse Drug Events (ADE) resulting from Drug-Drug Interactions (DDI) to improve pharmacovigilance

In the current study, epidemiology study is done by means of literature survey in groups identified to be at higher potential for DDIs as well as in other cases to explore patterns of DDIs and the factors affecting them. The structure of the FDA Adverse Event Reporting System (FAERS) database is studied and analyzed in detail to identify issues and challenges in data mining the drug-drug interactions. The necessary pre-processing algorithms are developed based on the analysis and the Apriori algorithm is modified to suit the process. Finally, the modules are integrated into a tool to identify DDIs. The results are compared using standard drug interaction database for validation. 31% of the associations obtained were identified to be new and the match with existing interactions was 69%. This match clearly indicates the validity of the methodology and its applicability to similar databases. Formulation of the results using the generic names expanded the relevance of the results to a global scale. The global applicability helps the health care professionals worldwide to observe caution during various stages of drug administration thus considerably enhancing pharmacovigilance

Student perceptions of adverse health events during ambulance clinical placements

This pilot study intended to augment current literature in the clinical placement field by investigating the frequency and nature of adverse health events experiences by paramedic students undertaking ambulance clinical placements. Supports accessed post event were also reviewed. A purposive sample of fifty-six paramedic students completed the questionnaire. The results indicate that a number of students experience adverse health events while on clinical placement, with fourteen cases of verbal abuse, one case of physical abuse, nine cases of sexualised behavior and seven cases of psychological distress reported. While some case related incidents were flagged by ambulance services and followed up by peer support, students did not initiate any formal support processes themselves. Moreover, no student filed a formal report regarding any of the incidents raised. The results of this pilot study require further investigation. In the interim, the benefits of clinical placements must be weighed against their risks, and processes put in place to minimize the risk to students undertaking clinical placements.

Exploring in-hospital adverse drug events using ICD-10 codes

 Abstract
Objective Adverse drug events (ADEs) during hospital admissions are a widespread problem associated with adverse patient outcomes. The ‘external cause’ codes in the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) provide opportunities for identifying the incidence of ADEs acquired during hospital stays that may assist in targeting interventions to decrease their occurrence. The aim of the present study was to use routine administrative data to identify ADEs acquired during hospital admissions in a suburban healthcare network in Melbourne, Australia.

Methods Thirty-nine secondary diagnosis fields of hospital discharge data for a 1-year period were reviewed for ‘diagnoses not present on admission’ and assigned to the Classification of Hospital Acquired Diagnoses (CHADx) subclasses. Discharges with one or more ADE subclass were extracted for retrospective analysis.

Results From 57 205 hospital discharges, 7891 discharges (13.8%) had at least one CHADx, and 402 discharges (0.7%) had an ADE recorded. The highest proportion of ADEs was due to administration of analgesics (27%) and systemic antibiotics (23%). Other major contributors were anticoagulation (13%), anaesthesia (9%) and medications with cardiovascular side-effects (9%).

Conclusion Hospital data coded in ICD-10 can be used to identify ADEs that occur during hospital stays and also clinical conditions, therapeutic drug classes and treating units where these occur. Using the CHADx algorithm on administrative datasets provides a consistent and economical method for such ADE monitoring.

What is known about the topic? Adverse drug events (ADEs) can result in several different physical consequences, ranging from allergic reactions to death, thereby posing a significant burden on patients and the health system. Numerous studies have compared manual, written incident reporting systems used by hospital staff with computerised automated systems to identify ADEs acquired during hospital admissions. Despite various approaches aimed at improving the detection of ADEs, they remain under-reported, as a result of which interventions to mitigate the effect of ADEs cannot be initiated effectively.

What does this paper add? This research article demonstrates major methodological advances over comparable published studies looking at the effectiveness of using routine administrative data to monitor rates of ADEs that occur during a hospital stay and reviews the type of ADEs and their frequency patterns during patient admission. It also provides an insight into the effect of ADEs that occur within different hospital treating units. The method implemented in this study is unique because it uses a grouping algorithm developed for the Australian Commission on Safety and Quality in Health Care (ACSQHC) to identify ADEs not present on admission from patient data coded in ICD-10. This algorithm links the coded external causes of ADEs with their consequences or manifestations. ADEs identified through the use of programmed code based on this algorithm have not been studied in the past and therefore this paper adds to previous knowledge in this subject area.

What are the implications for health professionals? Although not all ADEs can be prevented with current medical knowledge, this study can assist health professionals in targeting interventions that can efficiently reduce the rate of ADEs that occur during a hospital stay, and improve information available for future medication management decisions.

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%), fatigue (12.3%), and chest pain (9.0%). Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases.

Causes for the underreporting of adverse drug events by health professionals: a systematic review

Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

Impact of educational interventions on adverse drug events reporting

Spontaneous adverse drug events (ADE) reporting is the main source of data for assessing the risk/benefit of drugs available in the pharmaceutical market. However, its major limitation is underreporting, which hinders and delays the signal detection by Pharmacovigilance (PhV). To identify the techniques of educational intervention (EI) for promotion of PhV by health professionals and to assess their impact. A systematic review was performed in the PUBMED, PAHO, LILACS and EMBASE databases, from November/2011 to January/2012, updated in March/2013. The strategy search included the use of health descriptors and a manual search in the references cited by selected papers. 101 articles were identified, of which 16 met the inclusion criteria. Most of these studies (10) were conducted in European hospitals and physicians were the health professionals subjected to most EI (12), these studies lasted from one month to two years. EI with multifaceted techniques raised the absolute number, the rate of reporting related to adverse drug reactions (ADR), technical defects of health technologies, and also promoted an improvement in the quality of reports, since there was increased reporting of ADR classified as serious, unexpected, related to new drugs and with high degree of causality. Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.

Causes for the underreporting of adverse drug events by health professionals: a systematic review

Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.