DETECTING ADVERSE DRUG REACTIONS IN THE NURSING HOME SETTING USING A CLINICAL EVENT MONITOR

Adverse drug reactions (ADRs) are the most clinically significant and costly medication-related problems in nursing homes (NH), and are associated with an estimated 93,000 deaths a year and as much as $4 billion of excess healthcare expenditures. Current ADR detection and management strategies that rely on pharmacist retrospective chart reviews (i.e., usual care) are inadequate. Active medication monitoring systems, such as clinical event monitors, are recommended by many safety organizations as an alternative to detect and manage ADRs. These systems have been shown to be less expensive, faster, and identify ADRs not normally detected by clinicians in the hospital setting. The main research goal of this dissertation is to review the rationale for the development and subsequent evaluation of an active medication monitoring system to automate the detection of ADRs in the NH setting. This dissertation includes three parts and each part has its own emphasis and methodology centered on the main topic of better understanding of how to detect ADRs in the NH setting.The first paper describes a systematic review of pharmacy and laboratory signals used by clinical event monitors to detect ADRs in hospitalized adult patients. The second paper describes the development of a consensus list of agreed upon laboratory, pharmacy, and Minimum Data Set signals that can be used by a clinical event monitor to detect potential ADRs. The third paper describes the implementation and pharmacist evaluation of a clinical event monitor using the signals developed by consensus.The findings in the papers described will help us to better understand, design, and evaluate active medication monitoring systems to automate the detection of ADRs in the NH setting. Future research is needed to determine if NH patients managed by physicians who receive active medication monitoring alerts have more ADRs detected, have a faster ADR management response time, and result in more cost-savings from a societal perspective, compared to usual care

Adverse Drug Reactions, Nursing and Policy: A Narrative Review

Medicines' management is a priority in healthcare delivery, but weaknesses in the monitoring and management of Adverse Drug Reactions (ADRs) cause unplanned hospital admissions, financial burdens on healthcare systems, patient discomfort, morbidity, and mortality. This paper suggests policies and strategies that would help nurses minimise and manage ADRs to prescription medicines. The literature was searched for strategies to promote nurses' engagement with monitoring patients for potential ADRs. This narrative review opens the discussion by exploring the potential for nurse policy makers to address this hiatus in care. Recognition, amelioration and reporting of ADRs are important components of safe care, areas where nurses could make important contributions through collaboration in policy development, healthcare reform and enhanced nursing practice. Minimising ADRs necessitates paying sufficient attention to their recognition and prevention. Healthcare providers, particularly nurse leaders, need to commit to strategies to identify and address any adverse consequences of treatments, including ADRs: the axiom primum non nocere (first, do no harm) should be applied to all healthcare delivery. The application of structured nurse-led medicines' monitoring in practice depends on the collaboration of all healthcare professionals, co-ordinated by nurses. Incorporation of strategies to identify and ameliorate preventable ADRs into routine work will require the support of policy makers

Automatic Detection of Adverse Drug Events in Geriatric Care: Study Proposal

BACKGROUND One-third of older inpatients experience adverse drug events (ADEs), which increase their mortality, morbidity, and health care use and costs. In particular, antithrombotic drugs are among the most at-risk medications for this population. Reporting systems have been implemented at the national, regional, and provider levels to monitor ADEs and design prevention strategies. Owing to their well-known limitations, automated detection technologies based on electronic medical records (EMRs) are being developed to routinely detect or predict ADEs. OBJECTIVE This study aims to develop and validate an automated detection tool for monitoring antithrombotic-related ADEs using EMRs from 4 large Swiss hospitals. We aim to assess cumulative incidences of hemorrhages and thromboses in older inpatients associated with the prescription of antithrombotic drugs, identify triggering factors, and propose improvements for clinical practice. METHODS This project is a multicenter, cross-sectional study based on 2015 to 2016 EMR data from 4 large hospitals in Switzerland: Lausanne, Geneva, and Zürich university hospitals, and Baden Cantonal Hospital. We have included inpatients aged ≥65 years who stayed at 1 of the 4 hospitals during 2015 or 2016, received at least one antithrombotic drug during their stay, and signed or were not opposed to a general consent for participation in research. First, clinical experts selected a list of relevant antithrombotic drugs along with their side effects, risks, and confounding factors. Second, administrative, clinical, prescription, and laboratory data available in the form of free text and structured data were extracted from study participants' EMRs. Third, several automated rule-based and machine learning-based algorithms are being developed, allowing for the identification of hemorrhage and thromboembolic events and their triggering factors from the extracted information. Finally, we plan to validate the developed detection tools (one per ADE type) through manual medical record review. Performance metrics for assessing internal validity will comprise the area under the receiver operating characteristic curve, F$_{1}$-score, sensitivity, specificity, and positive and negative predictive values. RESULTS After accounting for the inclusion and exclusion criteria, we will include 34,522 residents aged ≥65 years. The data will be analyzed in 2022, and the research project will run until the end of 2022 to mid-2023. CONCLUSIONS This project will allow for the introduction of measures to improve safety in prescribing antithrombotic drugs, which today remain among the drugs most involved in ADEs. The findings will be implemented in clinical practice using indicators of adverse events for risk management and training for health care professionals; the tools and methodologies developed will be disseminated for new research in this field. The increased performance of natural language processing as an important complement to structured data will bring existing tools to another level of efficiency in the detection of ADEs. Currently, such systems are unavailable in Switzerland. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/40456

Characterising the types of paediatric adverse events detected by the global trigger tool - CareTrack Kids

Introduction A common method of learning about adverse events (AEs) is by reviewing medical records using the global trigger tool (GTT). However, these studies generally report rates of harm. The aim of this study is to characterise paediatric AEs detected by the GTT using descriptive and qualitative approaches. Methods Medical records of children aged 0–15 were reviewed for presence of harm using the GTT. Records from 2012–2013 were sampled from hospital inpatients, emergency departments, general practice and specialist paediatric practices in three Australian states. Nurses undertook a review of each record and if an AE was suspected a doctor performed a verification review of a summary created by the nurse. A qualitative content analysis was undertaken on the summary of verified AEs. Results A total of 232 AEs were detected from 6,689 records reviewed. Over four-fifths of the AEs (193/232, 83%) resulted in minor harm to the patient. Nearly half (112/232, 48%) related to medication/intravenous (IV) fluids. Of these, 83% (93/112) were adverse drug reactions. Problems with medical devices/equipment were the next most frequent with nearly two-thirds (32/51, 63%) of these related to intravenous devices. Problems associated with clinical processes/procedures comprise one in six AEs (38/232, 16%), of which diagnostic problems (12/38, 32%) and procedural complications (11/38, 29%) were the most frequent. Conclusion Adverse drug reactions and issues with IVs are frequently identified AEs reflecting their common use in paediatrics. The qualitative approach taken in this study allowed AE types to be characterised, which is a prerequisite for developing and prioritising improvements in practice

Medication Safety in Municipal Health and Care Services

Medicines constitute an essential part of healthcare delivery and help to prevent or treat illness, influence quality of life, and generally increase life expectancy. However, medications can also cause harm if prescribed irrationally, dispensed or used incorrectly, and monitored or followed up insufficiently. In this anthology, we showcase the challenges of medication management and the rational use of medicines in municipal health and care services, and present various strategies and measures related to medication safety. The contributors are researchers representing a wide range of disciplines, with experience from different levels of healthcare services and different areas within the research and education sectors. We hope to raise awareness, engage and enable discussion of initiatives and strategies to improve patient safety related to medications in municipal health and care services, and create a basis for further research to promote safe medication management and rational use of medicines. This anthology will be of interest to anyone involved in or concerned with medication safety, primarily healthcare professionals, academic staff, researchers, policymakers, and managers in healthcare services

Assessing the Sensitivity of the Canadian Adverse Event Following Immunization Surveillance System ( CAEFISS)

Background: Vaccines are important to public health, but because of the way they are manufactured, their mechanism of action, and their indicated population, careful monitoring of their adverse events is necessary. Canada has a national surveillance system that collects reports on adverse events that may be associated with vaccine administration. Sensitivity is one of the tools used with surveillance systems to study the extent and characteristics of reporting of a surveillance system. To date, the sensitivity of the Canadian system has not been assessed. Purpose: To assess the sensitivity of the Canadian Adverse Event Following Immunization Surveillance System (CAEFISS). Methods: Based on specific adverse events following immunization (AEFI) and vaccines chosen for the study, a thorough literature search was completed to find the best source which identifies expected rates of AEFI. Studies used were assessed based on quality and sample size. The expected rates of AEFI, in combination with public health estimates of vaccine coverage rates, were used to estimate the expected number of reports. The reports provided the actual number of events used to calculate the sensitivity. Sensitivity was compared based on year of administration, age group, and type of AEFI. Results: The overall sensitivity of the CAEFISS varied from 1.0% to 136.6% for various AEFI for the years 1997 to 2008. For influenza the sensitivity was found to be 93.6% and 136.3% for GBS and anaphylaxis respectively. For DTaP, the rates were found to be 15.0%, 1.0%, and 21.2% for anaphylaxis, HHE, and seizures respectively, and for MMR the rates were 16.5%, 52.7%, and 12.7% in relation to anaphylaxis, thrombocytopenia, and seizures respectively. Conclusions: This is the first assessment of the sensitivity of the CAEFISS, and this study found that the system has reasonable ability to detect AEFI on a national level. CAEFISS had comparable senstivity to other vaccine reporting systems. Many of the AEFI had sensitivity values higher than the 5%-10% range traditionally seen in other passive surveillance systems related to adverse events. The greatest variation of sensitivity was seen between vaccines. Rarity and timing of the AEFI may also impact the sensitivity. Variation of sensitivity and the variation found in the sensitivity analysis lend to the further development and implementations of case definitions for rarer adverse events, especially anaphylaxis. Further research of other factors that impact reporting is necessary

Assessment of neuroleptic-induced movement disorders in a naturalistic schizophrenia population

The prevalence and assessment of neuroleptic-induced movement disorders (NIMDs) in a naturalistic schizophrenia population that uses conventional neuroleptics were studied. We recruited 99 chronic schizophrenic institutionalized adult patients from a state nursing home in central Estonia. The total prevalence of NIMDs according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) was 61.6%, and 22.2% had more than one NIMD. We explored the reliability and validity of different instruments for measuring these disorders. First, we compared DSM-IV with the established observer rating scales of Barnes Akathisia Rating Scale (BARS), Simpson-Angus Scale (SAS) (for neuroleptic-induced parkinsonism, NIP) and Abnormal Involuntary Movement Scale (AIMS) (for tardive dyskinesia), all three of which have been used for diagnosing NIMD. We found a good overlap of cases for neuroleptic-induced akathisia (NIA) and tardive dyskinesia (TD) but somewhat poorer overlap for NIP, for which we suggest raising the commonly used threshold value of 0.3 to 0.65. Second, we compared the established observer rating scales with an objective motor measurement, namely controlled rest lower limb activity measured by actometry. Actometry supported the validity of BARS and SAS, but it could not be used alone in this naturalistic population with several co-existing NIMDs. It could not differentiate the disorders from each other. Quantitative actometry may be useful in measuring changes in NIA and NIP severity, in situations where the diagnosis has been made using another method. Third, after the relative failure of quantitative actometry to show diagnostic power in a naturalistic population, we explored descriptive ways of analysing actometric data, and demonstrated diagnostic power pooled NIA and pseudoakathisia (PsA) in our population. A subjective question concerning movement problems was able to discriminate NIA patients from all other subjects. Answers to this question were not selective for other NIMDs. Chronic schizophrenia populations are common worldwide, NIMD affected two-thirds of our study population. Prevention, diagnosis and treatment of NIMDs warrant more attention, especially in countries where typical antipsychotics are frequently used. Our study supported the validity and reliability of DSM-IV diagnostic criteria for NIMD in comparison with established rating scales and actometry. SAS can be used with minor modifications for screening purposes. Controlled rest lower limb actometry was not diagnostically specific in our naturalistic population with several co-morbid NIMDs, but it may be sensitive in measuring changes in NIMDs.Väitoskirjatyö "Assessment of neuroleptic-induced movement disorders in a naturalistic schizophrenia population" osoittaa, että kroonista skitsofreniaa sairastavilla, vanhoja psykoosilääkkeitä saavilla potilailla on runsaasti liikehäirioitä ja usein useampi liikehäiriö samanaikasesti. Tutkimus vertaili ja arvioi eri mittauskeinojen käyttökelpoisuutta vanhojen psykoosilääkkeiden aiheuttamien neurologisten haittavaikutusten arvioinnissa. Psykoosien lääkehoidon ensimmäistä kehitysvaihetta edustavat, 1950-luvulla käyttöön tulleet tavanomaiset psykoosilääkkeet ovat tehokkaita psykoosin ns. positiivisen oireisiin, mutta niiden käyttöä ovat rajoittaneet erilaiset haittavaikutukset. Keskeisimpiä näistä ovat mm. pakkoliikkeinä, vapinana ja jäykkyytenä ilmenevät neurologiset oireet, jotka esiintyessään heikentävät potilaan hoitomyöntyvyyttä, mikä vaarantaa pitkällä aikavälillä hoidon toteutumisen. Tästä johtuen kahden viimeisen vuosikymmenen aikana on pyritty kehittämään tehokkaampia ja paremmin siedettyjä psykoosilääkkeitä, joiden käyttömahdollisuudet kuitenkin vaihtelevat maasta toisen niiden korkeasta hinnasta johtuen. Tutkimus toteutettiin poikkileikkaustutkimuksena Viron suurimmassa psykiatrisessa hoitokodissa. Tutkimuksen osallistuneet 99 potilasta olivat keski-ikäisiä, pitkään skitsofrenian takia hoidettavina olleita potilaita, joista noin 80 prosenttia käytti vanhoja/ tavanomaisia psykoosilääkkeitä. Heistä noin 60 prosentilla oli todettavissa jokin neurologinen haittaoire, jonka esiintyvyyttä ja haittaavuutta arviointiin eri arviointimenetelmin sekä uutta tekniikkaa edustavalla aktometrialla. Tutkimuksessa käytettiin haastatteluun ja havainnointiin perustuvina mittausmenetelminä nykyiseen diagnostiseen järjestelmään perustuvaa liikehäiriöiden arvioitia, Barnesin akatisia-astekkoa (BARS), Simpson-Angusin parkinsonismiastekkoa (SAS) ja tardiivin dyskinesian arvioimiseksi epänormaalien tahattomien liikkeiden asteikkoa (AIMS). Aktometria osoittautui arviointiastekkojen rinnalla hyödylliseksi lisäarviointimenetelmäksi, joka ei kuitenkaan yksinään osoittautunut riittäväksi em. liikehäiriöiden alamuotojen erotusdiagnostiikassa

Medication Safety in Municipal Health and Care Services

Medicines constitute an essential part of healthcare delivery and help to prevent or treat illness, influence quality of life, and generally increase life expectancy. However, medications can also cause harm if prescribed irrationally, dispensed or used incorrectly, and monitored or followed up insufficiently. In this anthology, we showcase the challenges of medication management and the rational use of medicines in municipal health and care services, and present various strategies and measures related to medication safety. The contributors are researchers representing a wide range of disciplines, with experience from different levels of healthcare services and different areas within the research and education sectors. We hope to raise awareness, engage and enable discussion of initiatives and strategies to improve patient safety related to medications in municipal health and care services, and create a basis for further research to promote safe medication management and rational use of medicines. This anthology will be of interest to anyone involved in or concerned with medication safety, primarily healthcare professionals, academic staff, researchers, policymakers, and managers in healthcare services

Using the theory of planned behavior to predict Texas pharmacists' intention to report serious adverse drug events

textThe purpose of this dissertation was to use the theory of planned behavior (TPB) to predict Texas pharmacists’ intention to report serious adverse drug effects (ADEs) to the Food and Drug Administration (FDA). The study explored the utility of the TPB model constructs (attitude [A], subjective norm [SN], perceived behavioral control [PBC]), as well as past reporting behavior (PRB), and perceived moral obligation (PMO) to predict pharmacists’ intention to report serious ADEs to the FDA. The study also determined if the pharmacists’ A, SN and PBC were related to practice characteristics and demographic factors. A survey was developed based on two focus group interviews, pretested and mailed to 1,500 Texas practicing pharmacists. An overall response rate of 26.4 percent was obtained (n = 377 pharmacists). Overall, pharmacists intended to report serious ADEs, had a favorable attitude towards reporting, were somewhat influenced by social norms regarding reporting and perceived themselves to have some control over reporting serious ADEs to the FDA. For direct measures, A and SN were significant predictors of intention to report serious ADEs, but PBC was not. The TPB constructs together accounted for 34.0 percent of the variance in intention to report serious ADEs to the FDA. Using indirect measures, A, SN and PBC were significant predictors of intention and together accounted for 28.8 percent of the variance in intention to report serious ADEs. PRB and PMO improved the explanatory power of the regression models (direct and indirect measures) over and above the TPB constructs. Unlike most other practice characteristics and demographic factors examined, knowledge was significantly related with the TPB constructs. In summary, A, SN, PBC (indirect measures), PRB, and PMO influence the formation of pharmacists’ intention to report serious ADEs. The TPB has utility in predicting ADE reporting behavior. Pharmacy educators should explore pharmacists’ attitudes, beliefs, and expectations of important others in designing educational programs. Strategies to help pharmacists report more serious ADEs should focus on altering their perception of social pressure towards reporting and addressing the barriers towards ADE reporting (e.g., lack of knowledge).Pharmac

Vigilance of Certified Registered Nurse Anesthetists

Vigilance of certified registered nurse anesthetists (CRNAs) is an integral component of the care they provide patients under general anesthetic. the practice of CRNas is important as the official seal of the American Association of Nurse Anesthetists (AANA). on the seal, Morpheus, the god of dreams, is shown holding the Lamp of Learning, by the light of which he keeps vigil (Hirter & Van Nest, 1995). as the patients remain unconscious under general anesthesia, CRNas remain the patients\u27 eyes and ears remains responsive to their needs. the CRNa must remain attentive to the patient\u27s needs by continuously monitoring the patient in the operating room and constantly communicating with the operating room staff. Complete focus must be maintained to avoid any mishaps or adverse events. in essence, CRNas must remain focused and vigilant when caring for their patients. the importance of vigilance is essential and undeniable for optimal patient outcomes, but the process has yet to be defined and understood. Fourteen CRNas participated in phone interviews in this study. CRNas practicing in both hospital and ambulatory settings were included. Through data analysis, using constant comparison, a model emerged that explained vigilance in the CRNa process. the core category was Using Senses, and the model had seven subcategories. the categories below reflected stages in the process model. the process begins with the CRNA\u27s care of the patient (Being Alert). This is when the CRNa assumes care of the patient, maintains a high level of alertness, and does not get mentally fatigued. Being alert allows the CRNa to be ready to care for their patients. When CRNas are alert, they are attentive and engaged (Being Attentive and Engaged) in watching over their patients. This allows the CRNa to be constantly aware and pay attention to their patients. Being attentive and engaged allows the CRNa to be focused (Focusing) on every aspect of patient care. Unfortunately, the operating room is a dynamic environment, where distractions, such as music, conversation, and technology can distract clinicians from being engaged in the care of their patients. These distractions can, but do not always, occur. When they do occur, the CRNa redirects their attention and begins to focus, which allows CRNas to use their senses to look, listen, and feel (Looking, Listening, and Touching). Using the senses of looking, listening, and feeling, the CRNa can pick up on events or look for cues that can help continue or improve care by anticipating changes at random intervals during the case. by using their senses and picking up on cues, the CRNa knows what is going on with the patient (Know What Is Happening). the findings of this study have implications for nurse administrators. This theory will be informative and helpful for hospital administrators, as they may want to implement a policy similar to that which the aviation industry developed for pilots reporting for duty. in regards to nursing research, the Institute of Medicine ([IOM], 2003) has used the phenomena of vigilance and surveillance interchangeably, but the processes are not interchangeable. There is a distinction between these two concepts. This study provides a link between the two phenomena. Vigilance is a link to the process of surveillance and studying it will help the researcher expound upon the previous surveillance research in nursing