Management Of Adverse Drug Events Research Articles

Exploring the prevalence and characteristics of adverse drug events among older adults in South Korea using a national health insurance database.

Background: Adverse drug events (ADEs) in the elderly frequently occur because of their multiple chronic diseases and complexity of drug therapy. To better understand adverse drug events, the prevalence and characteristics of adverse drug events in elderly South Korean patients were assessed. Methods: The National Health Insurance databases for 2015 and 2016 were used for the analysis. We included patients aged ≥65years that had at least one claim with the diagnosis codes 'drug-induced,' 'poisoning by drug,' and 'vaccine-associated' each year for the base-case analysis. To minimize the underestimation of adverse drug event prevalence, we also used an extended definition analysis by adding the 'adverse drug event very likely' codes. We estimated the prevalence of adverse drug events by sex, age group, and type of insurance and examined the frequent types of adverse drug events in 2015 and 2016. Results: In the base-case analysis, adverse drug event prevalence in individuals aged 65years and older was 2.75% in 2015 and 2.77% in 2016. With advanced age, the prevalence of adverse drug event tended to increase, peaking in the age group of 75-79years. In addition, the adverse drug event prevalence was higher in females and Medical Aid enrollees. The most frequently occurring adverse drug event was 'allergy, unspecified,' followed by 'other drug-induced secondary parkinsonism,' and 'generalized skin eruption due to drugs and medicaments.' When we examined the extended definition analysis, the prevalence of adverse drug events was 4.47% in 2015 and 4.52% in 2016, which significantly increased from those estimated in the base-case analysis. Conclusion: Among the older adults, the prevalence of adverse drug event was higher in advanced age, females, and Medical Aid enrollees. In particular, allergy and drug-induced secondary parkinsonism frequently occurred. This study provides evidence that health policies addressing the prevention and management of adverse drug events should be a priority for the most vulnerable elderly patients.

Analysis of adverse drug events as a way to improve cancer patient care

PurposeTo define the signals that a new artificial intelligence (AI) system must emit to improve adverse drug events (ADEs) management in oral antineoplastic agents (OAA).MethodsA multidisciplinary group of experts in...

Oral oncolytic treatment for chronic lymphocytic leukemia.

The objective of this article is to review the current supporting literature for the use of oral oncolytics in chronic lymphocytic leukemia, consideration for their use and management of adverse drug events that may limit use. NCCN guidelines were utilized to determine available oral options for treatment of chronic lymphocytic leukemia. A literature review was carried out through PubMed to find relevant clinical trials that evaluated the efficacy and safety of Bruton's tyrosine kinase inhibitors, BCL-2 inhibitors and PI3K-δ inhibitors. Medication package inserts and primary literature regarding toxicity were used to determine appropriate adverse drug event management. A total of 7 clinical trials were found for the evaluation the efficacy and safety of burton tyrosine kinase inhibitor, 1 clinical trial for the BCL-1 inhibitor venetoclax and 4 trials were for PI3K-δ inhibitors. The data from these studies suggest that ibrutinib can be used first line in previously untreated patients and relapsed/refractory patients as well as acalabrutinib. The data also support the use of venetoclax, idelalisib, and duvelisib in relapsed/refractory chronic lymphocytic leukemia patients. The use of oral-only oncolytics could be a viable option for reducing the risk of infection due to limiting exposure to healthcare settings. Current literature suggests oral oncolytics may be an option, but there are several considerations to evaluate including medication adherence, drug-drug interactions, adverse events, and financial toxicity.

Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial

BackgroundAbout 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs.MethodsA cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used.ResultsSixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1–103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2–10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9–10.0], p < 0.001 and aOR = 11.0, CI95 [4.6–26.4], p < 0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management.ConclusionA booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient’s health status.Trial registrationTrial registry identifier NCT01610817 (2012/05/30).

Economic impact of pharmacist interventions in pediatric ambulatory care clinics

ObjectivesAmbulatory care pharmacists have a unique opportunity to identify and prevent adverse drug events (ADEs) throughout a patient’s treatment course. These interventions can reduce unexpected clinic visits or hospitalizations, which may lead to decreased health care costs. However, research on this topic has not been conducted in the pediatric population. This study explored the economic impact of pharmacist interventions related to ADEs in pediatric ambulatory care clinics. The primary objective was to determine the total cost avoidance of pharmacist interventions associated with the prevention or management of ADEs in pediatric ambulatory care clinics. The secondary objectives were to describe and quantify pharmacist interventions related to the prevention and management of ADEs in pediatric ambulatory care clinics. MethodsPharmacist interventions from pediatric ambulatory care clinics were collected from an electronic health record. These interventions were categorized into 1 of 4 categories: Drug interaction, drug not indicated, prevent or manage ADE, or prevent or manage drug allergy. A review panel consisting of ambulatory care pharmacists reviewed the interventions. The expected probability of the event occurring was classified according to the Nesbit method (0-0.6), and the level of care necessary to treat the potential ADE was determined. The levels of care included hospitalization, ambulatory care, and self-care. The cost avoidance associated with each prevented ADE was calculated by multiplying the probability of the ADE occurring by the average charge of the expected level of care. ResultsOf the 8755 interventions documented, 212 were included, leading to a total cost avoidance of $307,210 (range $76,802-$1,071,053). The estimated cost avoidance from each ADE subtype was $128,283 from drug interaction, $20,727 from drug not indicated, $157,993 from prevent or manage ADE, and $207 from prevent or manage drug allergy. ConclusionPediatric ambulatory care pharmacists optimize health care cost savings through the prevention and management of ADEs as integrated members of the health care team.

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

To determine the frequency and the time-course profile of adverse drug events associated with new glucose-lowering drugs in daily practice and to explore factors potentially associated to these events. An inception cohort study was implemented. Adults with type 2 diabetes mellitus initiating a dipeptidyl peptidase-4 inhibitor, a glucagon-like peptide-1 receptor agonist or a sodium-glucose co-transporter-2 inhibitor were eligible for inclusion. Data were collected through baseline and follow-up telephone questionnaires, administered at 2 weeks, 3 months and 6 months. Kaplan-Meier curves and log-rank were computed to compare the time to adverse drug event onset. Cox models were used to explore potential factors associated with adverse drug events. A total of 1328 participants were recruited to the study. In all, 1118 adverse drug events were reported (of which 36% were not listed in the summary of product characteristics) by 41% of participants. The median latency time of adverse drug events reported in ≥1% of participants ranged from 0 to 2 days. Glucagon-like peptide-1 receptor agonist and sodium-glucose co-transporter-2 inhibitor subgroups were associated with an increased likelihood of adverse drug event reporting when compared with the dipeptidyl peptidase-4 inhibitor subgroup. A total of 328 glucose-lowering drugs were withdrawn, more than half as a result of an adverse drug event. More than two-fifths of participants reported an adverse drug event; dipeptidyl peptidase-4 inhibitors led to the highest proportion of unlabelled adverse drug events. Adverse drug event latency time data show that counselling and adverse drug event management should be proactively addressed from treatment initiation. There should be greater focus on prevalent new users of glucose-lowering drugs, who were more complex participants in this study in terms of type 2 diabetes disease, as they were more likely to report an adverse drug event than the incident new users.

Hepatitis C virus infection and the role of a pharmaceutical care program.

The design, implementation, and assessment of a comprehensive pharmaceutical care program (CPCP) for hepatitis C virus (HCV)-infected patients treated with direct-acting antivirals (DAA) are described. The advent of DAA regimens has caused the evolution of the role of hospital pharmacists, leading to the development of more specialized models of pharmaceutical care. Three clinical pharmacists were incorporated into the pharmacy department of a general tertiary teaching hospital in Madrid, Spain, with the aim of developing and implementing a CPCP for HCV-infected patients. Pharmacists were responsible for proposing standards and local guidelines to physicians, monitoring adherence to guidelines, managing drug interactions and adverse drug events (ADEs), providing patient education, and evaluating health outcomes and costs. Implementation steps included (1) estimation of the healthcare demand and pharmacy resources, (2) definition of the workflow of the CPCP, (3) definition of the treatment care plan, for which tools were developed to support pharmaceutical validation, detection, and management of ADEs and drug-drug interactions, and (4) program assessment in terms of safety and cost-effectiveness. The pharmacists' interventions performed, severity of errors intercepted, and patients' satisfaction with the CPCP were also assessed. This CPCP demonstrates that the involvement of the pharmacist throughout the care plan prevents harmful medication errors in this population (0.1 per patient) and prompts significant cost savings (€1.2 million for 1,930 treated patients). The implementation of a CPCP developed by hospital pharmacists for patients treated with DAA for HCV infection is an effective approach for preventing harmful medication errors and improving cost- effectiveness.

1243. Comparative Analysis of Antimicrobial-related Adverse Events in the Outpatient Treatment of Staphylococcal Infections

BackgroundLimited data exist to evaluate safety-related outcomes in Outpatient Parenteral Antimicrobial Therapy (OPAT) patients treated with antimicrobial agents for Gram-positive infections.MethodsThis retrospective, single-center study enrolled Mayo Clinic OPAT patients between 2013 and 2017. The primary objective of the study compared rates of therapy modification due to drug-related toxicity for staphylococcal infections treated with ceftriaxone, cefazolin, nafcillin, oxacillin, vancomycin, daptomycin, ceftaroline, linezolid, or ertapenem. Secondary objectives included determination of the frequency and type of adverse drug events (ADEs) attributed to OPAT and rate of readmission due to ADEs attributed to OPAT.ResultsOne hundred seventy-two patients were identified (cefazolin n = 54, ceftriaxone n = 49, vancomycin n = 30, daptomycin n = 16, nafcillin n = 9, ertapenem n = 6, ceftaroline n = 4, oxacillin n = 3, linezolid n = 1). The overall treatment completion rates were high (153/172, 89.0%). Patients completed an average of 35.3 days (7 to 95) of therapy with their original antibiotic. Fourteen patients required change to a different antibiotic due to antimicrobial toxicity (ceftriaxone=5; vancomycin=2; cefazolin = 2; daptomycin = 2; ceftaroline = 1; nafcillin = 1; oxacillin = 1) and five patients experienced treatment failure required an additional agent (ceftriaxone = 2; nafcillin = 2; linezolid = 1). Adverse drug events (ADEs) were the most common reason for antimicrobial adjustment (14/19, 73.7%). The most common ADEs were hypokalemia (28/172, 16.3%) and diarrhea (25/172, 14.5%). There were only two cases of Clostridium difficile. Thirty-day readmissions due to antimicrobial therapy were low with 11 patients.ConclusionOPAT with Gram-positive agents used for staphylococcal infections is effective, but antimicrobial modifications still occur. Clinicians should be aware of the risk of ADEs and readmissions in OPAT patients. A multidisciplinary approach may enhance management of ADEs and possibly preventing readmissionsDisclosures All authors: No reported disclosures.

Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China.

BackgroundSpontaneous reporting of adverse drug events (ADEs) has long been the cornerstone of pharmacovigilance. Medical institutions in China have been a major source of ADE case reports, but the proportion of reports from tertiary hospitals is low due to the serious underreporting of case reports. The same problem existed in the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU).ObjectiveIn order to increase the number of ADE reports and promote hospital pharmacovigilance, SAHZU’s clinical pharmacists established a pharmacist-led ADE management model. The aim of this paper is to introduce this management model and explore the advantages and disadvantages of the model.MethodsPharmacist-led ADE management model was gradually formed from 2015 to 2017 in the SAHZU. This “pharmacist-led” model is reflected not only in the fact that clinical pharmacists are the main reporters of SAHZU’s ADEs but also in that they are the main groups to analyze and manage ADE and drug errors. The sources of ADEs reported by clinical pharmacists mainly include pharmacy rounds, ADE-related pharmacist consultations, centralized monitoring, ADE warning signal analysis, newly introduced drug evaluations, and drug safety research.ResultsA total of 533 ADEs were reported by SAHZU to China’s spontaneous reporting system (SRS) in 2017, while the data in 2012 was 177, with an increase by 201%. In 2012, the proportion of “new” and “serious” reports was 16.4%. The proportions during the period from 2015 to 2017 were 41.4%, 60.8%, and 52.2%, respectively, which were statistically significant compared with the proportion in 2012. The proportion of ADEs reported by clinical pharmacists during the period from 2014 to 2017 were 51.5%, 57.3%, 68.8%, and 90.8%, respectively, which were statistically significant compared with the proportion in 2013 (P<0.05). There was a correlation between the proportions of severe ADEs and the proportion of ADEs reported by clinical pharmacists (r=0.873, P=0.023). Four hundred eighty four ADE cases reported by clinical pharmacists to China’s SRS in 2017 were mainly found in rounds of clinical pharmacists (74.17% [359/484]).ConclusionThe pharmacist-led pharmacovigilance working model significantly increased the quantity and quality of ADE reporting in SAHZU and promoted pharmacovigilance. This model is worth developing in Chinese tertiary hospitals and the following hospitals, where the physicians working there spend little time and energy on ADE reporting or the cost of physicians is high, while the clinical pharmacist team has strong professional skills.

Effect of different methods for estimating persistence and adherence to new glucose-lowering drugs: results of an observational, inception cohort study in Portugal.

PurposeSeveral methods have been developed for assessing medication-taking behavior; understanding the determinants and variability in estimates obtained is crucial in interpreting results. We estimated persistence and adherence levels to new glucose-lowering drugs (GLDs) in type 2 diabetes mellitus (T2DM) patients using different methods: through the collection of pharmacy records and combining pharmacy records with self-reported data.MethodsWe conducted a prospective observational cohort study of T2DM patients initiating a new GLD. Data were collected at baseline through interviews (demographic and clinical data). Follow-up data included pharmacy records (refill dates and medication possession) and telephone questionnaires (self-declared monitored GLD refill in another pharmacy, reasons for drug withdrawal). The cohort was divided into incident and prevalent new users. Persistence and adherence (proportion of days covered) were estimated for patients using pharmacy records exclusively (Method 1) and ≥1 self-declared statement of being persistent (Method 2). Log-rank tests were used to compare Kaplan–Meier curves of time to nonpersistence.ResultsA total of 1,328 patients were recruited. When considering Method 1, 38.7% (95% confidence interval [95% CI]: 36.0–41.5) of patients were persistent, whereas combining with self-reported information, this estimate increased to 65.6% (95% CI: 62.9–68.2). Using Method 1, the risk of persistence failure was associated with using an oral GLD, living alone and living in a suburban/urban setting. Three hundred and twenty-seven (24.8%) patients stopped to use the inception GLD.ConclusionRegardless of the method used, results indicated low levels of persistence and adherence to a new GLD; however, when combining self-reported information, higher estimates were obtained. Considering pharmacy records exclusively, prevalent new users, who were more complex patients in terms of T2DM disease but more likely to be pharmacy-loyal patients, were significantly more adherent than the incident new users. Barriers and reasons leading to GLD withdrawal, namely adverse drug event management, should be addressed, since they represent half of the reasons for treatment switching or discontinuation.

Efficiency of an interactive program for enhancing patient reporting of adverse drug events in primary care

Introduction Adverse drug events (ADE) are frequents in primary care. They could often be prevented and their complications avoided. One of the main causes is that patients rarely know how to detect ADE. Another cause is inadequate communication between patients and physicians. If patients were effectively trained in identifying and reporting ADE, this should enhance ADE management (and avoid consequences on patient's health). The aim of the InPAct study was to assess an interactive program promoting patients to be active in ADE identification and their reporting to their general practitioners (GP), in order to enhance ADE management in primary care. We focused on patients treated by anti-hypertensive drugs, mainly prescribed in primary care and known to be often responsible for ADE. Methods/design We conducted a cluster randomized controlled stepped wedge trial, with eight clusters of GP. The InPAct program was implemented in the clusters in random order along five successive three-month periods. The program featured: – a patient booklet including information on cardiovascular risks and management of antihypertensive drugs, care plans and patient ADE report forms; – standardized training of physicians in how to present the booklet to the patient. The primary outcome was the active reporting of ADE by patients to their GP within three months of inclusion, after the identification of the ADE by the patients themselves. Total ADE identification (i.e. ADE identified by physician or patient, independently of patient active reporting to their practitioner), knowledge of patient about cardiovascular risks and management of antihypertensive treatments and patient satisfaction about their care management by their general practitioner were evaluated as secondary outcomes. The effect of the intervention was quantified and tested using a mixed logistic model to integrate cluster and time effects. Results We analyzed data for 1095 patients included by 60 different GP belonging to the 8 clusters. Multivariate analyses showed that InPAct program efficiently enhanced active reporting of ADE by patients to their GP (OR = 3.5, 95 CI [1.2–10.1], P = 0.02), but also total ADE identification (OR = 2.6, 95 CI [1.3–5.1], P = 0.01). The anti-hypertensive prescription status (initiation, modification or renewal) was strongly associated with patient active ADE reporting and total ADE identification. Moreover, patient satisfaction about their care management by their GP was higher in the intervention group, as the communication or the given information by the practitioner were concerned. Conclusion The InPAct intervention constituted an original program that was intended to improve ADE management in primary care by enhancing patient involvement in their own care. Finally, the InPAct intervention was efficient not only to enhance patient ADE identification associated with an active reporting, but also total ADE identification and communication between patients and their practitioners. Our study suggests that a better communication between patients and GP could improve patient safety in primary care.

Physician Perceptions of Consultant Pharmacist Services Associated with an Intervention for Adverse Drug Events in the Nursing Facility.

To assess the importance and performance of consultant pharmacist services delivered before and after an intervention to detect and manage adverse drug events among nursing facility residents. Before and after intervention survey of physicians participating in a randomized, controlled trial. Four nonprofit, academically affiliated nursing facilities. Attending physicians providing nursing facility care who were randomized to intervention or control groups. Within the intervention arm, consultant pharmacists provided academic detailing in which trained health care professionals visit practicing physicians in their offices and present the most up-to-date clinical information. Physicians responded to alerts from a medication monitoring system, adjudicated system alerts for adverse drug events (ADEs), and provided structured recommendations about ADE management. We compared physicians' assessments of the importance and performance of consultant pharmacist services before and after the trial intervention in the intervention and control groups. In the intervention group, ratings of importance increased for all 24 survey questions, and 5 of the changes were statistically significant (P < 0.05). In the control group, ratings of importance increased for 16 questions, and none of the changes were statistically significant. In the intervention group, ratings of performance increased for all 24 questions, and 20 of the changes were statistically significant. In the control group, ratings of performance increased for 16 questions, and none of the changes was statistically significant. A multifaceted, consultant pharmacist-led intervention comprising academic detailing, computerized decision support, and structured communication framework can improve physicians' assessment of importance and performance of consultant pharmacist services. ADE = Adverse drug event, M = Statistically significant mean, RCT = Randomized controlled trial, SBAR = Situation, Background, Discussion, Recommendation, SD = Standard deviation.

Adverse Drug Event Nonrecognition in Emergency Departments: An Exploratory Study on Factors Related to Patients and Drugs

BackgroundMany adverse drug events (ADEs) are not identified by emergency physicians. Research has been done to study risk factors for ADEs and help emergency physicians diagnose ADEs. However, no research has specifically examined the causes underlying a lack of attribution of ADEs to medications in emergency department (ED) patients. ObjectiveWe conducted an exploratory study in a medical ED to search for the factors associated with ADE nonrecognition that are related to ED patients and ADEs. MethodsWe conducted an observational study in the medical ED of a French tertiary care hospital between January and December 2009. The study focused on all ADEs, whether or not they were related to the patient's chief complaint. ADEs were identified by an expert physician and pharmacist based on National Electronic Injury Surveillance System criteria. An ADE was considered “attributed” if any evidence of ADE suspicion, ADE diagnosis, or ADE management was documented on ED charts. Factors associated with ADE nonrecognition were identified using multiple logistic regression analysis. ResultsOf the 465 included patients, 90 experienced an ADE at ED visit (19.4%; 95% confidence interval [CI] 15.9%–23.2%). Emergency physicians correctly recognized 36 of these cases (40.0%; 95% CI 29.8%–50.9%). On multivariate analysis, ADE nonrecognition was significantly associated with the following variables: nonrelation between the ADE and the patient's chief complaint; daily prescription of four drugs or more; and hospitalization ADE severity category. ConclusionsOur results emphasize the importance of searching for ADEs in patients with daily polypharmacy or whose chief complaint does not seem to be drug related.

European Respiratory Monograph: Tuberculosis

European Respiratory Monograph is published quarterly by the European Respiratory Society (which also publishes the monthly European Respiratory Journal), with each issue devoted to “a specific clinical area of respiratory health.” These monographs—free for all members of the Society—can also be purchased individually, and fall into a category between journal supplement and textbook. The recent issue devoted to tuberculosis is more the former than the latter, although the text is longer than a typical supplement and the volume itself is closer in physical size to a tall paperback book (17 × 25 cm). With 18 chapters by 55 authors—each 4000 to 8000 words in length—the book reads more like an anthology of related articles rather than an integrated and unified whole. Each chapter has a brief abstract, and redundancy occurs between some chapters. This is not necessarily a bad thing, as not every reader will want to read the book in its entirety. Tuberculosis also falls in the middle ground between being an elementary text for beginners and an update for experts. Several chapters review basic concepts familiar to most tuberculosis specialists, whereas others describe cutting-edge research and provide advanced management guidelines for extensively drug-resistant tuberculosis. The first chapter, “Microbiology of M. tuberculosis and a new diagnostic test for TB” provides an excellent, concise, and current review of tuberculosis pathogenesis and a brief overview of diagnostics. Chapter 10, devoted entirely to diagnostics, covers the topic in detail. Chapter 4, titled “Human genetic variability and susceptibility to pulmonary TB,” effectively describes laboratory techniques and scientific rationale. However, a detailed listing of negative or inconclusive studies, organized by each receptor or cytokine, will be slow going for all but the most dedicated geneticist or immunologist. Additional chapters cover “Epidemiology of TB” (including mechanisms of transmission), “TB in children” (largely understudied to date), “TB as an occupational disease” (particularly health care and mining), and “TB in the immunocompromised host” (including patients with solid organ transplants and hematologic malignancies). There are paired chapters on prevention of tuberculosis and drug resistance in both high- and low-incidence countries. The chapter on drug resistance in high-incidence countries includes a brief but clear-eyed examination of the ethical dilemmas raised by patients who fail treatment for drug-resistant tuberculosis and are deemed “incurable,” but who remain a threat to society. The chapter on tuberculosis vaccine development is inspiring and should generate optimism in those who wonder why there has not been a new tuberculosis vaccine in nearly a century. Chapters on “Treatment of TB” and “Management of adverse drug events in TB therapy” are well-written for the nontuberculosis specialist. They provide guiding principles of tuberculosis therapy and specific examples of regimens. The chapter on tuberculosis in migrants highlights an important issue, as such patients are responsible for much of the tuberculosis incidence in the developed world. As expected in a multiauthored anthology format, writing styles and quality vary from chapter to chapter. Some authors hew closely to published evidence. whereas others either openly offer recommendations that contradict existing guidelines or provide opinion where existing guidelines are silent. Admittedly, the evidence base for much of tuberculosis management—especially drug-resistant tuberculosis—is weak, but I would like to have seen these authors acknowledge that they were making an anecdotal recommendation rather than presenting their advice with the same vigor as that for which the evidence is strong. Not surprisingly, the book focuses heavily on Europe, although 2 chapters devoted to high- incidence countries are written by non-European authors and deal primarily with South Africa. Only passing mention is given to India and China, which together account for a third of all tuberculosis cases and half of drug-resistant tuberculosis cases worldwide. The chapter on nontuberculous mycobacteria addresses the most prevalent and clinically significant species in Europe (which differ from other areas of the world). Tuberculosis provides virtually no history of the disease, nor much description of molecular epidemiologic techniques. This is not a text for someone starting from scratch, and trainees as well as general internists seeking a core text would find more suitable alternatives. Still, the editors and authors have done a commendable job identifying and describing major recent advances in the field and providing the context into which these advances fit. In addition, each chapter provides a robust set of current references that will be useful to those seeking more information on a given topic. Tuberculosis will likely appeal most to pulmonary and infectious diseases specialists with some clinical or research experience in tuberculosis who are looking for an update on this broad and rapidly expanding field. To that end, the middle ground between textbook and supplement may be a useful niche of its own.

Cost analysis of HIV treatment and drug-related adverse events when fixed-dose combinations of antiretrovirals (FDCAs) were stopped, versus continuation with FDCAs

BackgroundThe launch of a generic form of lamivudine (g3TC), included in several fixed-dose combinations of antiretrovirals (FDCAs), led to considering switching stable patients from lamivudine and emtricitabine-containing FDCAs to separate...

Self-reported adverse drug events and the role of illness perception and medication beliefs in ambulatory heart failure patients: A cross-sectional survey

Background Identifying patients with heart failure (HF) who are at risk of experiencing symptomatic adverse drug events (ADEs) is important for improving patient care and quality of life. Several demographic and clinical variables have been identified as potential risk factors for ADEs but limited knowledge is available on the impact of HF patients’ beliefs and perceptions on their experience of ADEs. Objective The purpose of the study was to identify the relationship between HF patients’ illness perception and medication beliefs and self-reported ADEs. Design A cross-sectional survey was performed between November 2008 and March 2009. Settings One university medical centre, two regional hospitals and 20 general practitioners in the Netherlands participated in the study. Participants 495 patients with HF were included. Methods Patients completed the validated Revised Illness Perception Questionnaire (IPQ-R) and the Beliefs about Medication Questionnaire (BMQ) which collected data on their illness perception and medication beliefs. In addition, data on ADEs as experienced in the previous four weeks were collected through an open-ended question and a symptom checklist. Multivariate logistic regression was performed to identify factors associated with these ADEs. Results In total, 332 (67%) patients had experienced ADEs in the previous four weeks, of whom 28% reported dry mouth, 27% dizziness and 19% itchiness as the most prevalent. In the adjusted multivariate analysis, disease-related symptoms (illness identity) (OR for 1–5 symptoms 3.57; 95% CI 2.22–5.75, OR for >5 symptoms 7.37; 95% CI 3.44–15.8), and general beliefs about medication overuse (OR 1.07; 95% CI 1.01–1.13) were independently associated with experiencing ADEs, whereas none of the demographic or clinical factors were significant. Conclusions HF patients who perceive a high number of disease symptoms and have negative medication beliefs are at higher risk of experiencing self-reported ADEs. We suggest that future studies and interventions to improve ADE management should focus on negative medication beliefs and assisting patients in differentiating disease symptoms from ADEs.

Perceived Adverse Drug Events in Heart Failure

Patients with heart failure (HF) often perceive adverse drug events (ADEs), affecting quality of life. For weighing the benefits and burden of medication in HF care, knowledge on patients' perception of ADEs is needed. Our aim was to assess these ADE perceptions and to identify factors related to these perceptions. A cross-sectional study was performed including HF patients recruited from primary care and outpatient clinics. Patients were included in the analysis if they perceived an ADE in the past 4 weeks. This information was collected using an open-ended question and a symptom checklist. Data on ADE perception were obtained using a modified version of the Revised Illness Perception Questionnaire. Demographic, clinical, and ADE characteristics were collected by self-administered questionnaire and chart review. The relations between these factors and ADE perceptions were analyzed using regression analyses. In total, 261 HF patients perceived an ADE and completed the questionnaire. Patients reported 814 ADEs, of which 26% of the patients reported dizziness and 24% reported dry mouth as being the most prevalent. Almost half of the patients (46%) perceived their ADE as something serious, with major consequences for their daily life (40%) and reported to be worried (36%) about the ADE. Patients perceived the ADE as a chronic problem (91%), and the majority believed more in the ability of the health care provider to control the ADE (61%) than in their own ability (46%). Demographic and clinical variables had a limited contribution to the explained variance of ADE perceptions after adjusting for ADE characteristics, such as perceived severity. Patients with HF perceive particular negative consequences and emotional distress of symptomatic ADE. Open communication between patients and providers with attention for patients ADE perceptions would be valuable during the decision process of ADE management and may result in a regimen aligned with patients' preferences and needs.

Unintentional Therapeutic Errors Involving Insulin in the Ambulatory Setting Reported to Poison Centers

Adverse drug events in the ambulatory care setting are not uncommon and can cause significant morbidity. Little research has been published on the management of adverse drug events involving insulin in the outpatient setting. To analyze data on patients with unintentional therapeutic errors involving insulin managed by 9 regional poison control centers. A retrospective search was performed for all records involving insulin at 9 poison centers, covering the population of 4 states for the years 2000-2009. A subgroup of the study population was selected with a reason for exposure of "unintentional-therapeutic error." There were 3819 insulin exposures reported, with an increase in the annual incidence of insulin exposures of 279% (from 170 to 645 patients/year) and a mean annual increase of 18%. Of the insulin exposures, 2584 were unintentional therapeutic errors (68%). The percentage of all insulin exposures that were unintentional therapeutic errors increased progressively, from 41% to 78%. There was a 495% increase in annual incidence of unintentional therapeutic errors involving insulin, with a mean annual increase of 28%. Unintentional therapeutic errors involving insulin occurred primarily in adults >40 years (73%), with 63% occurring in women. There was a pronounced increase in unintentional therapeutic errors involving insulin in the later evening hours, with 71% occurring between 1800 and 2400 and reaching a peak at 2200. The majority (n = 1803; 70%) of patients were managed in a non-health-care facility location, primarily their own residence. This is the first report of an increasing trend of insulin-related unintentional therapeutic errors in the ambulatory setting. Our study highlights a number of striking features, including: (1) a consistent and dramatic increase of unintentional therapeutic errors involving insulin over the 10-year period, (2) a high incidence of unintentional therapeutic errors involving insulin in the late evening hours, and (3) a high incidence of unintentional therapeutic errors involving insulin involving adults >40 years and females. With their 24/7 availability, poison centers appear to be an increasingly important resource for patients experiencing unintentional therapeutic errors involving insulin.

Evaluation of the Electronic Adverse Drug Event Management System

An electronic reporting system is indispensable in facilitating adverse drug event (ADE) management. Much of the literature has shown that not only the ADE report rate can be increased significantly by a well-designed electronic system but also the communication between health care professionals can be improved. Moreover, developing an electronic reporting system is essential for preventing ADEs in a cost-effective manner. The purpose of this study was to compare the efficiency and influence of an electronic ADE management system with a traditional working model at a medical center. An electronic ADE management system was integrated with the four intranet systems in the hospital and made available at every computer terminal. An ADE committee met once every 4 weeks to discuss the strategies to promote the rational use of drugs, such as introducing an automated computer warning system based on sentinel cases. Details of ADEs were collected for 39 months before and after the new system was introduced. Characteristics of ADEs before and after implementation of the new system were analyzed using the χ2 test. The number of ADE reports increased 3.6-fold after the electronic system (394 cases in contrast to 108 cases, p < 0.001) was established. ADEs reported by physicians increased from 36 (33%) to 222 (56%), and those reported by nurses increased from 0 (0%) to 72 (18%). Additionally, the percentage of preventable ADEs decreased significantly from 53% to 21% (p < 0.001). The distribution of ADE severity patterns and varieties of medication involved were also significantly affected by the system (p < 0.001). The electronic ADE management system evidently increased interdisciplinary involvement that led to enhanced medication safety. Moreover, continuous operation and improvement of the management system by incorporating technologies to fit future demands of ADE management is essential for improving patient safety.

310 Management of adverse drug events

310 Management of adverse drug events