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Drug Events (drug + event)
Kinds of Drug Events Selected AbstractsHaematological malignancies developing in previously healthy individuals who received haematopoietic growth factors: report from the Research on Adverse Drug Events and Reports (RADAR) projectBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2006Charles L. Bennett Summary Pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) and granulocyte colony-stimulating factor (G-CSF) promote haematopoietic progenitor cell maturation. We reviewed the findings for healthy volunteers/donors who developed haematological malignancies following PEG-rHuMGDF or G-CSF administration. Information was reviewed for three of 538 volunteers who received PEG-rHuMGDF in clinical trials and two of 200 donors who underwent G-CSF mobilised stem cell harvesting procedures for sibling stem cell transplants. Mantle cell, diffuse large B-cell lymphoma and chronic lymphocytic leukaemia were diagnosed 1,5 years after PEG-rHuMGDF exposure among three volunteers. For one patient, thrombocytopenia due to autoantibodies to PEG-rHuMGDF developed shortly after PEG-rHuMGDF administration and persisted until chemotherapy was administered. All three achieved complete remission, although one patient relapsed. Acute myeloid leukaemia was diagnosed 4 and 5 years after G-CSF mobilisation in two donors who underwent peripheral blood stem cell donation for sibling allogeneic haematopoietic stem cell transplantation. Following intensive chemotherapy, one died from acute leukaemia and the second is in complete remission. Controversy exists over the appropriateness of administering haematopoietic growth factors to healthy individuals. While a causal relationship with haematological malignancies cannot be demonstrated, long-term follow-up among healthy individuals who receive haematopoietic growth factors is needed. [source] The relationship between computerized physician order entry and pediatric adverse drug events: a nested matched case-control study,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2009Feliciano Yu MD, MSPH Abstract This study assesses the impact of computerized physician order entry (CPOE) implementation in pediatric hospitals on reported adverse drug events. Using a nested matched case-control design; we linked CPOE implementation information from the health information management systems society analytics database with reported adverse drug event (ADE) from the national association of children's hospitals and related institutions case mix comparative data program. Differences were examined using univariate and multivariate conditional logistic regression analyses. Patients from CPOE hospitals were more frequently seen in larger hospitals have more co-morbidities than those from non-CPOE hospitals. When matched by admitting diagnosis, age, gender and race, ADE cases were associated with more reported co-morbidities, and were reported less frequently in hospitals with CPOE. Patients from hospitals without CPOE were 42% more likely to experience reportable ADE after adjusting for the presence of co-morbidities. In conclusion, we found significant beneficial associations between reportable ADE and CPOE adoption in a representative sample of pediatric hospitals. Copyright © 2009 John Wiley & Sons, Ltd. [source] Acute Hepatitis Associated with Treatment of Peyronie's Disease with Potassium Para-Aminobenzoate (Potaba)THE JOURNAL OF SEXUAL MEDICINE, Issue 12 2008Joey Roy ABSTRACT Introduction., Potassium para-aminobenzoate is an agent used in the treatment of sclerotic diseases including Peyronie's disease of the penis. It has been reported that this medication may have been responsible for cases of acute liver injury. Aim., To inform clinicians of the possibility of an adverse drug event associated with the oral intake of potassium para-aminobenzoate by reporting an additional case and compiling information from previous reports. Methods., The affected patient's medical records were diligently reviewed; all available and relevant information pertaining to this adverse event is reported. Similar case reports were analyzed and compared, and relevant information was compiled in this report. Results., The patient enjoyed a full biochemical recovery from his hepatitis 4 months after discontinuation of potassium para-aminobenzoate. Conclusion., To date, the oral use of potassium para-aminobenzoate has been reported to be linked to acute liver injury in six individuals. Appropriate management of this adverse drug event is the immediate discontinuation of the offending drug and general patient support measures. Roy J, and Carrier S. Acute hepatitis associated with treatment of Peyronie's disease with potassium para-aminobenzoate (Potaba). J Sex Med **;**:**,**. [source] A retrospective analysis of VIOXX in Australia: using clinical trial data and linked administrative health data to predict patient groups at risk of an adverse drug eventAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 4 2010Margaret T. Whitstock No abstract is available for this article. [source] The clinical impact of pharmacogenetics on the treatment of epilepsyEPILEPSIA, Issue 1 2009Wolfgang Löscher Summary Drug treatment of epilepsy is characterized by unpredictability of efficacy, adverse drug reactions, and optimal doses in individual patients, which, at least in part, is a consequence of genetic variation. Since genetic variability in drug metabolism was reported to affect the treatment with phenytoin more than 25 years ago, the ultimate goal of pharmacogenetics is to use the genetic makeup of an individual to predict drug response and efficacy, as well as potential adverse drug events. However, determining the practical relevance of pharmacogenetic variants remains difficult, in part because of problems with study design and replication. This article reviews the published work with particular emphasis on pharmacogenetic alterations that may affect efficacy, tolerability, and safety of antiepileptic drugs (AEDs), including variation in genes encoding drug target (SCN1A), drug transport (ABCB1), drug metabolizing (CYP2C9, CYP2C19), and human leucocyte antigen (HLA) proteins. Although the current studies associating particular genes and their variants with seizure control or adverse events have inherent weaknesses and have not provided unifying conclusions, several results, for example that Asian patients with a particular HLA allele, HLA-B*1502, are at a higher risk for Stevens-Johnson syndrome when using carbamazepine, are helpful to increase our knowledge how genetic variation affects the treatment of epilepsy. Although genetic testing raises ethical and social issues, a better understanding of the genetic influences on epilepsy outcome is key to developing the much needed new therapeutic strategies for individuals with epilepsy. [source] Changes in Quality of Life in Epilepsy: How Large Must They Be to Be Real?EPILEPSIA, Issue 1 2001Samuel Wiebe Summary: ,Purpose: The study goal was to assess the magnitude of change in generic and epilepsy-specific health-related quality-of-life (HRQOL) instruments needed to exclude chance or error at various levels of certainty in patients with medically refractory epilepsy. Methods: Forty patients with temporal lobe epilepsy and clearly defined criteria of clinical stability received HRQOL measurements twice, 3 months apart, using the Quality of Life in Epilepsy Inventory-89 and -31 (QOLIE-89 and QOLIE-31), Liverpool Impact of Epilepsy, adverse drug events, seizure severity scales, and the Generic Health Utilities Index (HUI-III). Standard error of measurement and test-retest reliability were obtained for all scales and for QOLIE-89 subscales. Using the Reliable Change Index described by Jacobson and Truax, we assessed the magnitude of change required by HRQOL instruments to be 90 and 95% certain that real change has occurred, as opposed to change due to chance or measurement error. Results: Clinical features, point estimates and distribution of HRQOL measures, and test-retest reliability (all > 0.70) were similar to those previously reported. Score changes of ±13 points in QOLIE-89, ±15 in QOLIE-31, ±6.3 in Liverpool seizure severity,ictal, ±11 in Liverpool adverse drug events, ±0.25 in HUI-III, and ±9.5 in impact of epilepsy exclude chance or measurement error with 90% certainty. These correspond, respectively, to 13, 15, 17, 18, 25, and 32% of the potential range of change of each instrument. Conclusions: Threshold values for real change varied considerably among HRQOL tools but were relatively small for QOLIE-89, QOLIE-31, Liverpool Seizure Severity, and adverse drug events. In some instruments, even relatively large changes cannot rule out chance or measurement error. The relation between the Reliable Change Index and other measures of change and its distinction from measures of minimum clinically important change are discussed. [source] Pharmacokinetic predictions in children by using the physiologically based pharmacokinetic modellingFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 6 2008F. Bouzom Abstract Nowadays, 50,90% of drugs used in children have never been actually studied in this population. Consequently, either our children are often exposed to the risk of adverse drug events or to lack of efficacy, or they are unable to benefit from a number of therapeutic advances offered to adults, as no clinical study has been properly performed in children. Actually the main methods used to calculate the dose for a child are based on allometric methods taking into account different categories of age, the body weight and/or the body surface area. Unfortunately, these calculation methods consider the children as small adults, which is not the case. Physiologically based pharmacokinetics is one way to integrate the physiological changes occurring in the childhood and to anticipate their impact on the pharmacokinetic processes: absorption, distribution, metabolism and excretion/elimination. From different examples, the application of this modelling approach is discussed as a possible and valuable method to minimize the ethical and technical difficulties of conducting research in children. [source] Inappropriate prescribing in the elderlyJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 2 2007P. Gallagher MB MRCPI Summary Background and objective:, Drug therapy is necessary to treat acute illness, maintain current health and prevent further decline. However, optimizing drug therapy for older patients is challenging and sometimes, drug therapy can do more harm than good. Drug utilization review tools can highlight instances of potentially inappropriate prescribing to those involved in elderly pharmacotherapy, i.e. doctors, nurses and pharmacists. We aim to provide a review of the literature on potentially inappropriate prescribing in the elderly and also to review the explicit criteria that have been designed to detect potentially inappropriate prescribing in the elderly. Methods:, We performed an electronic search of the PUBMED database for articles published between 1991 and 2006 and a manual search through major journals for articles referenced in those located through PUBMED. Search terms were elderly, inappropriate prescribing, prescriptions, prevalence, Beers criteria, health outcomes and Europe. Results and discussion:, Prescription of potentially inappropriate medications to older people is highly prevalent in the United States and Europe, ranging from 12% in community-dwelling elderly to 40% in nursing home residents. Inappropriate prescribing is associated with adverse drug events. Limited data exists on health outcomes from use of inappropriate medications. There are no prospective randomized controlled studies that test the tangible clinical benefit to patients of using drug utilization review tools. Existing drug utilization review tools have been designed on the basis of North American and Canadian drug formularies and may not be appropriate for use in European countries because of the differences in national drug formularies and prescribing attitudes. Conclusion:, Given the high prevalence of inappropriate prescribing despite the widespread use of drug-utilization review tools, prospective randomized controlled trials are necessary to identify useful interventions. Drug utilization review tools should be designed on the basis of a country's national drug formulary and should be evidence based. [source] Model-based cost-effectiveness analysis of interventions aimed at preventing medication error at hospital admission (medicines reconciliation)JOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 2 2009Jonathan Karnon MSc PhD Abstract Rationale, Medication errors can lead to preventable adverse drug events (pADEs) that have significant cost and health implications. Errors often occur at care interfaces, and various interventions have been devised to reduce medication errors at the point of admission to hospital. The aim of this study is to assess the incremental costs and effects [measured as quality adjusted life years (QALYs)] of a range of such interventions for which evidence of effectiveness exists. Methods, A previously published medication errors model was adapted to describe the pathway of errors occurring at admission through to the occurrence of pADEs. The baseline model was populated using literature-based values, and then calibrated to observed outputs. Evidence of effects was derived from a systematic review of interventions aimed at preventing medication error at hospital admission. Results, All five interventions, for which evidence of effectiveness was identified, are estimated to be extremely cost-effective when compared with the baseline scenario. Pharmacist-led reconciliation intervention has the highest expected net benefits, and a probability of being cost-effective of over 60% by a QALY value of £10 000. Conclusions, The medication errors model provides reasonably strong evidence that some form of intervention to improve medicines reconciliation is a cost-effective use of NHS resources. The variation in the reported effectiveness of the few identified studies of medication error interventions illustrates the need for extreme attention to detail in the development of interventions, but also in their evaluation and may justify the primary evaluation of more than one specification of included interventions. [source] Implementation of a patient-friendly medication schedule to improve patient safety within a healthcare systemJOURNAL OF HEALTHCARE RISK MANAGEMENT, Issue 4 2010Jodi E. Fredericks PharmD Preventable adverse drug events have a direct impact on the well-being of patients. The creation and implementation of a patient-friendly daily medication schedule improved the way care is delivered at Memorial Healthcare System. The staff collaborated with patients and families and empowered them with the knowledge and tools needed to make their healthcare safer. Patient and family participation, a critical component of patient- and family-centered care, is a vital part of making healthcare safer. This tool enhances communication with patients and family members and enables patients to better understand the medications they receive while hospitalized. An additional welcomed byproduct is the prevention of potential medication errors. [source] The relationship between computerized physician order entry and pediatric adverse drug events: a nested matched case-control study,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2009Feliciano Yu MD, MSPH Abstract This study assesses the impact of computerized physician order entry (CPOE) implementation in pediatric hospitals on reported adverse drug events. Using a nested matched case-control design; we linked CPOE implementation information from the health information management systems society analytics database with reported adverse drug event (ADE) from the national association of children's hospitals and related institutions case mix comparative data program. Differences were examined using univariate and multivariate conditional logistic regression analyses. Patients from CPOE hospitals were more frequently seen in larger hospitals have more co-morbidities than those from non-CPOE hospitals. When matched by admitting diagnosis, age, gender and race, ADE cases were associated with more reported co-morbidities, and were reported less frequently in hospitals with CPOE. Patients from hospitals without CPOE were 42% more likely to experience reportable ADE after adjusting for the presence of co-morbidities. In conclusion, we found significant beneficial associations between reportable ADE and CPOE adoption in a representative sample of pediatric hospitals. Copyright © 2009 John Wiley & Sons, Ltd. [source] Reliability of the assessment of preventable adverse drug events in daily clinical practice,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2008Jasperien E. van Doormaal PharmD Abstract 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 (,,=,0.34) as well as for the physicians (,,=,0.25). Overall agreement for the 10 raters was fair (,,=,0.25) as well as the agreement between both consensus outcomes (,,=,0.30). Agreement on the occurrence of preventable harm was higher, ranging from ,,=,0.36 for the physicians through ,,=,0.49 for the pharmacists. Overall agreement for the 10 raters was fair (,,=,0.36). The agreement between both consensus outcomes was moderate (,,=,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. Copyright © 2008 John Wiley & Sons, Ltd. [source] Frequency of potential azole drug,drug interactions and consequences of potential fluconazole drug interactions,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 11 2005D. Tony Yu MD Abstract Purpose To assess the frequency of potential azole,drug interactions and consequences of interactions between fluconazole and other drugs in routine inpatient care. Methods We performed a retrospective cohort study of hospitalized patients treated for systemic fungal infections with an oral or intravenous azole medication between July 1997 and June 2001 in a tertiary care hospital. We recorded the concomitant use of medications known to interact with azole antifungals and measured the frequency of potential azole drug interactions, which we considered to be present when both drugs were given together. We then performed a chart review on a random sample of admissions in which patients were exposed to a potential moderate or major drug interaction with fluconazole. The list of azole-interacting medications and the severity of interaction were derived from the DRUGDEX® System and Drug Interaction Facts. Results Among the 4185 admissions in which azole agents (fluconazole, itraconazole or ketoconazole) were given, 2941 (70.3%) admissions experienced potential azole,drug interactions, which included 2716 (92.3%) admissions experiencing potential fluconazole interactions. The most frequent interactions with potential moderate to major severity were co-administration of fluconazole with prednisone (25.3%), midazolam (17.5%), warfarin (14.7%), methylprednisolone (14.1%), cyclosporine (10.7%) and nifedipine (10.1%). Charts were reviewed for 199 admissions in which patients were exposed to potential fluconazole drug interactions. While four adverse drug events (ADEs) caused by fluconazole were found, none was felt to be caused by a drug,drug interaction (DDI), although in one instance fluconazole may have contributed. Conclusions Potential fluconazole drug interactions were very frequent among hospitalized patients on systemic azole antifungal therapy, but they had few apparent clinical consequences. Copyright © 2005 John Wiley & Sons, Ltd. [source] Frequency and nature of drug,drug interactions in a Dutch university hospitalBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2009Jeannette E. F. Zwart-van Rijkom WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , Drug,drug interactions (DDIs) may lead to often preventable adverse drug events and health damage. , In Dutch community pharmacies approximately 6% of all prescriptions generate a DDI alert. , Hospitalized patients may be especially at risk, as they are more severely ill and multiple medications may be prescribed simultaneously; however, only limited data are available on the frequency and nature of DDIs during hospitalization. WHAT THIS STUDY ADDS , In a Dutch university hospital 10% of all prescriptions generated a DDI alert; overall 25% of patients encountered at least one potential DDI. , Besides the risk of decreased effectiveness (25% of the DDIs), the most frequently occurring potential clinical consequence of the DDIs was an increased risk of side-effects, such as an increased bleeding risk (22% of DDIs), hypotension (15%) and nephrotoxicity (13%). , Almost half of the DDIs could be managed by monitoring laboratory values. AIM Drug,drug interactions (DDIs) may lead to often preventable adverse drug events and health damage. Especially within hospitals, this might be an important factor, as patients are severely ill and multiple medications may be prescribed simultaneously. The objective of this study was to measure the frequency and nature of DDI alerts in a Dutch university hospital. METHODS All patients hospitalized in the University Medical Centre Utrecht in 2006 who were prescribed at least one medication were included. The frequency of DDIs was calculated as: (i) the percentage of patients experiencing at least one DDI, and (ii) the percentage of prescriptions generating a DDI alert. Based on the national professional guideline, DDIs were classified into categories of potential clinical outcome, management advice, clinical relevance (A,F) and available evidence (0,4). RESULTS Of the 21 277 admissions included, 5909 (27.8%) encountered at least one DDI. Overall, the prescribing physician received a DDI alert in 9.6% of all prescriptions. The most frequently occurring potential clinical consequence of the DDIs was an increased risk of side-effects such as increased bleeding risk (22.0%), hypotension (14.9%), nephrotoxicity (12.6%) and electrolyte disturbances (10.5%). Almost half (48.6%) of the DDIs could be managed by monitoring laboratory values. CONCLUSIONS Computerized DDI alerts may be a useful tool to prevent adverse drug events within hospitals, but they may also result in ,alert fatigue'. The specificity of alerts could significantly improve by the use of more sophisticated clinical decision support systems taking into account, for example, laboratory values. [source] Evaluation of cost of treatment of drug-related events in a tertiary care public sector hospital in Northern India: a prospective studyBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 3 2009Smita Pattanaik WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , Drug related events include ADRs, events due to patient or physician noncompliance, drug overdosage and drug interactions. , Economic burden of management of drug related events are substantial and include both direct and indirect costs. , Some data regarding cost of treatment of ADR exist from south and western India. WHAT THIS STUDY ADDS , An approximate cost of management of drug related events presenting to the emergency medical department in a tertiary care hospital over a period of 4 months. , Compares the cost incurred in a public sector hospital to the projected cost of management of same events in a private sector hospital. , Gives a rough estimate of economic burden on the health care system due to adverse drug events. AIMS Drug related events (DREs) contribute significantly to hospital admissions. These are largely preventable events and require optimum use of the therapeutic agents. The study was conducted to analyze the cost of treatment of DREs. PATIENTS & METHODS All visits to medical emergency department of a tertiary care public sector hospital in northern India were recorded in a prospective, non-interventional manner over a period of 4 months. DREs were recognized and were followed up till their stay in the hospital. Data about the cost generating components of direct and indirect costs of treatment of DREs were collected. The projected cost of treatment of the same DREs in a private sector hospital was estimated and compared. RESULTS Out of 1833 admissions, 92(5.01%) were due to DREs. Maximum cases were due to non compliance (66%) followed by ADR (28%) and drug overdose(6%). The common DREs leading to ED visits were cerebrovascular accident(19.44%), followed by accelerated hypertension(18.36%) and diabetic ketoacidosis(14.04%). Total cost of management of all the 92 DREs in our hospital was calculated to be INR17,37,339(,30,215). The direct cost was INR1,72,961(,3008) and the approximate indirect cost was INR15,64, 378(,27, 206). The projected cost of management of all the 92 DREs was estimated to be INR63,63,872(,1,01, 676) in a private sector hospital. CONCLUSION The study shows that ADEs leading to emergency department visits and hospitalizations constitute a significant economic burden. Training of the patients and the prescribers may lessen the economic burden on the patient as well as the health care system. [source] | ||||||||||