Nature Of Adverse Events Research Articles

Fatalities after CAM: an overview

Many practitioners of complementary and alternative medicine (CAM) and most patients seem to believe that CAM is almost totally devoid of risks. Critical observers, however, should know better. There are numerous risks and some of them can be serious. In this overview, I very briefly summarise reports of fatalities that have occurred after acupuncture, EDTA-chelation therapy, and chiropractic. This article is based on three recently published systematic reviews.1–3 It is aimed at highlighting the rare but potentially serious nature of adverse events after CAM. A systematic review included 86 instances of deaths after acupuncture.1 Many of the primary reports were incomplete, and causality was often less than certain. The most frequent causes of death were pneumothorax; puncture of the heart, large blood vessel, central nervous system, or liver; and various types of (mostly bacterial) infections. The majority of the reports originated from China, Japan and other Asian countries. Others came from Germany, Norway, and the US. In CAM EDTA-chelation therapy is sometimes advocated for cardiovascular diseases such as claudicatio intermittens . A systematic review summarised all deaths after EDTA-chelation therapy reported …

Progress in Pediatric Sedation Research

The practice of pediatric sedation continues to evolve, largely based on data that are produced by researchers in this field. This article reviews notable recent trends in research as reported in peer-reviewed journals, including large prospective database studies that have improved our understanding of the incidence and nature of adverse events in pediatric sedation. Along with this effort has come an attempt to better develop a new lexicon to describe “adverse events” or complications. In addition to these descriptive demographic articles, investigators continue to add to the cumulative experience with new drugs such as dexmedetomidine and older sedatives/analgesics such as ketamine and nitrous oxide in children. Finally, evaluation of the workload and trends in sedation utilization in children have been reported and will be reviewed; and future needs for pediatric sedation research are suggested.

Relief of Periorbital Pain After Acute Angle Closure Glaucoma Attack by Botulinum Toxin Type A

To assess the efficacy and safety of botulinum toxin type A (BoNT-A) injection in patients suffering from intractable periorbital pain after acute angle closure glaucoma (AACG). In this prospective randomized intervention study, 19 patients suffering from periorbital pain after an AACG attack were injected with BoNT-A or placebo for pain relief. Patients were assessed on days 1, 2, 7, 14, 30, 60, and 90. The main outcomes were mean change of visual analog rating scale (VARS) and index scores measured through a quality-of-life questionnaire (EQ-5D), and changes in the visual analog scale (VAS), all of which were assessed at each visit. A secondary outcome was the frequency and nature of adverse events and the number of patients who withdrew from the study as a result. In the treatment group (n=10), the mean index score of EQ-5D and VAS changed significantly from the placebo group (by 0.299 and 2.61, respectively) from day 2 (P<0.01). The VARS of EQ-5D also disclosed significant changes from day 2 (17, P<0.01). In addition, efficacy was maintained mainly between days 2 and 60 but declined slightly by day 90. The most frequently reported treatment-related adverse events in the treatment and placebo groups were local tenderness (21%), subcutaneous hemorrhage (10.5%), and conjunctivitis (10.5%). No severe adverse events were reported during the study or follow-up period. BoNT-A is effective and well tolerated for the treatment of periorbital pain after an AACG attack. Its effects may be maintained for 3 months.

Spotlight on Strontium Ranelate†

This is a review of the pharmacology of strontium ranelate (Protelos, Protos, Protaxos, Bivalos, Osseor), and its efficacy and tolerability in the treatment of patients with postmenopausal osteoporosis. Strontium ranelate is a divalent strontium salt of ranelic acid that is capable of increasing bone formation and reducing bone resorption, thereby uncoupling and rebalancing bone turnover in favour of bone formation. The drug is effective in reducing the risk of fractures, including both vertebral and nonvertebral fractures, in patients with postmenopausal osteoporosis, according to data from two large, double-blind, placebo-controlled, multicentre trials of 5 years' duration, and reduced the risk of hip fracture in high-risk patients in a post hoc analysis of one trial. Moreover, data from patients who continued to receive the drug during the 3-year extension phase of these trials indicate that strontium ranelate continues to provide protection against new vertebral fractures and nonvertebral fractures for up to 8 years of therapy. It also improves bone mineral density at numerous sites and both increases markers of bone formation and decreases markers of bone resorption. Strontium ranelate is administered orally as a suspension and is generally well tolerated. The nature of adverse events was generally similar regardless of treatment duration in clinical trials, with the most commonly reported being nausea and diarrhoea over 5 years of treatment, and memory loss and diarrhoea during longer-term treatment. Although an increased risk of venous thromboembolism was associated with strontium ranelate relative to placebo over 5 years of treatment in a pooled analysis of clinical trials, postmarketing data have not confirmed this finding. Overall, the clinical data available suggest that strontium ranelate is an effective and generally well tolerated option for the first-line treatment of postmenopausal osteoporosis.

Patient Safety in the Operating Theatre

The aim of this symposium is to present and discuss recent research on the factors shaping safe and efficient performance in the operating theatre. Ten years ago, it was not generally accepted that a significant number of surgical patients were harmed not as a result of underlying illness or disease but as a result of their treatment. Detailed incident analyses and studies of behavior in the operating theatre revealed that factors such as decision making, situation awareness, coordination and leadership play a contributory role in the multifaceted nature of adverse events. The papers included in this symposium address these issues applying a spectrum of theoretical and methodological approaches. The emergent findings of these studies have important implications for future research as well as training and organizational design. For design recommendations to be useful in clinical practice they require an in-depth understanding of the strengths and vulnerabilities pertaining to the clinical work environment. This is reflected by the fact that this symposium brings together teams of clinicians and human factors experts in discussing their most recent research.

Use of an electronic information system to identify adverse events resulting in an emergency department visit

ObjectiveThere is limited information about the nature of adverse events (AEs) that necessitate an emergency department (ED) visit. The objective of the current study was to demonstrate the feasibility of...

Comparison of the analgesic efficacy of concurrent ibuprofen and paracetamol with ibuprofen or paracetamol alone in the management of moderate to severe acute postoperative dental pain in adolescents and adults: A randomized, double-blind, placebo-controlled, parallel-group, single-dose, two-center, modified factorial study

Background: Combination analgesics may offer improved analgesic efficacy, particularly for moderate to severe pain. Objective: This study evaluated the analgesic benefits of concurrent ibuprofen and paracetamol compared with each drug used alone in the management of acute postoperative dental pain. Methods: Healthy patients aged 16 to 40 years undergoing surgical removal of 3 to 4 impacted molars (total impaction score ≥9) were enrolled in this randomized, double-blind, placebo-controlled, parallel-group, single-dose, 2-center, modified factorial US study. Patients were randomly assigned in a ratio of 2:1:2:1:1 to ibuprofen 400 mg/paracetamol 1000 mg, ibuprofen 200 mg/ paracetamol 500 mg, ibuprofen 400 mg, paracetamol 1000 mg, or placebo when postoperative pain reached moderate to severe intensity. The primary efficacy end point was the sum of pain relief and pain intensity differences from 0 to 8 hours (SPRID8). Several secondary end points were also measured, including total pain relief (TOTPAR), sum of pain intensity differences (SPID), and SPID on the visual analog scale (SPID VAS) at various time points. Other analgesic efficacy measures included peak effect, onset and duration of effect, and patients' overall assessment of treatment. The tolerability of study medications was assessed in terms of the frequency and nature of adverse events, which were assessed with standard questions, as well as changes from baseline in vital signs. Results: A total of 234 patients were randomly assigned to treatment and included in the intent-to- treat population. The patients were predominantly female (74.4% [174/234]) and white (76.5% [179/234]); mean (SD) age was 20.8 (3.1) years and weight was 69.1 (16.5) kg. For SPRID8, the group treated with ibuprofen 400 mg/paracetamol 1000 mg had significantly better mean scores compared with ibuprofen alone (P < 0.001), paracetamol alone (P < 0.001), and ibuprofen 200 mg/paracetamol 500 mg (P = 0.02). The group taking ibuprofen 200 mg/paracetamol 500 mg achieved significantly better mean SPRID8 scores than paracetamol alone (P = 0.03), but not ibuprofen alone (P = NS). Ibuprofen 400 mg/paracetamol 1000 mg was associated with significantly better scores than was single-agent therapy for TOTPAR, SPID, and SPID VAS at all time intervals and for SPRID from 4 to 6 hours (all, P < 0.001). Pairwise comparisons found statistically significant differences in favor of all active treatments versus placebo for virtually all efficacy end points, thereby supporting assay sensitivity. Adverse events were similar across treatments; the most frequent were nausea (26.1% [61/234]), vomiting (18.8% [44/234]), headache (10.3% [24/234]), and dizziness (8.1% [19/234]). Conclusion: Concurrent ibuprofen and paracetamol appeared to provide significantly better analgesic efficacy compared with ibuprofen or paracetamol alone for acute postoperative dental pain in these adolescents and

Strontium Ranelate

This is a review of the pharmacology of strontium ranelate (Protelos, Protos, Protaxos, Bivalos, Osseor), and its efficacy and tolerability in the treatment of patients with postmenopausal osteoporosis. Strontium ranelate is a divalent strontium salt of ranelic acid that is capable of increasing bone formation and reducing bone resorption, thereby uncoupling and rebalancing bone turnover in favour of bone formation. The drug is effective in reducing the risk of fractures, including both vertebral and nonvertebral fractures, in patients with postmenopausal osteoporosis, according to data from two large, double-blind, placebo-controlled, multicentre trials of 5 years' duration, and reduced the risk of hip fracture in high-risk patients in a post hoc analysis of one trial. Moreover, data from patients who continued to receive the drug during the 3-year extension phases of these trials indicate that strontium ranelate continues to provide protection against new vertebral fractures and nonvertebral fractures for up to 8 years of therapy. It also improves bone mineral density at numerous sites and both increases markers of bone formation and decreases markers of bone resorption. Strontium ranelate is administered orally as a suspension and is generally well tolerated. The nature of adverse events was generally similar regardless of treatment duration in clinical trials, with the most commonly reported being nausea and diarrhoea over 5 years of treatment, and memory loss and diarrhoea during longer-term treatment. Although an increased risk of venous thromboembolism was associated with strontium ranelate relative to placebo over 5 years of treatment in a pooled analysis of clinical trials, postmarketing data have not confirmed this finding. Overall, the clinical data available suggest that strontium ranelate is an effective and generally well tolerated option for the first-line treatment of postmenopausal osteoporosis.

Final Results of a Randomized Phase II Study Demonstrating Efficacy and Safety of BSI-201, a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor, in Combination with Gemcitabine/Carboplatin (G/C) in Metastatic Triple Negative Breast Cancer (TNBC).

Abstract Background: TNBC is an aggressive breast cancer subtype which shares molecular and pathologic features with BRCA1-related breast cancers. BRCA-deficient cells are sensitive to inhibition of PARP1, a critical enzyme of cell proliferation and DNA repair, and thus represent a rational target of PARP inhibitor-based cancer therapy. The objectives of this study were to evaluate BSI-201, a potent PARP1 inhibitor, in combination with G/C in subjects with metastatic TNBC. Methods: Eligible subjects had measurable disease and received ≤2 prior cytotoxic regimens for ER-, PR-, and HER2-negative metastatic breast cancer. Patients were randomized (1:1) to G/C alone or G/C + BSI-201. Gemcitabine (1000 mg/m2; IV) and carboplatin (AUC = 2; IV) were given on days 1 and 8, and BSI-201 (5.6 mg/kg; IV) on days 1, 4, 8, and 11 every 21 days. Endpoints were clinical benefit rate (CBR = CR + PR + SD ≥6 months), objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results: Preliminary analyses of all 116 dosed patients showed that, based on all patient visits through March 2009, BSI-201 + G/C improved CBR, ORR, median PFS, and median OS, compared with G/C alone. The frequency and nature of adverse events did not differ between arms. G/CG/C+BSI-201Hazard Ratio (n=57)(n=59)(95% CI)P valueCBR, %2162 0.0002ORR, %1648 0.002Median PFS, months3.36.90.34 (0.20-0.58)&amp;lt;0.0001Median OS, months5.79.20.35 (0.19-0.65)0.0005 Conclusions: This analysis demonstrates that BSI-201 + G/C improved patient's outcomes, as measured by CBR, ORR, PFS and OS, compared with G/C alone. BSI-201 + gemcitabine/carboplatin was well tolerated and did not potentiate chemotherapy-related toxicities. Final data on CBR and ORR, as well as updated analyses of PFS and OS for all 116 dosed patients will be presented based on all patient visits through September 2009. Exploratory correlative analyses of PARP expression and overall clinical response will also be presented, as well as initial correlative analyses between number of metastatic therapies and clinical response. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 3122.

Pediatric Safety of Tizanidine

Tizanidine is an imidazoline with central alpha(2)-adrenoceptor agonist activity at both spinal and supraspinal levels, which is indicated as a short-acting drug for the management of spasticity. Despite being used in pediatric populations, there is no adequate information or well controlled studies to document the safety and efficacy of tizanidine in this group. To evaluate the safety of tizanidine in the pediatric population. We compared spontaneous adverse event reports in the Acorda Therapeutics worldwide clinical adverse event database for children (< or = 16 years; n = 99) and adults (>16 years; n = 1153) who had received tizanidine and for whom at least one adverse event was reported, and performed a retrospective chart review of the safety of tizanidine in children (< or = 16 years; n = 76) at a large US pediatric neurology practice. Causality of adverse events in our worldwide clinical adverse event database were neither assessed nor assigned by the company. When adverse events from the clinical adverse event database were collapsed into the 25 Medical Dictionary for Regulatory Activities (MedDRA; version 9.0) organ system classes, five classes were more frequent in adults (general disorders and administration site conditions [p = 0.0006], hepatobiliary disorders [p = 0.0031], nervous system disorders [p = 0.0108], skin and subcutaneous disorders [p = 0.0063], and vascular disorders [p = 0.0029]), while one class was more frequent in children (psychiatric disorders [p < 0.0001]). The most common adverse event classes in children were psychiatric disorders (52.5%) followed by nervous system disorders (29.3%), and gastrointestinal disorders (16.2%), whereas the most common adverse event classes in adults were nervous system disorders (42.4%), general disorders and administration site conditions (28.6%), and gastrointestinal disorders (21.3%). Serious adverse events were substantially less frequent in children than adults (19.2% vs 45.9%) in the clinical adverse event database. In the pediatric practice chart review, the incidence of adverse events in the MedDRA psychiatric disorders class was very similar (52.6%) to that for children in the clinical adverse event database, while the next most common classes were gastrointestinal disorders (14.5%), and nervous system disorders (13.2%). There were three deaths in children across the databases, including one from accidental exposure and two from cardiac events; the relationship of cardiac events in relation to tizanidine or other causes was difficult to assess with the limited available information.The major causes of death in adults were related to suicide or overdose. Minor, transient liver transaminase increases were occasionally reported; the effect of tizanidine could not be ruled out. The overall safety of tizanidine in the pediatric group appeared good; however, the adverse event profile differed from that in adults. This difference most likely reflects the off-label use of tizanidine as adjunctive treatment for attention disorders and autism. The frequency and nature of adverse events in adults were consistent with the tizanidine prescribing information as reported for its approved indication, i.e. management of spasticity.

The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia With Propofol for Procedures Outside the Operating Room

The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia With Propofol for Procedures Outside the Operating Room

Risk and safety of pediatric sedation/anesthesia for procedures outside the operating room

Sedation and anesthesia outside the operating room represents a rapidly growing field of practice that involves a number of different specialty providers including anesthesiology. The literature surrounding this work is found in a variety of journals - many outside anesthesiology. This review is intended to inform readers about the current status of risk and safety involving sedation/anesthesia for tests and minor procedures utilizing a wide range of sources. Two large database studies have helped to define the frequency and nature of adverse events in pediatric sedation/anesthesia practice from a multispecialty perspective. A number of papers describing respiratory and hemodynamic aspects of dexmedetomidine sedation have also been published. Finally, a number of studies relating to training sedation providers, reporting of sedation adverse events, sedation for vulnerable populations, and (in particular) ketamine sedation adverse respiratory events have also come to light. The latest publications continue to document a relatively low risk to pediatric sedation yet also warn us about the potential adverse events in this field. The results help to define competencies required to deliver pediatric sedation and make this practice even safer. Particularly interesting are new jargon and methodologies for defining adverse events and the use of new methods for training sedation providers.

Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial

3 Background: TNBC is an aggressive breast cancer subtype that shares molecular and pathologic features with BRCA1-related breast cancers. BRCA-deficient cells are sensitive to inhibition of PARP1, a critical enzyme of cell proliferation and DNA repair, and thus represent a rational target of PARP inhibitor-based cancer therapy. The objectives of this study were to evaluate BSI-201, a potent PARP1 inhibitor, in combination with gemcitabine/carboplatin (G/C) in subjects with metastatic TNBC. Methods: Eligible subjects had measurable disease and had ≤2 prior cytotoxic regimens for ER-, PR-, and HER2-negative metastatic breast cancer. Patients were randomized (1:1) to G/C alone or G/C + BSI-201. Gemcitabine (1000 mg/m2) and carboplatin (AUC=2) were given on days 1 and 8, and BSI-201 (5.6 mg/kg; iv; biweekly) on days 1, 4, 8, and 11 every 21 days. Endpoints were clinical benefit rate (CBR = CR + PR + SD ≥6 months), progression-free survival (PFS) and overall survival (OS). Results: Analyses of the first 86 of a planned 120 patients showed that BSI-201 + G/C had improved CBR, median PFS, and median OS, compared with G/C alone. The frequency and nature of adverse events (AEs) did not differ between arms. Conclusions: This preliminary analysis demonstrates that BSI-201 + G/C significantly improves CBR, PFS, and OS, compared with G/C alone. BSI-201 + G/C was well tolerated, with BSI-201 adding no significant toxicity to G/C. Updated CBR, PFS, and OS for all 120 patients and exploratory correlative analyses of PARP expression and clinical response will be presented. [Table: see text] [Table: see text]

Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial

3 Background: TNBC is an aggressive breast cancer subtype that shares molecular and pathologic features with BRCA1-related breast cancers. BRCA-deficient cells are sensitive to inhibition of PARP1, a critical enzyme of cell proliferation and DNA repair, and thus represent a rational target of PARP inhibitor-based cancer therapy. The objectives of this study were to evaluate BSI-201, a potent PARP1 inhibitor, in combination with gemcitabine/carboplatin (G/C) in subjects with metastatic TNBC. Methods: Eligible subjects had measurable disease and had ≤2 prior cytotoxic regimens for ER-, PR-, and HER2-negative metastatic breast cancer. Patients were randomized (1:1) to G/C alone or G/C + BSI-201. Gemcitabine (1000 mg/m2) and carboplatin (AUC=2) were given on days 1 and 8, and BSI-201 (5.6 mg/kg; iv; biweekly) on days 1, 4, 8, and 11 every 21 days. Endpoints were clinical benefit rate (CBR = CR + PR + SD ≥6 months), progression-free survival (PFS) and overall survival (OS). Results: Analyses of the first 86 of a planned 120 patients showed that BSI-201 + G/C had improved CBR, median PFS, and median OS, compared with G/C alone. The frequency and nature of adverse events (AEs) did not differ between arms. Conclusions: This preliminary analysis demonstrates that BSI-201 + G/C significantly improves CBR, PFS, and OS, compared with G/C alone. BSI-201 + G/C was well tolerated, with BSI-201 adding no significant toxicity to G/C. Updated CBR, PFS, and OS for all 120 patients and exploratory correlative analyses of PARP expression and clinical response will be presented. G/C (n = 44) G/C+BSI−201 (n = 42) Hazard ratio (95% CI) P value CBR, % 12 52 0.0012 Median PFS, days 87 211 0.30 (0.15–0.59) 0.0003 Median OS, days 169 >254 0.24 (0.09–0.61) 0.0012 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration BiPar Sciences, Inc.

Ambulance stretcher adverse events

Introduction:Ambulance personnel use wheeled stretchers for moving patients in the out-of-hospital setting. The nature of adverse events and associated injuries occurring during ambulance stretcher operation was characterised.Methods:Data from the United...

GS20 *ADVERSE EVENTS IN GENERAL SURGERY

Background: The rate of adverse events occurring in Australian hospitals is reported to be up to 12–17%. Adverse events need to be identified, reported and responded to if the system of health care is to be improved. The purpose of this study was to determine the rate and nature of adverse events (unintentional harm arising as a result of healthcare) in general surgery in the Geelong Hospital.Method: A review was conducted of adverse events in the hospital incident reporting system (Riskman) and general surgical audits between 2004 and 2008. Adverse events were categorised according to severity (1–4) and the hospital response to these events noted.Results: There were 888 adverse events arising in 12801 general surgical admissions (6.93%). Their severity assessment codes (SAC) were: catastrophic (0.15%),; major (0.40%),; moderate (2.22%),; and minor (4.30). Some of the complications reported in surgical audits were also adverse events, the major ones being mortality (0.74%), unplanned reoperation (1.27%) and unplanned readmission (1.46%). Identification and tracking of these enabled implementation of system changes. These included a colorectal outcome reporting, PreVENT program (for DVT prophylaxis), review of colonoscopy initiatives, bedside tracheostomy care, and an electronic system to respond to pathology results (TR3).Conclusion: The adverse event rates occurring in general surgery at the Geelong Hospital were lower than those previously reported in the literature and may reflect a general improvement in the quality of care during the last decade if these rates are applicable to other hospitals. The hospital response to adverse events has resulted in significant sustainable system changes.

The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia With Propofol for Procedures Outside the Operating Room: A Report From the Pediatric Sedation Research Consortium

We used a large database of prospectively collected data on pediatric sedation/anesthesia outside the operating room provided by a wide range of pediatric specialists to delineate the nature and frequency of adverse events associated with propofol-based sedation/anesthesia care. Data were collected by the Pediatric Sedation Research Consortium, a collaborative group of institutions dedicated to improving sedation/anesthesia care for children internationally. Members prospectively enrolled consecutive patients receiving sedation or sedation/anesthesia for procedures. The primary inclusion criterion was the need for some form of sedation/anesthesia to perform a diagnostic or therapeutic procedure outside the operating room. There were no exclusion criteria. Data on demographics, primary illness, coexisting illness, procedure performed, medications used, procedure and recovery times, medication doses outcomes of anesthesia, airway interventions and adverse events were collected and reported using web-based data collection tool. For this study, we evaluated all instances where propofol was used as the primary drug in the sedation/anesthesia technique. Thirty-seven locations submitted data on 49,836 propofol sedation/anesthesia encounters during the study period from July 1, 2004 until September 1, 2007. There were no deaths. Cardiopulmonary resuscitation was required twice. Aspiration during sedation/anesthesia occurred four times. Less serious events were more common with O(2) desaturation below 90% for more than 30 s, occurring 154 times per 10,000 sedation/anesthesia administrations. Central apnea or airway obstruction occurred 575 times per 10,000 sedation/anesthesia administrations. Stridor, laryngospasm, excessive secretions, and vomiting had frequencies of 50, 96, 341, and 49 per 10,000 encounters, respectively. Unexpected admissions (increases in levels of care required) occurred at a rate of 7.1 per 10,000 encounters. In an unadjusted analysis, the rate of pulmonary adverse events was not different for anesthesiologists versus other providers. We report the largest series of pediatric propofol sedation/anesthesia for procedures outside the operating room. The data indicate that propofol sedation/anesthesia is unlikely to yield serious adverse outcomes in a collection of institutions with highly motivated and organized sedation/anesthesia services. However, the safety of this practice is dependent on a system's ability to manage less serious events. We propose that our data suggest variables for training and credentialing providers of propofol sedation/anesthesia and the system characteristics that promote safe use of this drug.

Efficacy of clinical laboratory: Therapeutic TAT, safety, and medical errors

Health care services rely on continued technological advances and management of the operational systems for optimum reduction of medical errors. Significant gains in health care outcomes as indicated by recorded increases in life expectancies have been achieved due to the availability and application of technological advances for medical services. The inadequacies in the application of these systems for maximum benefit of the health care systems have however been the subject of recent publications dealing with patient safety and medical errors [Kohn Linda T, Corrigan Janet M, Donaldson Molla S, editors. To err is human: building a safer health system. Washington, DC: Institute of Medicine, National Academy Press; 2000; Brennan TA, Leape LL. Adverse events, negligence in hospitalized patients: results from the Harvard Medical Practice Study. Perspect Healthc Risk Manage 1991;11(2):2–8; Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. New Engl J Med 1991;324(6):377–84; Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000;38(3):261–71]. Estimates by the Institute of Medicine (IOM) indicate that approximately 44,000–98,000 deaths occur each year as a consequence of inadequate safety and failure to prevent errors in the health care system. This puts medical errors in the top four leading causes of deaths per the IOM report. Other studies in the USA states of Colorado, Utah, and New York suggest that medical errors occur in 2–4% of hospitalizations. The paper by Raab et al. denoted a 6.7% discrepancy between original report and secondary case review, and 5% of the discrepancies have modest to significant effect on patient care [Raab SS, Grzybicki DM, Zarbo RJ, Meier FA, Geyer SJ, Jensen C. Anatomic pathology databases and patient safety. Arch Pathol Lab Med 2005;129:459–66]. This presentation focuses on the health care safety and medical errors relative to clinical laboratory. The impact of laboratory operations with resultant delays in test turn around times (TAT) and other laboratory errors on the health care services are presented. The role of governmental (US Department of Health and Human Services) and non-governmental regulatory agencies (CAP, AACC, IFCC, CLSI, etc) in mitigating these clinical laboratory errors is discussed. The use of payment system as a mechanism for improving the quality of laboratory services is also presented to illustrate the checks and balance systems aimed at reduction of medical errors. The presentation will conclude with the recommendation that majority of the clinical laboratory delays in turn around time and other errors can be prevented with appropriate analytical systems and operational processes under the overall guidance of the right regulatory agencies.

Complications of Modern Diagnostic Cerebral Angiography in an Academic Medical Center

Catheter cerebral angiography and noninvasive cerebral imaging have steadily improved in the past several decades. Now, catheter angiography is frequently reserved for treatment planning. To remain relevant as a diagnostic modality, catheter angiography must be safe, even in critically ill patients. The present report describes the complication rate of catheter cerebral angiography performed by neurointerventional specialists at an academic medical center. From July 2001 through June 2007, 3,636 diagnostic catheter cerebral angiograms were obtained at a large academic institution. Complication data were prospectively acquired according to institutional policy and New York Patient Occurrence Reporting and Tracking System criteria. Data collected included patient age, sex, indication for the procedure, operator, and nature of adverse event, including need for treatment. Clinical predictors of complications were evaluated with logistic regression. Among 3,636 diagnostic cerebral angiograms obtained in 6 years, there were 11 clinical complications (0.30%). One patient (0.03%) had magnetic resonance imaging-detected stroke with no apparent clinical deterioration. Iatrogenic dissections were seen in five arteries (0.14%). No patient developed neurologic symptoms. Nonneurologic complications occurred in five patients (0.14%) who had arteriotomy site-related complications: one femoral abscess, two occlusions of the femoral artery with leg ischemia requiring surgical revascularization, one dissection with pseudoaneurysm formation requiring percutaneous thrombin injection, and one retroperitoneal hemorrhage requiring transfusion. Three of these patients were treated with an arterial closure device. Age greater than 65 years was associated with development of complications (P = .03). Modern catheter cerebral angiography performed by neurointerventionalists is associated with a low complication rate of 0.30%, even in a highly complex patient population.

Epidemiology and nature of adverse events in the ICU

Critically ill patients require high-intensity care may be at especially high risk of iatrogenic injury because they are severely ill [1]. We sought to study the incidence and nature of adverse events in the critical care setting.