Winnie W. Nelson

Medication errors involving patient-controlled analgesia

PURPOSE The magnitude, frequency, and nature of nonharmful and harmful medication errors associated with patient-controlled analgesia (PCA) were studied. METHODS A retrospective analysis of Medmarx, a national voluntary medication error-reporting database, was conducted for the period from July 1, 2000, to June 30, 2005, to identify all PCA-related medication errors. Quantitative analysis of the records included the severity of each error, type of error, phase in the medication-use process, principal cause, contributing factors, actions taken, and drug and staff involved. A qualitative analysis was also performed. RESULTS Over the five-year review period, 919,241 medication errors records from 801 facilities were submitted to Medmarx. Of these, 9,571 (1%) were associated with PCA. There were 624 records of PCA associated with harm, corresponding to 6.5% of the patients. Errors were reported across all phases of the medication-use process, but the majority occurred during drug administration. Over one third (38%) involved an improper dosage or quantity, while 17.4% involved an omission and 17.3% an unauthorized or wrong drug. Overwhelmingly, human factors were the main cause of PCA errors. Equipment issues (19.5%) and similar drug names and product packaging (11.6%) were also implicated. Distractions (37.8%) and inexperienced staff (26.3%) were the leading contributing factors. Harmful errors required more institutional resources than nonharmful medication errors to manage. Prescribers often issued incomplete, duplicative, or contradictory orders or failed to adjust dosages for comorbid conditions. Dispensing errors were often associated with misfills from the automated dispensing cabinet, compounding of a wrong strength, or lack of drug product availability. Administration errors involved the wrong drug, amount, or concentration, often because the PCA device was misprogrammed. CONCLUSION Events during all phases of the medication-use process contributed to PCA-related medication errors, many of which harmed patients.

System-Related Events and Analgesic Gaps During Postoperative Pain Management with the Fentanyl Iontophoretic Transdermal System and Morphine Intravenous Patient-Controlled Analgesia

BACKGROUND:Analgesic gaps (interruptions in analgesic delivery) contribute to ineffective postoperative pain management. In this analysis, we evaluated the incidence of analgesic gaps resulting from system-related events (SREs) for patients using the fentanyl iontophoretic transdermal system (ITS), a noninvasive patient-controlled analgesia (PCA) system, or morphine IV PCA for postoperative pain management. METHODS:Data were pooled from two open-label, randomized, active-controlled trials that evaluated the efficacy and safety of fentanyl ITS and morphine IV PCA after total hip replacement, abdominal, or pelvic surgery. The incidence and duration of analgesic gaps resulting from SREs were assessed, along with SRE resolution times. RESULTS:A total of 1305 patients received fentanyl ITS (n = 647) or morphine IV PCA (n = 658). Fentanyl ITS was associated with a significantly lower incidence of analgesic gaps per 100 patients compared with morphine IV PCA (5.87 vs 12.01, respectively; P < 0.001). Compared with patients receiving morphine IV PCA, patients receiving fentanyl ITS had both a numerically lower median total analgesic gap time (15.0 min vs 20.0 min) and a numerically lower median total SRE resolution time (11.0 min vs 20.0 min). Most fentanyl ITS SREs were resolved by applying a new system, whereas many different SRE resolution methods were used for morphine IV PCA. CONCLUSIONS:Fentanyl ITS was associated with a significantly lower incidence of analgesic gaps relative to morphine IV PCA. Fentanyl ITS may provide patients with fewer interruptions and more continuous analgesic delivery.

Patient-Controlled Analgesia-Related Medication Errors in the Postoperative Period: Causes and Prevention

Patient-controlled analgesia (PCA) is a common and effective means of managing postoperative pain. Unfortunately, the complex processes and equipment associated with the setup, programming and administration of intravenous or epidural PCA have allowed it to become a significant source of preventable medication errors. These errors can be classified into two major categories: human (operator) errors and equipment errors (malfunctions). Such errors are potentially harmful to patients, time-consuming for hospital staff and costly for healthcare providers. The objective of this article is to describe PCA medication errors and examine systems and modalities that may help reduce the incidence of system-related errors. Data from the US FDA’s Manufacturer and User Facility Device Experience (MAUDE) database indicate that 6.5% of intravenous PCA-related events were due to operator error. Most (81%) of these errors were due to pump misprogramming, of which almost half were associated with patient harm; 76.4% of adverse events were attributed to device malfunction (e.g. due to frayed wires or a crack in the drug cartridge), although only 0.5% of these were associated with harm to patients. In a report based on data from MEDMARX®, a voluntary database that captures reports on medication errors, 7.9% of the PCA-related errors captured over a 5-year period were described as causing harm to patients. Technological advances, such as improved PCA pump designs based on ergonomic and cognitive engineering principles, the use of barcode technology and other ‘smart pump’ safety features, and new postoperative pain management modalities, may play a significant role in reducing the future incidence and severity of PCA medication errors.

Survey of the use of warfarin and the newer anticoagulant dabigatran in patients with atrial fibrillation

Background Oral dabigatran was recently approved as an alternative to warfarin for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike warfarin, dabigatran has a fixed dosage and few drug interactions, and does not require anticoagulation monitoring or dietary restrictions. Methods This study aimed to describe and compare characteristics of patients with atrial fibrillation who used dabigatran or only warfarin. Patients with a self-reported diagnosis of atrial fibrillation aged ≥18 years who were receiving (or had received) warfarin or dabigatran completed an online survey. Differences in characteristics of dabigatran and warfarin users were tested using chi-squared tests and analysis of variance for categorical and continuous variables, respectively. Results Overall, 364 patients were surveyed (204 warfarin users, 160 dabigatran users). The mean age was 65.1 years, and 68.7% were male. Dabigatran users were more likely than warfarin users to be female (36.9% versus 27.0%) and to have experienced adverse events, including gastrointestinal bleeding, in the 3 months before the survey (21.9% versus 6.9%; P<0.05). Both groups reported high medication adherence (dabigatran users 0.65 versus warfarin users 0.63 missed doses/month). Dabigatran users were more likely than warfarin users to discuss treatment options with their physician before beginning therapy (36.9% versus 24.5%; P<0.05) and less likely to switch anticoagulant medication (10.7% versus 31.9%; P<0.05). Although dabigatran users were more likely to experience adverse events, they reported greater satisfaction with anticoagulation treatment than warfarin users. Conclusion The efficacy and convenience reported by dabigatran users resulted in greater treatment satisfaction among dabigatran users, even though adverse events decreased it. Treatment strategies that minimize adverse events may improve treatment satisfaction and adherence among patients with atrial fibrillation.

Development and validation of a new instrument to evaluate the ease of use of patient-controlled analgesic modalities for postoperative patients

Abstract Objective: To describe the development and psychometric evaluation of a questionnaire assessing the ease of use that patients associate with patient-controlled analgesia (PCA) modalities. Methods: Qualitative interviews were conducted with patients who had experience with intravenous (IV) PCA for postoperative pain management to generate items relevant to the ease of using PCA modalities. The content validity of the resulting questionnaire was examined through follow-up patient interviews, and an expert panel reviewed the questionnaire. Cognitive debriefing interviews were conducted with patients to determine the clarity and content of the instructions, items, and response scales, and the ease of completing the instrument. Psychometric evaluation was performed with patients who had undergone surgery and received IV PCA for postoperative pain management. Item and scale quality and the internal consistency reliability of the questionnaire were assessed. Construct validity was evaluated by examining the relationship between subscales of the questionnaire with patient-reported outcome measures. Known-groups validity was determined by assessing the instruments ability to differentiate between patients with versus without an IV PCA problem. A potential limitation of this study was the exclusive sampling of patients who had experience with IV PCA. Results: The Patient Ease-of-Care (EOC) Questionnaire included 23 items in the following subscales: Confidence with Device, Comfort with Device, Movement, Dosing Confidence, Pain Control, Knowledge/Understanding, and Satisfaction. Coefficient alpha reliability estimates were ≥0.66 for Overall EOC (includes all subscales except Satisfaction) and all EOC subscales. Construct validity was supported by the moderate relationship between the Pain Control subscale and measures of pain severity and pain interference; additional evidence of construct validity was provided by correlations of the Confidence with Device subscale, the Satisfaction subscale, and Overall EOC with measures of pain severity, pain interference, and satisfaction. Significant mean score differences were reported between participants with and without IV PCA problems for Overall EOC and for the Comfort with Device, Confidence with Device, Movement, Pain Control, and Satisfaction subscales indicating known-groups validity. Conclusions: Results provide evidence for the reliability and validity of the Patient EOC Questionnaire as a measure of the ease of use that patients associate with PCA systems and may be useful for evaluating emerging PCA modalities.

Dyspepsia and disease burden among patients with atrial fibrillation.

This retrospective, observational study was conducted to determine overlap of prevalence between atrial fibrillation (AF), an increasingly common condition that primarily affects the elderly population, and dyspepsia, which is also common. Because the overlap of these conditions could interfere with health care including medication selection, the effect on patient outcomes was also evaluated. A demographically representative population of adults in the United States self-administered an Internet-based questionnaire, and responses were evaluated to determine the presence of AF and measures of comorbidity, including CHADS2 score of stroke risk. Health-related quality of life, work productivity and activity impairment, and health care resource utilization were also assessed. The impact of dyspepsia on these patient outcomes was then examined with multiple regressions and generalized linear models. From the sample population, 1297 participants reported being diagnosed with AF, of whom 34% (449/1297) reported diagnosis of dyspepsia. Those with dyspepsia had a higher mean CHADS2 score than those without dyspepsia. Despite this higher risk, significantly fewer AF patients with dyspepsia than those without dyspepsia were taking either prescription medication to treat AF or anticoagulants for stroke prevention. Dyspepsia was associated with significantly lower levels of both mental and physical health-related quality of life. Work and activity impairment and health care resource utilization were also significantly higher among AF patients with dyspepsia than among those without. The burden of dyspepsia in AF patients should be considered during medication selection. Selection of agents associated with lower rates of dyspepsia may lead to greater patient acceptance of and adherence to therapy.

Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review

PURPOSE While corticosteroids are relatively inexpensive and commonly used as treatment for a variety of conditions, long-term use is known to be associated with certain toxicities. Prior systematic reviews have revealed an increased risk for costly adverse events (AEs), including bone fracture, infection, and gastrointestinal bleeding. The objective of this study was to conduct a systematic literature review of recent publications on the burden of long-term corticosteroid exposure, specifically, to summarize the AEs and economic impact of long-term corticosteroid use and to reveal data gaps for additional research. METHODS The Ovid search platform was used to access scientific literature databases. The search strategy targeted the use of corticosteroids and economic outcomes research. Articles were restricted to those published between 2007 and 2016 to cover publications since prior reviews; conference abstracts and articles assessing pediatrics were excluded. Titles and abstracts resulting from inclusion criteria were screened, and reviewers independently extracted relevant information from the relevant full-text articles. FINDINGS The literature review included 32 articles, with 75% focusing on autoimmune diseases, asthma, or lung diseases. Included articles were 14 database analyses, 6 simulations, 6 clinical trials, 3 systematic literature reviews, 2 patient surveys, and 1 chart review. Commonly-cited AEs associated with long-term corticosteroid exposure included hypertension (prevalence >30%); bone fracture (21%-30%); cataract (1%-3%); nausea, vomiting, and other gastrointestinal conditions (1%-5%); and metabolic issues (eg, weight gain, hyperglycemia, and type 2 diabetes; cases had 4-fold the risk of controls). Association of dose and duration with increased AE risk is not well-quantified. AEs like peptic ulcer and myocardial infarction are particularly costly to payers (1-year cost of

The Economic Burden to Medicare of Stroke Events in Atrial Fibrillation Populations With and Without Thromboprophylaxis

21,825 and

Attitudes toward anticoagulant treatment among nonvalvular atrial fibrillation patients at high risk of stroke and low risk of bleed

26,472, respectively, in year-2009 USD). The few articles assessing the economic impact of corticosteroid use have found dose-related increases in health care resource utilization and costs, with per-annum incremental costs relative to nonusers ranging from

Antithrombotic use and bleeding risk in patients with atrial fibrillation: findings from a multipayer analysis

5700 in low-dose users (<7.5 mg/d) to