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Search results for "United States of America"

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Journal Article > Study

Root cause analysis of adverse events in an outpatient anticoagulation management consortium.

Graves CM, Haymart B, Kline-Rogers E, et al. Jt Comm J Qual Patient Saf. 2017;43:299-307.

Anticoagulation confers a high risk of adverse drug events. Examining root cause analyses of anticoagulation–related adverse events, this study found that the majority were not preventable and were due to patient-specific issues. Unlike a prior study, researchers did not include patient perspectives in their analysis, which may have affected their conclusions.

Journal Article > Study

Reducing error in anticoagulant dosing via multidisciplinary team rounding at point of care.

Sharma M, Krishnamurthy M, Snyder R, Mauro J. Clin Pract. 2017;7:953.

Anticoagulants are considered high-risk medications due to their narrow therapeutic window and association with adverse drug events. This study suggests that integration of a clinical pharmacist into the inpatient team may help prevent anticoagulation dosing errors and resultant harm to patients.

Tools/Toolkit > Measurement Tool/Indicator

2017 ISMP Medication Safety Self Assessment® for Antithrombotic Therapy in Hospitals.

Horsham, PA: Institute for Safe Medication Practices; 2017.

This tool provides institutions with the capacity to assess use of antithrombotic agents, submit data to the Institution for Safe Medication Practices for self-assessment scores, compare practices with other hospitals, and allow the development of an ongoing progress report.

Legislation/Regulation > Multi-use Website

National Patient Safety Goals.

Oakbrook Terrace, IL: The Joint Commission; 2017.

The National Patient Safety Goals (NPSGs) have become a critical method by which The Joint Commission promotes and enforces major changes in patient safety. The criteria used for determining the value of these goals, and required revisions to them, are based on the merit of their impact, cost, and effectiveness. Recent changes have focused on preventing hospital-acquired infections and medication errors, in addition to existing goals promoting surgical safety, correct patient identification, communication between staff, and identifying patients at risk for suicide. In 2014, the group added improving the safety of hospital alarm systems, with a plan for a phased implementation of performance measures. For 2017, a new NPSG on catheter-associated urinary tract infections (CAUTI) will apply to nursing care centers, and the NPSGs on CAUTIs for hospitals and critical access hospitals have been revised to apply current evidence.

Press Release/Announcement

Request for comments on the proposed measures and 2020 targets for the National Action Plan for Adverse Drug Event Prevention: inpatient and outpatient measures for reduction of adverse drug events from anticoagulants, diabetes agents, and opioid analgesics.

Federal Register. Washington, DC: Office of Disease Prevention and Health Promotion, US Department of Health and Human Services. October 20, 2016;81:72594-72595.

National attention has focused on efforts to address adverse drug events. This call for comments seeks insights regarding revisions to a 2014 action plan that highlighted how to reduce adverse drug events associated with anticoagulants, diabetes agents, and opioids. These proposed updates involve measures to apply in both the inpatient and outpatient environments to track adverse drug events. The opportunity to submit written comments is now closed.

Journal Article > Study

Inappropriate preinjury warfarin use in trauma patients: a call for a safety initiative.

Hon HH, Elmously A, Stehly CD, et al. J Postgrad Med. 2016;62:73-79.

Warfarin is a recognized high-risk medication that accounts for many hospitalizations due to adverse drug events. This case-control study of patients with traumatic brain injury found that hospital length of stay and mortality were higher among patients taking warfarin compared to those who were not. Additionally, more than 16% of the patients on warfarin may have been taking the medication inappropriately. A WebM&M commentary discusses a case involving a near miss due to inadequate warfarin monitoring.

Journal Article > Review

Predictors of warfarin-associated adverse events in hospitalized patients: opportunities to prevent patient harm.

Metersky ML, Eldridge N, Wang Y, et al. J Hosp Med. 2016;11:276-282.

Anticoagulation medications are often associated with adverse drug events. This study found that less-than-daily monitoring of anticoagulation in hospitalized patients is associated with more frequent out-of-range values, suggesting that daily monitoring is safer.

Journal Article > Study

Improving transitions of care for patients on warfarin: the Safe Transitions Anticoagulation Report.

Dunn AS, Shetreat-Klein A, Berman J, et al. J Hosp Med. 2015;10:615-618.

A formal hospital discharge transition report for patients taking warfarin was well received by outpatient physicians, but it did not appreciably affect processes of care measures or therapeutic efficacy. A postdischarge medication error involving warfarin was discussed in a previous AHRQ WebM&M commentary.

Journal Article > Commentary

Advancing medication safety: establishing a National Action Plan for Adverse Drug Event Prevention.

Harris Y, Hu DJ, Lee C, Mistry M, York A, Johnson TK. Jt Comm J Qual Patient Saf. 2015;41:351-360.

Adverse drug events continue to contribute to preventable errors for both hospitalized and ambulatory patients. This commentary describes the development and implementation plans of a national effort to reduce adverse drug events in the United States.

Newspaper/Magazine Article

Popular blood thinner causing deaths, injuries in nursing homes.

Ornstein C. Washington Post. July 12, 2015.

Anticoagulants are considered high-alert medications that if used ineffectively can result in patient harm. Reporting on an anticoagulant commonly used in nursing homes and patient harm linked to this medication, this newspaper article relates reasons doctors are reluctant to prescribe new drugs to older patients and challenges to monitoring and preventing such adverse drug events.

Legislation/Regulation

Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.

Federal Register. Washington, DC: US Department of Health and Human Services. Baltimore, MD: Food and Drug Administration. July 9, 2015;80:39440-39441.

Heparin is a high-alert anticoagulant that has been associated with patient harm due to issues with administration and contamination. This draft guidance seeks to engage insights from the field to help improve labeling practices. The deadline for officially submitting comments was October 7, 2015.

Journal Article > Study

Anticoagulant medication errors in nursing homes: characteristics, causes, outcomes, and association with patient harm.

Desai RJ, Williams CE, Greene SB, Pierson S, Hansen RA. J Healthc Risk Manag. 2013;33:33-43.

Patients in nursing homes are generally elderly, chronically ill, and take multiple medications, which places them at higher risk for medication errors. The state of North Carolina maintains a mandatory medication error reporting system for all nursing homes. This study analyzed data from this system to characterize errors due to anticoagulant drugs (which are considered high-risk medications). Errors were found to be common and harmful, often due to inadequate monitoring to ensure appropriate drug dosing. The authors recommend several potential solutions, but any interventions will likely also have to address the fact that safety culture in nursing homes is generally poor. An AHRQ WebM&M commentary discusses a preventable error due to inadequate monitoring of the anticoagulant warfarin at a nursing home, and an AHRQ WebM&M perspective explores the difficult problem of ensuring medication safety in nursing facilities.

Journal Article > Commentary

Delivery of optimized inpatient anticoagulation therapy: consensus statement from the Anticoagulation Forum.

Nutescu EA, Wittkowsky AK, Burnett A, Merli GJ, Ansell JE, Garcia DA. Ann Pharmacother. 2013;47:714-724.

Anticoagulant medications are considered among the highest-risk medications in common use, due to the potential for serious bleeding complications if medication errors occur. As a result, ensuring anticoagulant safety is one of the National Patient Safety Goals. This consensus statement provides guidelines for developing safer systems for the appropriate prescribing, administration, and monitoring of anticoagulant drugs in the hospital setting, as well as for minimizing adverse events after hospital discharge in patients receiving these medications. A serious medication error due to incorrect dosing of warfarin is discussed in an AHRQ WebM&M commentary.

Press Release/Announcement

Important change to heparin container labels to clearly state the total drug strength.

MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; December 6, 2012.

This announcement describes a labeling change designed to prevent calculation errors associated with heparin, a high-alert medication.

Journal Article > Study

Dementia and risk of adverse warfarin-related events in the nursing home setting.

Tjia J, Field TS, Mazor KM, et al. Am J Geriatr Pharmacother. 2012;10:323-330.

Dementia appeared to be an independent risk factor for medication errors among a cohort of geriatric nursing home patients who were prescribed the anticoagulant warfarin. Increased nursing staff time seemed to mitigate this risk.

Journal Article > Study

Anticoagulation-associated adverse drug events.

Piazza G, Nguyen TN, Cios D, et al. Am J Med. 2011;124:1136-1142.

Warfarin and other anticoagulant medications place patients, especially elderly ones, at high risk of adverse drug events (ADEs) due to their narrow therapeutic window. This retrospective analysis of anticoagulant-related ADEs at an academic medical center identified the underlying cause of these events and found evidence that a large proportion should be preventable. More than two-thirds of anticoagulant-related ADEs were attributable to medication errors, usually at the medication administration stage. A large proportion of the errors were ascribed to incorrect transcription of orders. The persistent incidence of transcription errors in this study is especially surprising given that the hospital in question already had a computerized provider order entry (CPOE) system. Fully electronic closed-loop medication systems, which integrate CPOE, barcoding, and electronic medication administration records, hold promise as a means of reducing both transcribing and administration errors.

Journal Article > Study

Provider and pharmacist responses to warfarin drug–drug interaction alerts: a study of healthcare downstream of CPOE alerts.

Miller AM, Boro MS, Korman NE, Davoren JB. J Am Med Inform Assoc. 2011;18(suppl 1):i45-i50.

This study highlights the role of alert fatigue and provider overrides in contributing to warfarin-related adverse drug events.

Journal Article > Study

Novel analysis of clinically relevant diagnostic errors in point-of-care devices.

Shermock KM, Streiff MB, Pinto BL, Kraus P, Pronovost PJ. J Thromb Haemost. 2011;9:1769-1775.

In this study, investigators compared international normalized ratio measurements (INR, a measurement of blood clotting ability) obtained simultaneously on a point-of-care analyzer and a standard blood draw. Although the concordance between the two measurements met traditional quality assurance standards, the point-of-care analyzer results were systematically biased toward normal measurements, putting patients at risk of preventable adverse events due to failure to adjust anticoagulant medications appropriately.

Journal Article > Study

Adopting real-time surveillance dashboards as a component of an enterprisewide medication safety strategy.

Waitman LR, Phillips IE, McCoy AB, et al. Jt Comm J Qual Patient Saf. 2011;37:326-332.

Adverse drug event surveillance is an important strategy to both identify and prevent medication errors, particularly for high-risk medications. This study reports on the development of a real-time surveillance dashboard to enable pharmacy review of high-alert medication orders and complement a system already using computerized provider order entry and clinical decision support. Of nearly 30,000 hospitalizations studied, there were more than 2200 that involved exposure to warfarin, 8300 to heparin or enoxaparin, and 890 to aminoglycosides. Real-time pharmacy review of the dashboard provided a vehicle to prevent medication errors or optimize therapy; for example, 55% of patients receiving aminoglycosides did not have a baseline creatinine. The authors argue that even sophisticated computerized systems require active surveillance systems to leverage technology and provide necessary medication safety.

Journal Article > Study

Clinical and safety impact of an inpatient pharmacist-directed anticoagulation service.

Schillig J, Kaatz S, Hudson M, Krol GD, Szandzik EG, Kalus JS. J Hosp Med. 2011;6:322-328.

Patients receiving warfarin therapy are at high risk for adverse events. Interventions to improve warfarin safety have focused on trigger tools, communication protocols, and the use of visual medication schedules. This study implemented a pharmacist-directed anticoagulation service to capture inpatients on warfarin and provide them with dosing, monitoring, and coordination of transition from the inpatient to outpatient setting. This cluster randomized trial demonstrated safer transitions in 73% more patients and a 32% reduction in the composite safety end point, which was driven by fewer patients experiencing an INR ≥ 5 (i.e., supratherapeutic levels that increase the risk of bleeding). This study adds further support to the role of pharmacists in driving medication safety, specifically for warfarin in both the inpatient and community settings. A past AHRQ WebM&M commentary discussed a case of a near miss due to a warfarin drug interaction that led to a supratherapeutic level following hospital discharge.

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