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- Study 6
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- Legislation/Regulation 2
- Newspaper/Magazine Article 8
- Toolkit 2
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- Press Release/Announcement 27
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Education and Training
- Students 1
Error Reporting and Analysis
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- Identification Errors 1
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- Medication Errors/Preventable Adverse Drug Events
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United States of America
United States Federal Government
- Department of Health and Human Services (HHS) 70
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Search results for "Government Resource"
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.
Silver Spring, MD: US Food and Drug Administration; April 9, 2019.
Efforts to address the opioid epidemic range from regulation to changes in pain management. This safety announcement raises awareness of potential harms associated with rapidly decreasing the dose of or discontinuing opioids for patients who may be physically dependent on the medication. It also announces a requirement regarding changes to prescribing information for opioids to provide expanded guidance on how to safely taper doses. Health care providers should discuss tapering plans with patients and provide ongoing monitoring and support.
AHRQ National Scorecard on Hospital-Acquired Conditions Updated Baseline Rates and Preliminary Results 2014–2017.
Rockville, MD: Agency for Healthcare Research and Quality; January 2019.
Hospital-acquired conditions (HACs) represent a significant source of preventable harm to patients. The Centers for Medicare and Medicaid Services financially penalizes hospitals with increased numbers of HACs through the Hospital-Acquired Condition Reduction Program. This policy of nonpayment has prompted hospitals to focus significant resources on preventing HACs. This AHRQ report found a reduction in HACs from 99 per 1000 acute care discharges to 86 per 1000 discharges between 2014 and 2017, representing a decrease in 910,000 HACs and savings of $7.7 billion. Declines in certain HACs such as adverse drug events and Clostridium difficile infections were noted to be more significant as compared to others. A past WebM&M commentary highlighted the clinical significance of HACs and described an incident involving a patient who developed a pressure ulcer while in the hospital.
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
Drug Enforcement Administration. April 28, 2018.
Removing unused medications from the home can help prevent accidental exposure to unneeded medications and limit their availability for misuse. This annual program provides patients with an opportunity to discard medications safely. The sponsors also provide education to highlight the importance of appropriate disposal of unused prescription drugs as a medication safety activity.
Weiss AJ, Freeman WJ, Heslin KC, Barrett ML. HCUP Statistical Brief #234. Rockville, MD: Agency for Healthcare Research and Quality; January 2018.
Adverse drug events (ADEs) are common and can result in patient harm. This report analyzes data from the Healthcare Cost and Utilization Project to compare characteristics of hospital inpatient stays involving an ADE from 2010 and 2014. Information revealed by the data include impacts on length of stay, average costs, and whether the ADE occurred in the hospital or prior to admission.
Journal Article > Government Resource
Characteristics of initial prescription episodes and likelihood of long-term opioid use—United States, 2006–2015.
Shah A, Hayes CJ, Martin BC. MMWR Morb Mortal Wkly Rep. 2017;66:265-269.
Opioid use has become a growing patient safety concern. Recent studies have documented wide variation in opioid prescribing for acute pain and a significant rate of chronic opioid use after patients receive a first prescription for an acute indication. This retrospective medical record review study identified risk factors for remaining on an opioid medication for more than 1 year following their initial prescription. Older, female, and publicly or self-insured patients were more likely to remain on an opioid compared with younger, male, and privately insured patients. Patients started on higher doses (cumulative dose ≥ 700 mg morphine equivalent), provided prescriptions with longer duration (more than 10 days), or given 3 or more prescriptions for opioids were most likely to continue to use opioid medications 1 year later. The authors recommend prescribing fewer than 7 days of opioids for acute pain and adhering to the Centers for Disease Control and Prevention guideline for opioid use to improve prescribing practices.
Grissinger M. PA-PSRS Patient Saf Advis. December 2016;13:137-148.
Drawing from reports of medication errors submitted over a 7-year period to the Pennsylvania Patient Safety Authority, this analysis found that common problems included drug incompatibility and drug–drug interaction. The article cautions against relying on drug ordering alerts as the sole strategy for preventing potentially harmful prescribing.
Electronically Generated Medication Administration and Electronic Medication Administration Records for the Prevention of Medication Transcription Errors: Review of Clinical Effectiveness and Safety.
Ottawa, ON: Canadian Agency for Drugs and Technologies in Health; 2016.
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.
Rider BB, Gaunt MJ, Grissinger M. PA-PSRS Patient Saf Advis. September 2016;13:81-91.
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; September 20, 2016.
Highlighting how aging affects medication absorption that may lead to complications, this fact sheet offers recommendations for older patients to follow instructions, maintain a medication list, be aware of drug interaction potential, and perform an annual review of medications with clinicians to help them take prescriptions safely.
Rizk S, Oguntebi G, Graber ML, Johnston D. Research Triangle Park, NC: RTI International; 2016.
Standard term selection tools—like pick lists or drop-down menus—in information technology can create opportunities for user error due to human factors. This publication explores how mistakes such as selecting the wrong drug from an ordering pick list can occur in the ambulatory environment. The report includes recommendations and resources to help enhance medication safety when using these tools.
Journal Article > Government Resource
García MC, Dodek AB, Kowalski T, et al. MMWR Morb Mortal Wkly Rep. 2016;65:1125-1131.
Adverse drug events related to opioid medications are a significant patient safety concern. This analysis of insurer claims data demonstrated that changing opioid prescribing requirements, including implementing patient–provider agreements, requiring prior authorization, and enforcing quantity limits, led to a decline in opioid prescribing. The authors recommend that insurers implement policies from the Centers for Disease Control and Prevention opioid guidelines to improve safety.
Web Resource > Government Resource
Centers for Disease Control and Prevention.
FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 4, 2016.
This announcement alerts prescribers to differences in two oral formulations of the same medication that can lead to dosing errors. The FDA suggests that clinicians specify dosage form, strength, and frequency on prescriptions for this drug to reduce the risk of patient harm and recommend that pharmacists follow up with prescribers if such information is missing.
Computerized Prescriber Order Entry Medication Safety (CPOEMS): Uncovering and Learning From Issues and Errors.
Brigham and Women's Hospital, Harvard Medical School, Partners HealthCare. Silver Spring, MD: US Food and Drug Administration; December 15, 2015.
Electronic prescribing, considered an opportunity to reduce medication errors, has been linked to problems unique to technology use. This white paper discusses the results of a multi-hospital effort to develop a process and tools to collect and analyze data related to search, display, and workflow issues associated with computerized provider order entry. The authors offer recommendations to enhance the safety of electronic prescribing, including standardizing drug names, minimizing the number of alerts, and designing better search functions.
Unexpected Death of a Patient During Treatment With Multiple Medications, Tomah VA Medical Center, Tomah, Wisconsin.
Washington, DC: VA Office of Inspector General. August 6, 2015. Report No. 15-02131-471.
Drug–drug interactions resulting in adverse drug events are common causes of preventable harm to patients. This investigation determined that mixed drug toxicity was the cause of a patient's death at a Veterans Affairs facility and factors that contributed to the incident included lack of teamwork, informed consent, emergency response efforts, and equipment access.
FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; July 30, 2015.
Look-alike and sound-alike drug names can contribute to confusion and result in medication errors. To raise awareness of potential wrong-patient errors due to similarity between two proprietary names, this announcement describes near misses with the drugs at the prescribing and dispensing stage and suggests clinicians use the generic names for the medications to reduce risk of patient harm.
FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam).
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; May 20, 2015.