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United States of America
- United States Federal Government
- United States of America
Search results for "Department of Health and Human Services (HHS)"
- Department of Health and Human Services (HHS)
- Medication Errors/Preventable Adverse Drug Events
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.
Journal Article > Review
Joseph A, Henriksen K, Malone E. Health Aff (Millwood). 2018;37:1884-1891.
The built environment influences the safety and effectiveness of care delivery. This narrative review examines how care facility design can reduce health care–associated infections, falls, and medication errors. The authors provide suggestions regarding a range of facility design strategies and discuss how accreditation, funding, and policy organizations can support design projects as improvement efforts.
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.
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.
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
Mandatory provider review and pain clinic laws reduce the amounts of opioids prescribed and overdose death rates.
Dowell D, Zhang K, Noonan RK, Hockenberry JM. Health Aff (Millwood). 2016;35:1876-1883.
Opioid-related harm, including overdose deaths, has reached epidemic proportions. This study used a difference-in-differences analysis to examine whether a policy approach could reduce harm from opioid misuse. Investigators compared states with and without mandated provider review of drug monitoring data. In states with mandated review, opioid prescribers must check whether patients are receiving opioids from multiple prescribers and identify the total prescribed opioid dose. States with mandated review policies had fewer opioid overdose deaths and lower amounts of opioids prescribed than states without mandated prescriber review. These results are consistent with a prior study that established the benefit of prescription drug monitoring programs. The authors assert that despite the effectiveness of this policy, more interventions are needed to enhance opioid safety, as suggested in a recent study. A previous WebM&M commentary described opioid-related harm.
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.
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.
Journal Article > Study
Geller AI, Shehab N, Weidle NJ, et al. N Engl J Med. 2015;373:1531-1540.
Dietary supplements can cause harm, especially in combination with prescribed medication, and their use is increasing. This report from an established surveillance system sampled emergency department visits related to dietary supplements. The results suggest that adverse events related to dietary supplements cause 23,000 emergency department visits per year in the United States. Ingestions by unsupervised children accounted for nearly a quarter of the visits. Other common events included palpitations, chest pain, or tachycardia related to weight loss or energy supplements. The authors note that there is no legal requirement for supplement manufacturers to identify potential adverse effects on the products themselves, and they encourage clinicians to educate patients about potential adverse reactions.
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.
Journal Article > Commentary
Harris Y, Hu DJ, Lee C, Mistry M, York A, Johnson TK. Jt Comm J Qual Patient Saf. 2015;41:351-360.
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.
Journal Article > Study
Meaningful Use stage 2 e-prescribing threshold and adverse drug events in the Medicare Part D population with diabetes.
Powers C, Gabriel MH, Encinosa W, Mostashari F, Bynum J. J Am Med Inform Assoc. 2015;22:1094-1098.
This analysis of Medicare data found that outpatient practices using electronic prescribing had fewer adverse drug events among their panel of patients with diabetes compared to practices not consistently using electronic prescribing. Although promising, this study does not address the many differences between practices that use electronic prescribing versus those that do not and the patients that select these disparate health care systems.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 25, 2015.
The practice of using multi-dose insulin pens, meant for single patient use only, among multiple patients has been linked to health care–associated infections. This announcement outlines federal labeling requirements to raise awareness of the risks associated with this practice to prevent misuse of the devices.
Tavernise S. New York Times. January 15, 2015.
This newspaper article discusses an investigation into how a saline solution that had been manufactured specifically for training purposes was inadvertently distributed and used for actual care and led to patient harm and death.