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Search results for "Department of Health and Human Services (HHS)"
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Famolaro T, Yount ND, Hare R, et al. Rockville, MD: Agency for Healthcare Research and Quality; April 2019. AHRQ Publication No. 19-0033.
The Agency for Healthcare Research and Quality conducts safety culture surveys in a wide variety of clinical settings and makes the results publicly available on a regular basis. This report contains responses to the Community Pharmacy Survey on Patient Safety Culture from 331 participating pharmacies, most of which were chain drugstores or pharmacies within integrated health systems. The areas of strength were similar to the 2015 report, with most community pharmacies scoring well for patient counseling and openness of communication regarding unsafe situations. Inadequate staffing and production pressures were the commonly identified barriers to safety. A PSNet perspective explored safety issues in the community pharmacy setting in detail.
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.
FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2018.
Web Resource > Government Resource
Centers for Disease Control and Prevention.
Journal Article > Commentary
Dowell D, Haegerich TM, Chou R. MMWR Recomm Rep. 2016;65:1-49.
Opioid pain medications carry high risk for adverse drug events and misuse. Due to climbing rates of opioid use and associated adverse events, the Centers for Disease Control and Prevention released new guidelines for prescribing opioid medications for chronic pain. These guidelines do not apply to patients receiving cancer treatment, palliative care, or end-of-life care. The authors recommend using opioids for chronic pain only if nonopioid medications and nonpharmacologic approaches to chronic pain are not effective and prescribing immediate-release instead of long-acting medications. For acute pain, they recommend limiting duration of therapy, stating that more than 1 week of medications should rarely be needed. The guidelines also suggest minimizing concurrent use of opioids and other sedating medications and dispensing naloxone to prevent overdoses. A previous WebM&M commentary describes an adverse event related to opioids.
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.
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.
Famolaro T, Yount N, Sorra J, et al. Rockville, MD: Agency for Healthcare Research and Quality; June 2015. AHRQ Publication No. 15-0041-EF.
This survey expands AHRQ's patient safety culture work to the community pharmacy setting. Approximately 1600 pharmacy staff from 255 community pharmacies voluntarily completed the survey between 2013 and 2014. The database is meant to allow for comparison and benchmarking of safety cultures across pharmacies. However, the current response rate represents less than 1% of total community pharmacies in the United States, and more than half of respondents were chain drugstores or integrated health systems. Most community pharmacies scored well for patient counseling and communication openness, while staffing, work pressure, and pace represented the biggest areas for potential improvement. A prior AHRQ WebM&M interview with J. Bryan Sexton explored the relationship between culture and patient safety.
Journal Article > Review
U.S. compounding pharmacy-related outbreaks, 2001–2013: public health and patient safety lessons learned.
Shehab N, Brown MN, Kallen AJ, Perz JF. J Patient Saf. 2018;14:164-173.
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.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 2015. Report No. OEI-01-13-00400.
A widely-reported meningitis outbreak in the United States uncovered quality and safety issues associated with the use of compounded sterile preparations. This publication describes an analysis of five accreditation organizations and their ability to provide oversight and inspection of Medicare hospitals that contract with compounding entities. The authors offer recommendations to help hospitals determine if their compounded sterile preparations contracts ensure products are prepared safely for use, including targeted training for surveyors related to compounding and improved contracting processes.
Tools/Toolkit > Fact Sheet/FAQs
Rockville, MD: Agency for Healthcare Research and Quality; December 2014.
Tools/Toolkit > Fact Sheet/FAQs
Silver Spring, MD: United States Food and Drug Administration; October 31, 2014.
Studies have shown that pharmacist involvement can prevent medication errors. To help patients take their medications safely, this consumer update discusses pharmacists as participants in a government drug information center and reveals the top five questions submitted along with their corresponding answers.
Rockville, MD: Agency for Healthcare Research and Quality; August 2013. AHRQ Publication No. 13-0067-EF.
This report summarizes findings from projects that explored how health information technology can augment quality and safety in ambulatory care.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; December 6, 2012.
Tools/Toolkit > Government Resource
Rockville, MD: Agency for Healthcare Research and Quality; July 2018.
This survey and accompanying toolkit were developed to collect opinions of community pharmacy staff on the safety culture at their pharmacies. The data collection process for the latest national comparison is now closed.
Web Resource > Government Resource
US Food and Drug Administration.
This Web site raises awareness of risks associated with buying medications from online pharmacies and offers resources to help identify whether an online pharmacy is safe or fake.
Hospira Carpuject pre-filled cartridges—drug alert: products may contain more than the intended fill volume.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; May 23, 2012.
This announcement raises awareness of pre-filled medication cartridges that may be overfilled, thereby increasing the risk of overdose. The FDA recommends that practitioners confirm the dosage prior to dispensing and administering the medication.
Legislation/Regulation > Government Resource
Atlanta, GA: Centers for Disease Control and Prevention; May 2, 2012.
This statement describes the Centers for Disease Control and Prevention's guidelines on appropriate use of single-dose vials to prevent disease transmission.
Silver Spring, MD: US Food and Drug Administration; October 31, 2011.
This report outlines the complex nature of drug shortages and suggests strategies to augment the FDA's efforts to address them.