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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 7, 2020. 

Nonprescription drugs are commonly associated with medication errors. This draft guidance seeks to provide a structure for industry to reduce instances of drug name confusion in nonprescription formulas of prescription medications. It describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency. The timeline for submitting comments is early February 2021. 

Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 2020.

Look-alike and sound-alike names weaken the safety of medication use. This guidance provides a structure for industry to reduce instances of drug name similarities and describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency.

Washington, DC: United States Government Accountability Office; May 20, 2020. Publication GAO-20-576R.   

This US Government Accountability Office (GAO) report highlights the chronic shortfalls in nursing home infection control programs. The GAO analyzed survey data from the Centers for Medicare & Medicaid Services (CMS) and found 82% (13,299) of nursing homes surveyed were cited in one or more years between 2013-2017 and in each individual year, 40% of nursing homes had infection control and prevention deficiencies that continued through 2018 and 2019.  While the majority of the citations did not indicate harm to nursing home residents and were rarely associated with enforcement actions, the GAO intends to examine CMS oversight of infection and control in the near future.  In light of the COVID-19 pandemic, these findings are particularly concerning.

Medicare Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose: A Closer Look. HHS OIG Data Brief. Washington DC; Office of the Inspector General: May 4, 2020. Report number OEI-02-19-00130.

Misuse of prescription opiates in the US continues to be a patient safety concern.  This data brief summarizes characteristics of the Medicare Part D population that routinely use opiates. It provides insights into the prevalence of patients diagnosed with opioid use disorders and others at risk for abuse that receive prescriptions for opioids.  A recommendation shared to address the situation is to assure patients diagnosed with the disorder get the medication-assisted treatment they need.

Washington DC: Office of the Inspector General; April 3, 2020. Report no. OEI-06-20-00300.

Frontline perspectives provide organizations with knowledge to inform improvement. This report summarizes survey results exploring organizational strategies to address workforce and patient safety challenges stemming from the current COVID-19 pandemic response.
HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics. Washington DC: US Department of Health and Human Services. October 2019.
Deprescribing has the potential to result in patient harm. This publication reviews considerations for physicians to safely discontinue or taper long-term opiate therapy. Elements of the guidance discuss assessment of risk, individualized care plans, shared decision making, and patient support as components of safe practice.
Studdert DM, Spittal MJ, Zhang Y, et al. The New England journal of medicine. 2019;380:1247-1255.
Malpractice claims can shed light on patient safety hazards. This observational study examined how paid malpractice claims affected physicians' practice. Investigators found that a small proportion of physicians, about 10%, had one or more paid malpractice claims, consistent with prior studies. Approximately 2% of physicians accounted for nearly 40% of paid claims. Physicians with paid claims were more likely to leave clinical practice and more likely to move to smaller practice settings. The authors raise the concern that physicians who move to smaller practice settings may lack the institutional and peer support to remediate their clinical skills and behavior. A PSNet perspective explored the risk of recurring medicolegal events among providers who have received multiple malpractice claims.
Adams JM, Giroir BP. JAMA internal medicine. 2019;179:476-478.
Physicians are in a unique position to address conditions that contribute to the opioid epidemic. This commentary highlights studies that examine the public health nature of the crisis. The authors call for physicians to educate communities, model empathy, and bring stakeholders together to address the community facilitators of opioid misuse.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; November 2018. Report No. OEI-06-14-00530.
Frail populations cared for in long-term care facilities are at high risk for adverse events. This report from the Office of the Inspector General (OIG) analyzed Medicare data from 2008 to 2016 to determine the prevalence of adverse events in long-term care facilities and the resultant harm to residents. Nearly half of patients experienced adverse events or temporary harm events. A significant proportion of these events were considered serious, meaning that they led to prolonged stay, transfer to acute care, provision of life-saving intervention, or resulted in permanent harm or death. More than half of these events were found to be preventable and were attributed either to error or substandard care. The OIG recommends that patient safety efforts undertaken by the Agency for Healthcare Research and Quality and the Centers for Medicare and Medicaid Services specifically address long-term care facilities. A past WebM&M commentary discussed safety and quality of long-term care.
Office of the National Coordinator for Health Information Technology; ONC.
Clinician burnout is a persistent threat to patient safety, and electronic health records have been identified as a high-profile contributor to the problem. This call for public comments on a draft report seeks insights on specific goals and recommended strategies to address the issue. The approaches outlined focus on reducing the time burden associated with frontline electronic health record use. The option for submitting comments is closed.
US Department of Health and Human Services; HHS; Office of the Inspector General; OIG.
Misuse of prescription opioids represents a serious patient safety issue. This data brief reviews federal Medicare statistics on opioid use by older Americans to highlight patient behaviors and provider prescribing patterns that could indicate, contribute to, or perpetuate unsafe opioid use.
Jewett C.
The Centers for Medicare and Medicaid Services decision to withhold payment for certain hospital-acquired conditions has prompted widespread efforts to prevent such events. This news article reports on an evaluation by the Office of Inspector General that found regulator review of hospital-acquired infection reports submitted to Medicare to be insufficient, which hinders hospitals' ability to learn from factors that contribute to infections.
Rizk S; Oguntebi G; Graber ML; Johnston D.
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.
Office of the National Coordinator for Health Information Technology; ONC; Health and Human Services; HHS.
Requirements are needed to manage risks associated with health information technology systems. This final rule provides a framework for government review of technologies certified by the ONC Health IT Certification Program. The rule also covers certification guidance for testing laboratories. The regulations were put into effect December 19, 2016.
Office of Disease Prevention and Health Promotion, US Department of Health and Human Services. Fed Register. 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.
National Quality Forum; NQF.
The Improving Diagnosis in Health Care report provided recommendations to help achieve safe, reliable diagnosis. This website provides the information about a project that has convened an expert panel to identify and develop new measures to help address weaknesses in testing and tracking diagnostic accuracy. .
Levinson DR; Department of Health and Human Services, Office of Inspector General; HHS; OIG.
The Office of the Inspector General (OIG) has issued a series of reports analyzing the incidence and preventability of adverse events among Medicare beneficiaries receiving care in acute care hospitals and skilled nursing facilities. This report used similar methodology based on trigger tools to determine adverse event incidence among patients in rehabilitation hospitals—post-acute care facilities that provide intensive rehabilitation to patients recovering from hospitalization for an acute illness or injury. The study found that 29% of patients experienced an adverse event during their stay, a proportion nearly identical to rates at acute care hospitals and skilled nursing facilities. Nearly half of the events were considered preventable, with the most common types of events including pressure ulcers, delirium, and medication errors. Nearly one-fourth of patients who had an adverse event required transfer to an acute care hospital for diagnosis or management, leading to a large increase in costs of care. Based on these data, the OIG has recommended that the Agency for Healthcare Research and Quality and Centers for Medicare and Medicaid Services disseminate information about patient harms in the rehabilitation setting and work to improve safety at rehabilitation hospitals. A previous WebM&M commentary discussed an adverse event at a rehabilitation facility.
Geller AI, Shehab N, Weidle NJ, et al. The New England journal of medicine. 2015;373:1531-40.
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.