SOURCE: Patient Safety Movement Foundation

Patient Safety Movement Foundation

May 14, 2014 10:37 ET

Centers for Medicare & Medicaid Services Updates Guidance to Better Protect Patients Receiving IV Opioids

IRVINE, CA--(Marketwired - May 14, 2014) - The Centers for Medicare & Medicaid Services (CMS) issued updated guidance for hospital medication administration -- effective immediately -- to reduce preventable deaths or serious adverse events related to intravenous (IV) opioid medications and blood transfusions.1 The CMS guidance "strongly encouraged" hospitals to review best practices from safety organizations including the Patient Safety Movement Foundation to help guide their implementations.

CMS's clarifications are provided for various provisions of 42 CFR 482.23(c), concerning medication administration, and 42 CFR 482.51(b)(4), concerning post-operative patient care.

An estimated one-third of all hospital adverse events are related to Adverse Drug Events (ADEs), affect approximately two million hospital stays annually, and prolong hospital length of stay by approximately 1.7 to 4.6 days.2 Each year, serious adverse events, including fatalities, associated with the use of IV opioid medications occur in hospitals, CMS noted in its memorandum. It also noted hospital patients on IV opioids may be placed in units where they typically are not monitored as frequently as in post-anesthesia recovery or intensive care units, increasing the risk that patients may develop respiratory distress that will not be immediately recognized and treated.

Hospitals should consider a number of recommended best practices related to use of IV opioid medications, including sedation assessment, frequency of monitoring and use of technology-supported monitoring, such as continuous pulse oximetry and ventilation monitoring linked to clinical staff notification devices, and referenced the Patient Safety Movement's Actionable Patient Safety Solutions (APSS):

CMS noted that the "Patient Safety Movement Foundation (PSMF) recommends all patients receiving IV opioids have continuous measure-through motion and low perfusion pulse oximetry, and that patients on supplemental oxygen also have continuous respiration rate monitoring. It also calls for the monitoring system to be linked with a notification system to clinical staff who can respond immediately. It calls for an escalation protocol so that if a staff person does not acknowledge the alert in 60 seconds a second person will be notified."

CMS also noted safety measures from the Institute for Safe Medication Practices (ISMP) and the Anesthesia Patient Safety Foundation (APSF).

ISMP makes available a list of high alert medications, which it defines as those medications that bear a heightened risk of causing significant patient harm when they are used in error. The current list may be found at:

Meanwhile, CMS stated that, "the APSF calls for every patient receiving postoperative opioid analgesics to be managed based on the following clinical considerations:

  • Individualize the dose and infusion rate of opioid while considering the unique aspects of each patient's history and physical status. 
  • Make continuous monitoring of oxygenation (pulse oximetry) the routine rather than the exception. 
  • Assess the need for supplemental oxygen, especially if pulse oximetry or intermittent nurse assessment are the only methods of identifying progressive hypoventilation.
  • When supplemental oxygen is indicated, monitoring of ventilation may warrant the use of technology designed to assess breathing or estimate arterial carbon dioxide concentrations. Continuous monitoring is most important for the highest risk patients, but depending on clinical judgment, should be applied to other patients." 

The APSF video on opioid-induced ventilatory impairment can be seen at

While opioid use is safe for most patients, opioid analgesics are associated with adverse effects3,4,5 and cause respiratory depression in 0.5% of post-surgical patients, who often receive them for pain management.6,7,8 Opioid analgesics rank among the drugs most frequently associated with adverse drug events, according to The Joint Commission.9 Of opioid-related adverse drug events -- including deaths -- that occurred in hospitals and were reported to The Joint Commission's Sentinel Event database (2004-2011), 47% were wrong dosing medication errors, 29% were related to improper monitoring of the patient, and 11% were related to other factors including excessive dosing, medication interactions, and adverse drug reactions.

"With this recent report, CMS brings greater awareness to the performance gaps that exist in our healthcare system, and the steps providers can take to improve patient safety," said Jim Bialick, President of the Patient Safety Movement Foundation. "We look forward to helping our partners in healthcare implement solutions, such as our APSS to achieve the ultimate goal of zero preventable patient deaths by 2020."

For more information about the Patient Safety Movement Foundation and its mission to eliminate preventable patient deaths by 2020, please visit

1 Center for Medicare & Medicaid Services. Survey & Certification Letter 14-15-Hospital.
2 Draft National Action Plan for Adverse Drug Event (ADE) Prevention (2013). U.S. Department of Health and Human Services.
3 Vila H Jr, Smith RA, Augustyniak MJ: The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: Is patient safety compromised by treatment based solely on numerical pain ratings? Anesthesia and Analgesia, 2005;101:474-80
4 Emergency department visits involving nonmedical use of selected prescription drugs - United States, 2004-2008. Morbidity and Mortality Weekly Report 2010, 59:705-709
5 Office of Applied Studies, Substance Abuse and Mental Health Services Administration. Substance abuse treatment admissions involving abuse of pain relievers: 1998 and 2008, (accessed October 28, 2011)
6 McPherson ML: Strategies for the management of opioid-induced adverse effects. Advanced Studies in Pharmacy, 2008;5(2):52-57
7 Jarzyna D, et al: American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Management Nursing, 2011;12(3):118-145.e10
8 Pasero C, M McCaffery: Pain assessment and pharmacologic management. Chapter 12 - Key Concepts in Analgesic Therapy, and Chapter 19 - Management of opioid-induced adverse effects. St. Louis, Mosby Elseveir, 2011
9 Joint Commission Issues New Sentinel Event Alert: Safe Use of Opioids in Hospitals, Aug. 8, 2012;

About The Patient Safety Movement Foundation
More than 200,000 people die every year in U.S. hospitals in ways that could have been prevented. The Patient Safety Movement Foundation was established through the support of the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare, to reduce that number of preventable deaths to 0 by 2020 (0x2020). Improving patient safety will require a collaborative effort from all stakeholders, including patients, healthcare providers, medical technology companies, government, employers, and private payors. The Patient Safety Movement Foundation works with all stakeholders to address the problems and solutions of patient safety. The Foundation also convenes Patient Safety, Science and Technology summits. The first annual Summit was held in January 2013 and brought together some of our nation's best minds for thought-provoking discussions and new ideas to challenge the status quo. By presenting specific, high-impact recipes to meet patient safety challenges, encouraging medical technology companies to share the data for whom their products are purchased, and asking hospitals to make commitments to implement Actionable Patient Safety Solutions, the Foundation is working toward zero preventable deaths by 2020. Visit

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