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When medication regulations collide with common sense


The original five rights of medication administration are a time-honored lesson all nurses learn—the right patient, right medication, right dose, right time, and right route. But have all of these rights stood the test of time?

Conventional wisdom doesn’t argue with the right patient, medication, dose, or route. But today, we may well question what is the right window of time that allows accurate, safe administration of a patient’s medications in a hospital or other care facility. Deep within the Interpretive Guidelines for Hospitals, a 370-page appendix to the online Medicare State Operations Manual (Centers for Medicare and Medicaid [CMS] Publication 100-07) is section 482.23(c)(1). Addressing drug preparation and administration, this section asks, “Are drugs administered within 30 minutes of the scheduled time for administration?” This “30-minute rule” has been on the books and in nursing policy manuals for many years. Last May, several respondents to a question on a nursing discussion website about “medication pass times” didn’t seem to know about this requirement, citing institutional practices that used a 1-hour window before or after the stated administration time.

Last summer, the Institute for Safe Medication Practices (ISMP), a nonprofit organization dedicated to medication-error prevention and safe medications practices, amplified its growing concerns about unintended consequences of the 30-minute rule. It astutely observed that rising nurse workloads and introduction of barcode medication administration technologies are creating a human-technology interaction that can cause risky compensatory behaviors—namely, shortcuts and workarounds. When ISMP surveyed nurses’ opinions and experiences in trying to meet the 30-minute rule, it received an overwhelming response from more than 17,500 nurses. Without question, nurses said they believed complying with the requirement can cause more harm than good.

Evolution of medication administration

When medication administration was exclusively manual, nurses simply verified a medication as given or noted the actual time the patient received it, with rare entries indicating a justified delay. Typically, medication-error audits excluded being outside the time window described in policy; instead, they focused on the more critical elements of the wrong patient, wrong medication, wrong dose, and wrong route.

With the advent of automated dispensing cabinets, electronic charting, and barcode medication administration, electronic time stamps are recording administration times—whether or not these times accurately reflect actual administration time or manipulated entries. The data then become available both internally and for external review.

Nurses are fully capable of making common-sense clinical decisions about administering medications. In most cases, they know when administration is time-sensitive and when, in contrast, they can use discretion in altering the administration time to accommodate patient activities and rest (as well as the nurse’s workload). By common sense, I don’t mean to imply these are simplistic decisions, because critical thinking and judgment about the patient’s condition guide the nurse’s decisions. But there are also simple decisions, such as giving the patient time to finish activities (bathing, toileting, and therapy, for instance) or adjusting for an unexpected event with a patient assigned to the nurse.

Risky behaviors

Nurses report that when they try to comply with the 30-minute rule and avoid a citation for noncompliance with regulations, they take shortcuts, such as removing medications in advance of administration times, removing them for multiple patients at the same time, charting in advance of the prescribed time, and asking nurses on the previous shift to pull medications for the current shift. Other workarounds include overriding automatic medication cabinet access to circumvent a pharmacist’s safety review, borrowing one patient’s medication for another, giving a medication without assessing the patient or reviewing current status, skipping double-checks, and skipping barcode scanning to avoid the time stamp that would indicate late administration. Nurses’ honesty in reporting these at-risk behaviors isn’t astounding; it simply reflects the dilemmas they face every day. No nurse would willingly put a patient in harm’s way, but these practices indeed create risk for error and patient harm.

Changing practice environments

While we’ve been searching for ways to make medication administration as safe as possible, well-intentioned nurses have been struggling with the 30-minute rule and probably didn’t realize they need to step back and evaluate the impact of new medication administration technologies. Such human factors as interaction with machines and computers, time availability, urgency, learning needs, fatigue, and stress can affect safety-related behavior.

Inevitably, unintended consequences occur with any new technology. For example, early experiences with barcode medication administration exposed the challenges of these complex systems, which led to changes in the scanners, workflow design, and staff training. Studying human factors and the reactions of people to workflow changes and technology can lead to more successful system design, development, deployment, and usability.

Influencing regulatory changes

Kudos to ISMP for raising this issue, soliciting input from the nursing workforce, and taking action with CMS to effect change that will improve patient safety. Its draft guidelines for timely drug administration are circulating with the help of nursing organizations; they appear on the website of the Agency for Healthcare Research and Quality (AHRQ) Patient Safety Network. (For the full text, visit

The ISMP guidelines offer greater flexibility in the timing of medication administration for non-time-critical medications. They suggest 2 hours for medications scheduled for daily, weekly, or monthly intervals and 1 hour for those scheduled more frequently than daily but no more often than every 4 hours. They propose additional guidance on more frequent dosing and suggest hospitals develop house-wide and unit-specific requirements for time-critical scheduled medications as well as first doses and loading doses. It’s not too late to add your comments on this important issue. You can send feedback to until February 15, 2011.

This is truly about control of nursing practice. Let’s lend our voices to help ISMP advocate for changes that are meaningful to patients and nurses.

Pamela F. Cipriano, PhD, RN, FAAN, NEA-BC
American Nurse Today


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    May 26, 2011 7:13 pm

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  • I concur with the sentiments reflected in the article. Although the intent is to increase patient safety, regulations have convened to make medication administration potentially less safe. This is a great example of how “listening” to the individuals who actually have to live with the scheduling issues and “hearing” their message would prove prudent for regulators. It may very well be time to reconsider the issues related to scheduling medications. Let good sense rule!

  • This is definitely a problem and the issues addressed are not new. Unfortunately hospitals have bought software that schedules meds for certain times for all patients receiving them. Patients often request to take their meds according to their home schedule. I have to document why each med was given at a different time that is very time consuming. Who’s need has the priority? Complying with the patient’s request or the pharmacy’s scheduling system and risk being written up for giving meds late?

  • Excellent food for thought.

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