Cases & Commentaries

Double Dosing, by the Rules

Commentary By Hedy Cohen, RN, BSN, MS

The Case

A 65-year-old woman with rheumatoid arthritis and
chronic obstructive pulmonary disease (COPD) was admitted to a
medical unit during the night with worsening shortness of breath.
Orders were written at 2:00 AM for prednisone 60 mg daily and for
continued administration of her daily methadone dose of 80 mg. The
medications were administered by the night-shift nurse when they
arrived on the unit at 6:00 AM, in accordance with a new policy
that specified that all newly ordered medications be administered
to patients within 4 hours.

The nurse assigned to this patient for the day
shift also administered the two medications at 9:00 AM to comply
with another policy regulating daily medication administration.
When the day-shift nurse documented his administration of the two
medications, he realized that the same medications had been
administered 3 hours earlier. He immediately notified the
physician, and continuous pulse oximetry and hourly vital sign
checks were conducted to watch for oversedation from the methadone
overdose. Fortunately, the patient was able to tolerate the extra
doses of prednisone and methadone with no lasting effects.

This incident illustrates how
multiple reasonable system policies can produce an unreasonable
result. The policy mandating that all new medications be given
within 4 hours of being ordered had just been implemented a few
days before the incident, while the policy of administering all
daily medications between 8:00 and 10:00 AM had been rigorously
enforced for many years. Both were policies designed to enhance
effectiveness and safety but, applied together, introduced a threat
to patient safety.

The Commentary

Over the past decade, the patient safety
movement has actively worked to shift the focus from practitioner
blame to analyzing how system failures allow errors to reach
patients. However, some health care organizations still fail to
recognize that, within each system, multiple interlinked key
elements can affect patient outcomes. When this linking is
recognized, a robust error analysis addressing all the elements can
help formulate improvements in the system as a whole. In this case,
two different system policies were instituted to improve medication
administration safety, and their overlap led to the error.

After analyzing serious errors, organizations
try to "fix" the cause of the error by concentrating their safety
strategies only on unachievable changes in the system (i.e., the
"low-hanging fruit," such as a nurse failing to follow the 5 Rights). But a more robust analysis of a medication
error allows reviewers to identify all the system failures that
allowed an error to occur. For example, in this case, both the
night and day nurses followed the 5 Rights when they administered
the right medication, dose, and route to the right patient at the
right time as dictated by organizational policy for drug
administration. A more thorough review of the error reveals that
the new policy was actually at the root cause of the error. (See
Addendum for an error analysis worksheet.)

Systems
Thinking

The hallmark of root cause analyses is systems
thinking. Senge defined a system as "a perceived whole whose
elements 'hang together' because they continually affect each other
over time and operate toward a common purpose."(1) Systems thinking entails seeing wholes rather than
parts. It provides a framework for seeing the changing patterns and
structures that underlie complex situations. To help simplify the
complexity of the medication-use system, the Institute for Safe
Medication Practices (ISMP) identified 10 key elements (Table) that organizations should consider when
developing system strategies to reduce or eliminate medication
errors.(2)
Both latent and active failures must be addressed thoroughly in
analyses of errors.

Latent
Failures

Latent failures are weaknesses in the structure
of an organization and often include one or more of the key
elements within the system. The weaknesses are the result of both
well- and ill-conceived decisions made by upper
management—even the best decisions carry risks and benefits,
and most involve a certain degree of compromise and trade-offs. The
immediate success or failure of a strategic change can be easily
identified once the change has been operationalized; however, the
far-reaching effects of these decisions often go undetected until
an error occurs. This is especially apparent when the strategic
decision prescribes a solution that shifts the problem from one
part of a system to another. Too often the individuals who "solved"
the original problem are different from those who ultimately
inherit the new problem. Organizations often develop error
prevention strategies following a serious event that focus solely
on specific risks without analyzing the unintended effects of those
strategies. For example, a new policy that required nurses to
immediately administer a new IV medication upon noting the order
might appear to be the correct strategy in response to the late
administration of a newly ordered IV vasopressin medication that
resulted in patient harm. However, the root cause of the error was
actually a communication failure, because the physician failed to
specify that it was a "stat" order. Without thorough analysis of
the error, this new strategy affected the administration of all
newly ordered IV medications. The new policy then has the potential
to increase the risk for other adverse events since pharmacy does
not have the time to check the medication orders prior to
administration. All too often the safety committee acts without the
benefit of insightful input from the practitioners involved as to
the cause of the error. Taken one at a time, the strategic changes
are often subtle, and their effect may go unnoticed, causing no
other problems. Sometimes their consequences are hidden, becoming
apparent only when they occur in sequence with each other (as they
did in this case) and combine with the active failure of
individuals to penetrate or bypass the system's safety nets.
Examples of such latent failures include the following: (i) lack of
adequate drug information—no medication reconciliation
process on admission and no "early dose" warning from the automated
dispensing cabinet; (ii) inadequate communication about potentially
conflicting medication administration policies and between health
care practitioners; and (iii) a push for efficiency over safety
that decreases the time for cognitive processing and double
checks.

Active
Failures

Active failures are errors
committed by individuals, usually practitioners who are in direct
contact with vulnerabilities and weaknesses within the structure of
the organization, such as occurred in this case. The error occurs
when individuals fall victim to the flaws within the system and
mistakes are made. Unfortunately, we often focus our attention on
these points of human fallibility. Active failures in this case
included: (i) not viewing or checking the patient's
complete medication history before prescribing,
dispensing, and administering; (ii) failure to communicate
medications administered and patient outcomes during shift handoff;
and (iii) failure to educate the patient about the medications
being administered. Although it may seem easier to concentrate on
the human contributions to errors, the root causes of the problems
often lie within latent failures and vulnerabilities. Therefore,
the only effective way to decrease the likelihood of error is to
strengthen the medication-use system's resistance to combinations
of latent and active failures.

Safety Strategies
Recommendations

To decrease the
probability of future errors involving the medication-use system,
this organization (and others like it) should consider the
following safety strategies:

Drug
Information:

  • Institute a robust medication
    reconciliation process that includes a column that asks when the
    last dose was taken/administered.
  • Ask the automated dispensing
    cabinet vendor if the "early dose" warning can be enhanced or if
    they can add a "hard stop." This is a requirement that the nurse
    has checked and documented why an early dose is being withdrawn
    from the automated dispensing cabinet before the drug can be
    released. It can be accomplished through a drop-down list or by
    using free text
    .
  • Conduct a nursing education
    program that stresses the importance of bringing the MAR to the
    bedside and monitor for adherence
    .

Communication
Dynamics:

  • Before adopting any medication-use
    policy, the organization should consider both the risks and
    benefits of the policy. They should also consider conducting a
    failure mode and effect analysis to determine
    the potential for failure and potential risk of harm.
  • Standardize patient-centric handoff
    communication, and mandate that it occurs at the time of nursing
    shift change, breaks in care, and changes in level of care.

Environment
Dynamics:

  • If the organization functions in a
    hierarchical model of patient care, move toward a culture that is
    collaborative and supports questions pertaining to drug
    therapy.
  • Create an environment that provides the
    time practitioners need to think through their patients' diagnoses
    and treatments and match the appropriateness of drug therapy with
    the patient (i.e., right drug for diagnosis, laboratory values and
    vital signs support the administration of the medication, etc.)
    rather than viewing drug distribution and administration as a
    task.

Staff
Education:

  • Share the lessons from errors like this
    one, so nurses are alerted to the hazards of the specific
    circumstances (administering early doses and repeating them later)
    and, more generally, to the hazards of conflicting policies.

Patient
Education:

  • Encourage patients to question their
    drug therapy when they are uncertain.
  • Educate patients about all aspects of
    their drug therapy, including the drug name (generic and trade),
    dose, times of administration, and reason they are receiving the
    medication, prior to administration.

Finally, Dr. James Bagian, a
safety expert and former astronaut, teaches his students that there
are two ways to die on a space mission: (i) not following
the rules and procedures as written; and (ii) following
the rules and procedures as written (J. Gosbee, MD, MS, written
communication, November 2008). Therefore, any new organizational
policy must go through a rigorous process, which includes a
multidisciplinary team, to ensure that the benefit to patient
safety is not compromised by the risk of an unintentional
outcome
.

Take-Home
Points

It is important to remember that
the design of any new policy:

  • Should not be a band-aid for a system
    flaw.
  • Must include input from end-users.
  • Must be examined for risk and
    pilot-tested for workability.
  • Must be routinely monitored for
    compliance and propensity to generate workarounds.

Hedy Cohen, RN, BSN, MS
Vice President
Institute for Safe Medication Practices

References

1. Senge P. The Fifth Discipline: The Art and
Practice of the Learning Organization. New York, NY: Doubleday
Business; 1994. ISBN: 978-0385260954.

2. Cohen MR, ed. Medication Errors, 2nd ed.
Washington, DC: APhA Publications; 2007. ISBN: 978-1582120928.

3. ASSESS - ERR™ Medication System
Worksheet. Horsham, PA: Institute for Safe Medication Practices;
2006. [Available at]

Table

Table. Key Elements That Organizations Should
Consider When Developing System Strategies to Reduce or Eliminate
Medication Errors.(2)

Patient information

Drug information
Communication
Drug labeling, packaging, and nomenclature
Drug storage, stock, and standardization
Drug device acquisition, use, and
monitoring
Environment factors
Competence and staff education
Patient education
Quality processes and risk management


Addendum

Addendum (3).
ASSESS - ERR™ Medication System Worksheet © 2006 ISMP.
Reprinted with permission from the Institute for Safe Medication
Practices.

Click on thumbnail for larger view.