ead the Multifactorial Medication Mishap case study below
Complete the root cause analysis worksheet to analyze the case..
The Case
A previously healthy 50-year-old man was hospitalized while recovering from an uncomplicated
spine surgery. Although he remained in moderate pain, clinicians planned to transition him from
intravenous to oral opioids prior to discharge. The patient experienced nausea with pills but told
the bedside nurse he had taken liquid opioids in the past without difficulty.
The nurse informed the physician that the patient was having significant pain, and liquid opioids
had been effective in the past. When the physician searched for liquid oxycodone in the
computerized prescriber order entry (CPOE) system, multiple options appeared on the list—two
formulations for tablets and two for liquid (the standard 5 mg per 5 mL concentration and a more
concentrated 20 mg per mL formulation). At this hospital, the CPOE system listed each choice
twice, one entry with the generic name and one entry with a brand name. In all, the physician
saw eight different choices for oxycodone products. The physician chose the concentrated
oxycodone liquid product, and ordered a 5-mg dose.
All medication orders at the hospital had to be verified by a pharmacist. The pharmacist
reviewing this order recognized that the higher concentration was atypical for inpatients but
assumed it was chosen to limit the volume of fluid given to the patient. The pharmacist verified
the order and, to minimize the risk of error, added a comment to both the electronic medication
administration record (eMAR) and the patient-specific label that the volume to be given was 0.25
mL (5 mg). For added safety, the pharmacist personally retrieved, labeled, and delivered the
drug and a calibrated syringe to the bedside nurse to clarify that this was a high concentration
formulation for which the volume to administer was 0.25 mL (a smaller volume than would
typically be delivered).
Shortly thereafter, the nurse went to the bedside to administer the drug to the patient for his
ongoing pain. She gave the patient 2.5 mL (50 mg) of liquid oxycodone, a volume that she was
more used to giving, and then left for her break. A covering nurse checked on the patient and
found him unconscious—a code blue was called. The patient was given naloxone (an agent that
reverses the effect of opioids), and he responded well. He was transferred to the intensive care
unit for ongoing monitoring and a continuous infusion of naloxone to block the effect of the
oxycodone. By the following morning, the patient had returned to his baseline with no apparent
adverse effects.
The Commentary
Medication errors in the hospital are all too common. Although it may seem that the only error in
this case was the nurse giving the wrong amount of medication to the patient, many latent errors
contributed to harm reaching the patient. Medication errors are rarely caused by failure of a
single element or the fault of a single practitioner.(1) For example, in a root cause analysis (RCA)
of a fatal medication error in which a nurse administered the wrong medication by intravenous
route, an external review found four main proximate causes and multiple performance-shaping
factors that contributed to the event.(2) To prevent similar errors from occurring, the reviewers
identified more than 15 suggested changes that spanned the medication use system at the
hospital.(2) Because medication errors are often multifactorial, analysis of errors should always
identify weaknesses in the system and corrective plans should include risk reduction strategies
that span multiple processes.
Systems Approach to Medication Errors
The goal of a system-based analysis of errors is to discover underlying system failures that are
amenable to correction. In their landmark study using a systems analysis of adverse drug events,
Leape and colleagues identified several domains where underlying problems occurred. These
domains included lack of information about the patient, drug stocking and delivery problems, and
inadequate standardization.(3) Similarly, the Institute for Safe Medication Practices (ISMP) has
identified 10 key system elements that have the greatest influence on safe medication use (Table
1).(4) Although other categorizations also exist, this commentary will use ISMP’s model to
analyze the case. Readers who also wish to analyze errors in this manner can use a worksheet
available on ISMP’s Web site (http://www.ismp.org/tools/AssessERR.pdf).
Developing Effective Risk Reduction Strategies
Identifying errors in the system may indicate where changes need to be made. There are two
objectives of safe system design: (i) to make it difficult for individuals to make mistakes and (ii) to
permit the detection and correction of errors before harm occurs.(3) However, designing effective
strategies to make the system safer is difficult. It is easy to implement low leverage strategies
(“weak” interventions) as a quick fix for an error. For example, a simple response to this case
would be to tell the nurse to read the medication label and electronic medication administration
record (eMAR) more carefully, the pharmacist to give better instructions, and the physician to be
more careful when using the CPOE system. Such strategies are unlikely to prevent an error from occurring again as they rely on humans to avoid mistakes. Instead, higher leverage strategies
(“strong” interventions) that prevent human errors from propagating through the system should
be implemented.
In the rank order of error-reduction strategies (Table 2), high leverage strategies create lasting
change in the system. Fail-safes, constraints, and forcing functions are types of strategies that
improve the system with minimal reliance on human vigilance and memory. On the other hand,
providing education and information and drafting rules and policies are easy to implement but
often rely on human vigilance. These low leverage strategies are likely to only be effective if
combined with interventions that target systems issues.(5,6)
System-Based Analysis
A robust system-based analysis of this error might discover failures that are amenable to higher
leverage solutions to prevent future occurrence. Rigorous analysis of medications errors should
use the ISMP model and examine the 10 key system elements (Table 1). Applying the framework
in the analysis of this case reveals a substantial number of failures and areas for clear system
improvement.
Patient Information
Both the pharmacist and the physician in this case were likely unaware of key patient information which may have contributed to the error. For example, the physician may not have known the
patient’s opioid-use history, such as which liquid opioid he used in the past, and thus could not
reorder that specific medication and dose. It appears the pharmacist was not directly aware of
the patient’s opioid use in the past and assumed the patient was a candidate for concentrated
oxycodone. To prevent similar gaps in the future, the institution should ensure that information
about a patient’s diagnoses, allergies and adverse reactions to medications (including the
inability to tolerate specific formulations of medications), and patient-monitoring information is
readily available to all practitioners.
Drug Information
All three practitioners lacked pertinent drug information to make safe decisions. The physician
was unaware that liquid oxycodone comes in two concentrations, the pharmacist did not know
that the concentrated product was not appropriate for an opioid-naïve patient, and the nurse,
who was unfamiliar with the concentrated formulation, did not realize that the volume to be
administered was indeed much less than to what she was accustomed. Multiple steps can be
taken to prevent these knowledge gaps in the future. Up-to-date drug information should be
available to all practitioners, and practitioners should know how to use these references. Highalert medications, such as concentrated oxycodone, should have additional safeguards that
guide practitioners to their appropriate use. For example, a pain order set, guideline, or protocol
could be used to identify when a patient is ready for escalation to more potent pain medications.
Finally, restrict prescribing of certain medications, especially those that are used rarely, to
specialized practitioners who are familiar with their use (e.g., a pain specialist in this case).
Communication of Drug Information
Not only were there issues with knowledge about the drug, but the lack of clear communication
of drug information also contributed to the error. The list of choices that resulted when oxycodone
was searched in the CPOE system was confusing. Even though there were four distinct
oxycodone products, eight were listed due to duplication. Furthermore, the concentrated liquid
was not sufficiently distinct from the regular product on that list. Unfortunately, the pharmacist
and prescriber did not communicate on the intended plan for the patient to clear up the
confusion. In response, the institution should ensure that when new products are added to a
hospital’s formulary and built into the CPOE system and all aspects of the user interface should
be examined. If medications are restricted to certain patient populations, that restriction should
be reflected in the CPOE system. For example, if concentrated oxycodone is restricted to
ordering by pain specialists, this drug should not be available on the list of medications available
to general practitioners in the CPOE system. There should be clear lines of communication
between all practitioners. If a pharmacist or nurse has concerns about the appropriateness of a
medication order, he should feel comfortable and obligated to question the prescriber.
Drug Standardization, Storage, and Distribution
The manner in which the medications were stored and distributed contributed to the error in this
case as well. For distribution, the pharmacist dispensed the entire bottle of oxycodone, and the
nurse was required to measure out the patient-specific dose. Ideally, medications should be
dispensed from the pharmacy in the most ready-to-use form, which minimizes manipulation by
the nurse. Pharmacies should dispense liquid medications that come in bulk bottles in unit-dose
cups or oral syringes for those with standardized dosages or in oral syringes with the patientspecific dose already drawn into the syringe for the nurse.
Staff Competency and Education
Knowledge gaps in the safe use of opioids may have also contributed to this error. It is not clear
if the physician, pharmacist, and nurse had adequate training on the optimal use of opioids for
acute pain. According to an opioid knowledge assessment conducted by the Pennsylvania
Hospital Engagement Network Adverse Drug Event Collaboration, practitioners of all levels had a
weak understanding of important aspects of safe opioid use. The study suggests that
organizations educate and assess staff understanding regarding effects of opioids on sedation
and respiratory depression, differences between opioid-naïve and opioid-tolerant patients,
indications for long-acting opioids, equianalgesic dosing among opioids, and required monitoring.
(7)
Patient Education
Although it is not discussed directly in the case, the patient may not have been aware of the
medication he was taking. Furthermore, he may not have been able to request the same opioid
he tolerated in the past because he did not know the name. To help them prevent errors, patients
and families should be empowered to detect medication errors by encouraging them to ask
questions about their medications and the purpose of their medications and by explaining the
safeguards that are being used to ensure they are receiving the right medication and dose.
Quality Processes and Risk Management
Lastly, more robust quality control processes may reduce the likelihood of this type of error. For
example, the nurse did not have another practitioner independently double-check the medication
before administering it. Although they should not be the only safeguard and should be used
judiciously, independent double checks (the procedure in which two clinicians independently
check each component of prescribing, dispensing, and administering a medication) can detect up
to 95% of errors.(8) While the case does not detail the hospital’s processes surrounding
identifying, reporting, and analyzing medication errors, all organizations should actively cultivate
a culture in which error reporting is encouraged and non-punitive and leads to meaningful
change. Using errors and near misses to identify systems issues should be done in an
interdisciplinary manner. Proactive risk assessment tools, such as failure mode and effects
analysis (FMEA), will help institutions ensure that new medications, processes, and services are
implemented safely.
Conclusion
This case highlights the different system weaknesses that together resulted in an error harming
the patient. Although it would be easy to fault the individuals involved, the absence of prescribing
criteria for and restriction of concentrated oxycodone, the lack of a standard dispensing practice
that minimizes nursing manipulation, and the need for staff education and guidance on such
high-alert medications, among other factors, contributed to this event. To ensure all gaps in the
system are addressed, a rigorous analysis using a model, such as ISMP’s Key Elements of the
Medication-Use System that is used here, should be employed. Furthermore, when designing
changes, hospitals should adopt high leverage risk reduction strategies as much as possible. For
example, instead of telling the nurse to read the label more carefully next time, the manipulation
of the medication can be taken out of the nurse’s responsibility. Although the patient did not
experience any lasting adverse consequences in this case, adopting strategies that address
system weaknesses will decrease the risk that an error of this type will reach another patient.
Take-Home Points
Medication errors are multifactorial; they are rarely due to only one failure mode or individual.
When analyzing medication errors, employ a systems approach by identifying weaknesses
throughout the medication use system.
When choosing risk reduction strategies to implement, focus on those that do not rely on human
vigilance or memory.
Use proactive risk assessment tools whenever new medications, processes, and services are
implemented to prevent errors.