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Hospital Pharmacy 54(4)

Table 1. Fairview Opioid Adverse Event Classification.
Harm category

Description

Example

F

An event contributed to or resulted in
temporary harm to the patients and
prolonged hospitalization

G

An event contributed to or resulted in
permanent patient harm
An event which required intervention
to sustain life

Increase in hospitalization from prolonged treatment with
naloxone to reverse the effects of an opioid or sedative
Transfer to an ICU after naloxone administration for observation
and monitoring
Permanent injury or disability resulting from prolonged
respiratory depression caused by an opioid or sedative
Unexpected respiratory depression requiring ventilation
assistance and naloxone reversal in locations including nonICU patient areas, MRI, Emergency Room, endoscopy, cardiac
diagnostic services, and interventional radiology
Severe respiratory depression requiring assistance for naloxone
reversal and airway management from an emergency medical
response team (ie, Code Blue, Rapid Response)
Intubation and ventilator support temporarily needed for airway
management due to prolonged opioid or sedative effects
Death resulting from prolonged respiratory depression caused
by an opioid or sedative

H

I

An event which contributed to the
patient's death

Note. ICU = intensive care unit; MRI = magnetic resonance imaging.

depression. If an adverse event occurred, the level of patient
harm is rated using a revised National Coordinating Council
for Medication Error Reporting and Prevention (NCC MERP)
classification index for naloxone reversal and recorded in an
electronic database.10 All events due to an error that results in
significant harm or death (ie, NCC MERP classification F
through I) are reported to Fairview system leadership (refer to
Table 1).
Internal data on adverse events and patient harm is a fundamental driver for change in the patient safety culture
within Fairview. This evidence-based approach covers the
continuum of care including the emergency department, procedure areas, and hospital admission through discharge. The
adverse event data is reported at quality and safety meetings
to engage Fairview system leadership.

Form a Powerful Guiding Coalition With
Interdisciplinary Engagement
Creating a sense of urgency helps bring the right people
together to collaborate on a strategy for prevention of
adverse events related to opioids. It is important to assemble a group with enough influence to lead the change effort.
The group should include senior administration as well as
department leaders from provider services, nursing, pharmacy and infrastructure support such as information
technology.
In Fairview, the director of medication safety coordinates
the goals for mitigation of opioid adverse events. Executive
leaders at each hospital site align the opioid safety goals with
practice compliance through engagement of pharmacy, nursing, and physician champions. Prior to implementation of the
opioid stewardship model, activities such as assessment of
patient risk factors for respiratory depression or adjustment

of the opioid dose were conducted based on the discretion of
the individual practitioner. The concept of opioid stewardship provided an opportunity to establish a process for medication monitoring by coordinating multiple institutional
policies into a pharmacist scope of practice. The scope of
practice policy became the foundation for opioid stewardship by pharmacists.

Creating the Vision for Pharmacist Opioid
Stewardship
In successful transformation change efforts, the guiding
coalition must develop a map of the future and clarify the
direction in which the organization needs to move. The initial strategy may be developed by an individual leader and
then eventually refined by cross-functional teams into a
vision that can be achieved. Successful changes start with a
simple vision. However, opioid stewardship is not a simple
vision when taking into account all the locations where activities may occur.
The genesis for opioid stewardship in Fairview began
with implementation of a series of pharmacy practice policies to establish a consistent approach to monitoring opioid
prescribing and dispensing.11 Proactive monitoring of opioid
orders by pharmacists included ensuring the following12:
** Compliance with a policy that prohibits any dosing
range greater than 2-fold;
** Utilization of standardize patient-controlled analgesia
orders, including default starting doses, hourly limits,
and lockout intervals;
** Verification of opioid tolerance before approving
orders for intravenous basal rates (ie, continuous
infusion);
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