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August 2014, Volume 18, Number 4
Article
Development of a Policy and Procedure for Accidental
Chemotherapy Overdose
Wendelin K. Nelson, PharmD, BCOP, Joan Moore, MSN,
APRN, AOCN®, ACNS-BC, Judith A. Grasso, RN, MSN, AOCN®,
Lisa Barbarotta, MSN, AOCNS®, APRN-BC, and
David S. Fischer, MD, FACP
A policy regarding rapid response to chemotherapy
overdoses was developed by the authors in an attempt to minimize morbidity and
mortality. The parameters of a chemotherapy overdose were defined to promote
early recognition of an overdose incident. Resources needed to guide potential
therapeutic interventions and required monitoring were
developed. The policy defines the immediate actions to be taken in the event of
a chemotherapy overdose. The availability of a chemotherapy overdose policy
provides an enhanced level of safety for patients by ensuring that appropriate
treatment is initiated without delay. The development of the policy was in
response to the reporting of a tragic error at another institution. Healthcare
providers must recognize and address potential areas of vulnerability to
maximize patient safety.
Chemotherapy protocols are complex and often
administered in busy environments under temporal constraints. Enormous effort
has been devoted to prevent chemotherapy error with attention focused on
computer physician order entry, improved infusion pump technology, advanced IV workflow
systems, specialty credentialing, and multiple double checks (Fischer, Alfano, Knobf, Donovan, &
Beaulieu, 1996; Goodin et al., 2011; Institute of
Medicine, 2000). Despite these preventive measures, erroneous chemotherapy
administration can still occur, with potentially tragic consequences in the
case of an overdose. The publication of a root cause analysis of a fatal
fluorouracil overdose in Canada (Institute for Safe Medical Practices [ISMP],
2007) identified multiple causative factors; chief among them was the lack of a
coordinated, rapid response to the overdose resulting from the absence of a
defined treatment protocol for accidental chemotherapy overdose. According to the report, “Staff members were uncertain as to how
best to treat and support the patient after the overdose was detected” (p. 6).
This published root cause analysis prompted the Yale-New Haven Hospital
chemotherapy safety committee, comprised of oncologists, oncology nurses, and
oncology pharmacists, to reassess the processes to ensure a robust response to
any chemotherapy overdose. This article describes the policy and procedure
developed by the authors to ensure rapid response to accidental administration
of an overdose of a chemotherapeutic drug (Moore, Grasso, Barbarotta,
Nelson, & Fischer, 2009).
Definition of Chemotherapy Overdose
Fundamental to establishing a response protocol to
chemotherapy overdose was to define chemotherapy overdose. A universal
definition of overdose is complicated by the large number and diverse therapeutic
indices of chemotherapeutic agents used in oncology and by a paucity of
clinical literature on this topic. In addition, the
route of administration, pharmacokinetics, and toxicity profile of the
overdosed chemotherapeutic drug also would influence the specific response that
medical personnel should make. Key clinical parameters of the patient also
would affect the outcome, including performance status, age, and comorbid
conditions. That multifactorial complexity led the authors to establish a conservative,
broad definition of potential overdose that encompasses relatively minor
variances as well as egregious overdose events. Because of a lack of
literature, the criteria to define a chemotherapy variance with potential for
overdose was determined by the authors with approval from the medical director
of the oncology program (see Figure 1). Even minor
chemotherapy variances may indicate a need for improved processes.
Identification and correction of these irregularities and their causes should
decrease the chance of serious variance or overdose. The authors’ primary
objectives in the codification of chemotherapy overdose policy were to increase
the vigilance of error identification and to provide guidelines for appropriate
responses to overdose events. The policy and procedure divides the process of
response to an identified variance in chemotherapeutic drug administration into
eight components: notification and information access, patient assessment,
treatment plan and intervention, monitoring and reassessment, documentation,
patient and family education, staff education, and variance analysis.
Notification
and Information Access
Activating a defined notification algorithm is a
critical element of a rapid response to a chemotherapy variance (Institute of
Medicine, 2000). The error may be discovered by any member of the oncology
treatment team, the patient, or the patient’s family or significant other. The
patient may be in the hospital, outpatient setting, or at home when an error
is discovered. Notification of the patient and family is the
responsibility of the attending oncologist. Of utmost importance is that the
patient be evaluated as soon as possible by the attending oncologist. A
patient’s nurse may be the one to discover the error, but this may not be true
in every case. If the patient is in the hospital, the nurse caring for the
patient must be immediately notified at the time the error is discovered. For
patients at home, initial actions should be directed by the oncologist via
phone communication. The authors’ communication algorithm was designed to
immediately notify experienced personnel, escalating the decision making toward
the attending physician with additional help from the medical director of the
oncology program and knowledgeable oncology nursing and pharmacy staff. This
team of senior staff adds objectivity, expertise, and accountability to the
patient assessment process (Katzenbach & Smith,
1994) (see Figure 2). The core group,
comprised of the attending oncologist, clinical nurse specialist, and oncology
pharmacy specialist, will promptly assess the patient, review the institutional
chemotherapy overdose protocol, obtain literature, and contact appropriate
consultation services to determine the best course of action. If not an
inpatient, admission to the hospital is at the discretion of the attending
oncologist and the medical director of the oncology program. If the variance
involves an investigational new drug or a clinical trial, the institutional
principal investigator and institutional review board must be promptly
notified. Accountability is ensured through the immediate notification of the
medical director of the oncology program, the director of nursing, and
notification of the legal and risk services departments.
To rapidly access pertinent
information related to chemotherapy variance, the policy and procedure provides
instructions about how to quickly navigate the relevant online resources to
find drug-specific toxicology and emergency management information. The
authors’ institution uses online versions of MicroMedex®
and Poisindex®, which are available at all
hospital clinical workstations and through employee home access. The policy and
procedures also provide contact information for the state poison control
center.
Patient
Assessment
Prompt patient assessment by the attending physician
or his or her clinical representative (nurse practitioner or physician
assistant) is a critical early step. A main premise is that most, if not all
side effects will be increased in a significant chemotherapy variance or
overdose situation. A broad baseline of laboratory and metabolic values
documenting bone marrow, renal, and hepatic function should be established. Key
diagnostic actions include
·
Physical examination and vital signs, paying
particular attention to signs and symptoms of infection and drug toxicity
·
Complete blood count with differential;
comprehensive metabolic panel including electrolytes, calcium, magnesium and
phosphate; blood urea nitrogen; serum creatinine;
liver function tests; and coagulation parameters (prothrombin
time, partial thromboplastin time)
·
If the patient is symptomatic, obtain a chest
x-ray; blood, urine and sputum cultures; and administer broad spectrum
antibiotics per institutional guidelines.
Medical personnel should contact appropriate
consultation services. The exception is a mandatory, immediate consultation
with neurology and neurosurgery in the event of an intrathecal
overdose (see Figure 3).
Treatment
Plan and Intervention
Time is a critical factor in a potential overdose
situation. Prompt response can have a significant impact on patient outcome (Goldfrank, 2006). In addition to notifying all
personnel listed on the notification algorithm, the oncology treatment team may
contact the state poison control center to obtain additional information.
Initial general interventions should include establishing IV access and
beginning hydration and forced diuresis, if not contraindicated. After
consulting current pharmacology and toxicology references, the oncology team
should create a list of possible side effects and initiate specific prophylaxis
measures based on involved systems (see Table 1). At
this time, appropriate consultation services should be contacted. The oncology
pharmacist should review the complete list of medications the patient is
taking, as drug interactions may affect the pharmacokinetics of the
chemotherapy drug.
No known antidotes or reversal agents exist for many
chemotherapy agents (Goldfrank, 2006; Goodin et al., 2011). As part of this policy,
the authors compiled a table of therapeutic agents reported in the medical
literature as possible interventions in the event of a
chemotherapy overdose (see Table 2). The
amount of supporting clinical data for overdose of the agents varied because of
limited evidence and reliance on case reports. Attending oncologists should
review the primary literature and make assessments based on the strength of
evidence. If indicated, they should obtain and administer an intervention agent
to minimize toxicity.
The potential for error increases with the rising
number of oral chemotherapy agents prescribed and administered outside the
supervision of a clinical setting. Elapsed time between ingestion and
intervention is always a factor in successful management of overdose situations
(Goldfrank, 2006), particularly for orally
administered chemotherapeutic agents. However, an error may not be discovered
immediately. Specific time-sensitive recommendations include the use of gastric
lavage with airway protection if performed within one hour of ingestion (Goldfrank, 2006). Consider using activated
charcoal with dose based on age.
Monitoring
and Reassessment
Periodic monitoring and reassessment are critical as
the status of the patient changes over time. Monitor all body systems as
required, depending on the major toxicities of the agent(s) involved. Compare
baseline laboratory values and review systems at regular intervals. Specifics
of timing and laboratory parameters monitored will depend on the toxicity
profile of the chemotherapy agent(s) involved and the route of administration.
In addition, monitor parameters linked to specific interventions. Check for
signs and symptoms of infection at regular intervals, assessing for expected
toxicities and revisiting the need for subspecialty consults. The attending
oncologist or clinical representative (nurse practitioner or physician
assistant) should call and assess at-home patients daily or as often as
clinically indicated.
Documentation
Clear and objective documentation is an essential
aspect of this process. Personnel directly involved in a chemotherapy variance
must complete an online medication event report. For a chemotherapy error,
multiple descriptions of the same event may be written from various vantage
points and submitted. Elements of the protocol that must be logged include the
notification algorithm, specifically recording who was called and when. The
patient assessment, clinical workup, and treatment plan, including a discussion
of current and anticipated side effects, all need to be detailed. Also,
personnel should detail information on the monitoring level, reassessment plan,
and time frame. Discharge instructions are provided to the patient and
documented in the electronic medical record. These include patient expectations
and requirements necessary to comply with the increased scrutiny of the
treatment and monitoring plan.
Patient
and Family Education
The patient will likely have challenging questions
that are best addressed by an experienced practitioner. For this reason, the
attending oncologist needs to lead patient and family education discussions. A key
aspect of this process will be emotional support for the patient and family.
Provide an opportunity to discuss the event and express related feelings.
Strongly consider involving a social worker to facilitate a supportive
discussion. The presence of a patient representative or advocate may be
helpful.
Specific information provided to the patient should
include the anticipated side effects, what is known about the incident, and
what the patient can expect. This may be particularly difficult if little is
known about the overdose of a particular agent. Medical personnel should
clearly detail the specifics and rationale of the treatment and monitoring
plan, and what will be required of the patient and family. In addition to
speaking to the patient, personnel should provide the patient with written
physician contact information, including 24-hour emergency (answering service)
telephone numbers along with instructions to return to the clinic or emergency
room should any problems occur. The patient must be directed to go to the
nearest hospital in an emergency and bring with them their discharge
instructions and physician contact information. The closest hospital may not
necessarily be the institution where chemotherapy was administered.
Staff
Education
Once this policy and procedure was approved by
hospital management, the authors’ institution initiated education for oncology
physicians, nurses, and pharmacists, with departmental and on-unit reviews. An
online education program was developed with a post-test. Testing assessed
ability to recognize potential overdose situations and to take appropriate
actions. The education was reinforced for nurses by including the protocol in
the hospital’s annual chemotherapy recertification course. The information also
was communicated via poster presentation at the institution’s annual safety and
quality conference.
Variance
Analysis
An essential part of handling a serious chemotherapy
variance is an objective analysis of the process failures that led to the
error. The institution should initiate a multidisciplinary review of procedures
governing chemotherapy order writing, production, and administration.
Identification of points of failure and implementation of corrective actions
are the primary outcome of the variance analysis. The institution needs to
provide staff debriefing and emotional support to staff involved in the
incident. Staff directly involved in a chemotherapy variance will likely feel a
wide range of emotions, any of which may have unintended ramifications on the
process of analysis of the error (Osborne, Blais,
& Hayes, 1999). Responsible staff may experience a level of
denial or lack of knowledge concerning the potential seriousness of
consequences associated with the variance. In addition, individuals may feel
shame or embarrassment at not catching a serious error and fear of reprisal
from the employer or litigation. Emotional assessment and professional support
issues need to be addressed in a timely manner.
Implications for Practice
Chemotherapy overdose is a multidisciplinary event
with shared accountability across oncology medicine, nursing, and pharmacy.
Multidisciplinary teamwork enables the most efficient response to hopefully
minimize morbidity and mortality. Although precisely quantifying the effect of
this policy is difficult, a heightened awareness and vigilance has been
achieved through staff education regarding early recognition and response for a
potential chemotherapy overdose.
Nurses play a vital role in chemotherapy order
verification, administration, and patient and family education. By defining
criteria for early recognition of a potential overdose, nurses are empowered
with the knowledge to rapidly respond, using an established policy for
assessment and monitoring. Possible interventions are identified and nurses are
provided with a guideline for appropriate patient and family education.
Conclusion
Recognizing and addressing areas of vulnerability in
the complex process of chemotherapy delivery is critical to maximizing safety.
Despite a robust set of safety precautions already in place, errors still can
occur. Much has been published on essential safety systems that focus on error
prevention; however, implementing a rational plan in the event of a potential
overdose situation also is needed to optimize the safety net provided to
patients receiving chemotherapy drugs. A clearly defined, rapid response for
chemotherapy variance delineates assessment responsibility and provides general
information on monitoring and potential treatment options that must be
initiated without delay to decrease patient morbidity and mortality. This plan
educates and guides staff about immediate actions to take if the systems do not
prevent error.
Implications for Practice
Ø
Establish practice guidelines that facilitate
early recognition and immediate actions following a potential chemotherapy
overdose.
Ø
Identify potential therapeutic interventions
and system-specific assessments to promote patient safety.
Ø
Educate patients and family members regarding
the treatment plan and required monitoring to achieve the optimal outcome after
a chemotherapy overdose.
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Wendelin K. Nelson, PharmD,
BCOP, is a clinical specialist in oncology in the Department of Pharmacy at Smilow Cancer Hospital at Yale-New Haven and Joan Moore,
MSN, APRN, AOCN®,
ACNS-BC, is an education specialist at Yale-New Haven Hospital, both in New
Haven, CT; Judith A. Grasso, RN, MSN, AOCN®, is a self-employed oncology nurse consultant in
Middletown, CT; Lisa Barbarotta, MSN, AOCNS®, APRN-BC, is a
hematology/oncology advanced practice nurse at Smilow
Cancer Hospital at Yale-New Haven; and David S. Fischer, MD, FACP, is a
clinical professor of medicine in the School of Medicine at Yale Cancer Center
in New Haven. The authors take full responsibility for the content of the
article. The authors did not receive honoraria for this work. The content of
this article has been reviewed by independent peer reviewers to ensure that it
is balanced, objective, and free from commercial bias. No financial relationships
relevant to the content of this article have been disclosed by the authors,
planners, independent peer reviewers, or editorial staff. Moore can be reached
at joan.moore@ynhh.org, with copy to
editor at CJONEditor@ons.org. (Submitted September 2013. Revision submitted November 2013.
Accepted for publication December 1, 2013.)
Key words: chemotherapy; overdose; policy
http://dx.doi.org/10.1188/14.CJON.18-04AP