Oncology Pharmacotherapy
IDENTIFYING SOURCES AND REDUCING THE POTENTIAL FOR CHEMOTHERAPY-RELATED
ERRORS: MISSION IMPOSSIBLE?
Thomas W. Ross, MS, RPh, and Jodi R. Wojdylo, PharmD
Department of Pharmacy, H. Lee Moffitt Cancer Center & Research Institute
Questions relating to drug use, dosing, and related issues in oncology
are presented in this regular feature.
Introduction
Published events in recent years have focused the attention of the medical world and,
perhaps more significantly, that of the general public on the occurrence and impact of
medication errors. Reports concerning medication errors, such as the widely publicized
"Dana-Farber Incident" (Boston Globe, June 26, 1995; 29,33) have promoted
a policy of "zero tolerance" for medication errors in the eyes of the public.
The medical world, on the other hand, is faced with perpetual changes in the health care
environment, making the provision of error-free care quite challenging.
The changes include, but are not limited to, the incorporation of managed care into the
health care system. There is a trend toward increased competition, and thus emphasis is
placed on cost containment. As a means of limiting costs, many institutions have reduced
the number of supportive staff -- those who traditionally served as safeguards and
double-checks in the medication administration system. The health care workers who remain
must care for more patients, thereby promoting a more hurried environment. Along with this
change, a shift toward reimbursement based on capitation rather than the traditional
fee-for-service method has resulted in attempts to decrease lengths of stay for inpatients
and a tendency toward treatment in the ambulatory setting. This is evidenced by the fact
that in 1996, approximately 75% of all dosages of chemotherapy were administered in
physicians’ offices, in clinics, and via home infusion.1 Although this
practice has been common at numerous institutions for many years, optimal safeguards
implemented in the inpatient setting may be missing or abbreviated in the ambulatory
setting.
Other changes in the health care environment involve those related to the
antineoplastic agents themselves. The challenge of preventing errors and the magnitude of
those that do occur are even more pronounced in the oncology field. Four factors
contribute to this phenomenon:
(1) The narrow therapeutic window of cytotoxic agents creates the potential for serious
adverse sequelae, even in the event of a "minimal" error.
(2) As research demonstrates the benefits of combination chemotherapy and dose
intensification, the regimens being used have become more complex. Furthermore, these
regimens often require concomitant ancillary medications for prophylaxis against adverse
events related to chemotherapy.
(3) The acceptance of newer high-dose therapies, particularly those with stem-cell
rescue, has promoted a level of comfort among health care providers when prescribing
extreme dosages.
(4) Health care providers may not be fully familiar with the various agents available,
especially given the proliferation of new drugs and unique therapeutic categories on the
market in the past few years.
While the prevention of all chemotherapy errors may seem like an unattainable goal,
health care professionals must continuously strive to achieve this end for many reasons.
First and foremost is the basic ethical responsibility of health care providers to do no
harm. Second, medication errors may be financially costly to an institution, whether due
to litigation stemming from an error or due to iatrogenic effects requiring further
treatment or prolonged hospitalization. Classen and colleagues2 reported that
adverse drug events, which include medication errors, can be attributed to increasing the
length of stay by an average of 1.74 days and have an associated average cost of $2,262.
This cost becomes even more significant as various authors have reported that between 42%
to 67% of serious adverse drug events3 or iatrogenic injuries4 are
preventable.
Another reason to strive toward error-free medical care involves the devastating impact
of an error on the public’s perception of the implicated health care provider and/or
institution. As shown by the extraordinary attention surrounding recent errors, the media
will capitalize on these unfortunate events. Additionally, disclosure of an error or a
complaint filed by a patient may result in an investigation by the Joint Commission on
Accreditation of Healthcare Organizations or another regulatory agency; ultimately,
licenses and certifications may be revoked. Finally, there may be legal implications for
individual health care providers responsible for errors; this fact is reinforced by the
recent indictment of three nurses for their involvement in a fatal medication error.5
This is the paradox of today’s health care environment. There is a lower tolerance
for errors and workers are functioning in an environment with ever-increasing demands.
Alone, an individual’s effort to be conscientious may reduce the risk of medication
errors. However, as Michael R. Cohen, president of the Institute for Safe Medication
Practices, stated in analyzing a chemotherapy-related error, "One thing this incident
should teach us, once and for all, is that we simply cannot rely on people alone to
prevent medical accidents."6 Therefore, a systems approach to reducing
errors should be adopted.
Definitions and Concepts
Numerous editorials, reports, and research concerning medication errors, adverse drug
reactions, adverse drug events, and other problems associated with drug therapy have been
published. Medication errors, as defined by the American Society of Health-Systems
Pharmacists,7 include errors in prescribing, dispensing, and administering
medications, as well as errors in patient compliance. This definition does not include
therapeutic failures, intentional overdoses, adverse drug reactions and allergic
responses, or errors that were prevented by the system (ie, never reached the patient).
The major concept on which this article is based is that of a systems-oriented
approach, which has been advocated by many as the optimal approach to reducing and
preventing errors. Sylvia Bartel, director of Pharmacy at the Dana-Farber Cancer
Institute, recently emphasized this by stating, "The systems approach is a good one
because we’ve found out . . . just how complex errors are."8 By
adhering to the tenets of continuous quality improvement, a systems-oriented approach can
effectively address the issue of medication errors within a health care facility; the
focus is placed on the system, not on individuals. Using objective data, root problems in
the system can be identified. This information can then be used to improve the system and
decrease the potential for error. Key ideologies of a systems-oriented approach include
the following9,10:
(1) This approach seeks to be proactive in preventing problems and optimizing outcomes.
(2) The entire process, not just one or two steps within the process, must be
understood and continually improved in order to achieve the best possible outcomes. Errors
most commonly arise due to many simultaneous failures within a system.
(3) Emphasis is placed on the system, not the individuals within the system. This is
often referred to as the "85/15 Rule," which states that at least 85% of the
problems can be corrected by changing the system, while less than 15% are under an
individual’s control.
(4) Within a given system, approximately 80% of the trouble arises from only 20% of the
problems. Commonly called the "Vital Few" or the "80/20 Rule," this
concept suggests that major gains can be achieved by concentrating efforts on a few key
problems.
(5) An interdisciplinary team approach is the most effective means of addressing
complex problems.
(6) The improvement process should use a scientific approach and hard data rather than
rely on subjective opinions in making decisions.
In applying a systems-oriented approach to the issue of medication errors, a frequent
question that may arise is, "What is an acceptable error rate?" Despite efforts
to establish a national benchmark, none has been developed, according to the Institute for
Safe Medication Practices (personal communication, August 1997). The lack of a universal
benchmark is due to the widely variable definitions of what constitutes a medication error
as well as the gross underreporting of medication errors. While a benchmark or
"acceptable" level of errors has not been established, the goal of any
medication error program should be the prevention of all errors.
Sources of Medication Errors and Recommendations for Minimizing Them
The prevention of medication errors in cancer chemotherapy is a complex and challenging
goal. To meet this challenge, health care facilities must develop a systems-oriented
approach to treating patients with antineoplastic agents. Interdisciplinary involvement
ensures that multiple health care providers serve as double-checks within the system.
Attending physicians, fellows, medical residents, physicians’ assistants,
pharmacists, and nurses should all be intimately involved in the care of
hematology/oncology patients, and patients themselves should take active roles in their
care. Chemotherapy errors may occur at various instances within the overall treatment
course, beginning with the initial evaluation of the patient and extending throughout the
ordering, preparation, administration, and monitoring of these agents.
Initial Evaluation
Upon initial patient evaluation, the practitioner is responsible for obtaining a
thorough and accurate medical history, for ordering diagnostic procedures and laboratory
parameters, and for assessing the disease state to develop an optimal treatment plan. The
initial evaluation is the foundation for therapy. The patient should be an active and
educated participant in making these treatment decisions. Once chemotherapy is chosen, the
physician must critically evaluate available treatment options based on extrapolation of
the literature to the given patient. To avoid potential toxicities, the patient’s
diagnosis and extent of disease must be confirmed and organ function must be appraised
prior to determining which chemotherapy regimens are appropriate. Depending on the drug or
regimen selected, specific attention should be paid not only to renal, hepatic, cardiac,
pulmonary, and neurologic function, but also to previous treatments such as radiation
therapy.
Once a regimen is selected, clear documentation of intended therapy should be placed in
the patient record to facilitate verification by other members of the health care team.
Common regimens are available in standard reference texts, and all protocols approved by
the Institutional Review Board should be readily available. If the physician selects a
regimen that deviates from either of these, a photocopy of supportive literature should be
placed in the patient’s medical record. When an "ad hoc" regimen is chosen,
the rationale should be clearly documented in the medical record by the prescribing
physician. That way, all members of the health care team will be informed. If a subsequent
problem ensues, the purpose for selecting of nonstandard therapy can be identified.
Ordering
The health care practitioner must be meticulous in prescribing chemotherapy to prevent
deleterious consequences. The first step in the prescribing process is choosing
antineoplastic therapy to which the tumor is responsive. Depending on specific patient
parameters, dosing may then be based on established regimens or may be individualized. An
often overlooked but important consideration in calculating dosage is specifying the
dosing weight of the patient (ideal, actual, or adjusted). Institutions are encouraged to
develop standards in calculating dosages and to require that the desired dosing weight be
clearly indicated in the chemotherapy orders. Chemotherapy orders must be written in the
medical chart or entered into a computer system in a precise fashion. Ideally, the initial
order writing should be performed by the oncology physician. This is consistent with the
various health care providers’ scopes of practice and ensures the opportunity for
thorough double-checking by nurses and pharmacists.4 Initial chemotherapy
orders should never be given verbally. In instances where verbal orders are permitted (eg,
emergency situations or the modification of existing orders), the verbal order should be
dictated directly from the physician to the practitioner transcribing the verbal order. If
possible, a second health care provider should witness this communication and co-sign the
written transcription of the order. This order should then be carefully reiterated to the
physician for confirmation and signed by the physician as soon as possible. A summary of
common errors in the ordering of chemotherapy and recommendations to prevent them is
presented in the Table, and an example of a chemotherapy order form is shown in the
Figure.
Education of all health care workers is vital in reducing the potential for error.
Chemotherapy should be prescribed only by those who are credentialed by the institution to
do so. The institution may wish to define specific exceptions to this standard for the
prescribing of chemotherapy agents for non-oncologic indications (eg, low-dose
methotrexate for the treatment of rheumatoid arthritis or bleomycin for pleurodesis).
Oncology fellows should complete an institution-specific chemotherapy training and
certification program and have their orders co-signed by a credentialed physician during a
defined initial training period.4 Given the diverse nature of training programs
and their various levels of experience, the writing of chemotherapy orders by medical
residents should be strongly discouraged.4 No matter how knowledgeable health
care providers are regarding chemotherapy in general, they must be familiar with the
policies and procedures of chemotherapy ordering within an institution since adherence ot
these policies and procedures offers a standard by which prescribers can practice. When
approved individuals order chemotherapy in a standardized manner, errors are less likely
to occur.
The educational needs and credentialing should not be limited to physicians. All other
health care professionals involved in the care of oncology patients should be required to
undergo chemotherapy training and certification specific to their aspect of care (eg,
nurses should be familiar with administering chemotherapy and monitoring for side
effects). Nurses may pursue national certification as an oncology certified nurse (OCN)
and/or as a certified pediatric on-cology nurse (CPON). The Board of Pharmaceutical
Specialists is currently developing a certification examination for oncology pharmacy that
is expected to be available in October 1998.
After initial certification, health care professionals should be required to attend
educational inservices at designated intervals to maintain chemotherapy privileges.
Documentation of certification and attendance of the aforementioned programs should be
filed within the institution for ready retrieval.
In addition to these continuous educational efforts, current oncology-specific
reference materials and copies of all active protocols should be readily available to all
health care providers.11 Oncology-specific texts that may prove useful include The
Cancer Chemotherapy Handbook by Fisher et al12 and Cancer Chemotherapy
Handbook by Dorr et al.13 Additional general pharmacy references such as Facts
and Comparisons14 and the American Society of Hospital Pharmacists’ Drug
Information15 should also be available.
Preparation and Dispensing
The pharmacists and pharmacy technicians involved in the preparation and dispensing of
chemotherapy must employ measures not only to serve as a double-check, but also to
properly and safely admix the drugs. On receipt of an order, whether written or
transmitted via computer, the pharmacist should evaluate the appropriateness of therapy
prior to compounding the agents. The care nurse should be contacted to ensure that line
access has been obtained and that the patient status has not changed. These precautions
may prevent the unnecessary preparation and eventual waste of chemotherapy.
A system should incorporate as many checks and balances as possible. Involving more
than one pharmacist in processing a chemotherapy order is ideal. Accurate entry into the
computer system for reproducible admixing is necessary. Labels should clearly indicate
generic drug name, dosage, route, frequency, and dates of administration in addition to
the individual patient’s name, unique identification number, and room number. The
expiration date of the preparation, the time it was prepared, and the dose number within
the sequence should be recorded. The fact that it is a cytotoxic agent should be
indicated, and instructions for storage and special administration should be provided.
When preparing the chemotherapy, the pharmacy staff should adhere to a systematic,
step-wise approach to ensure that the product is both accurate and aseptic and that those
preparing the medication are protected:
- Proper training and certification must be provided for those individuals, preferably
pharmacists or pharmacy technicians, who are responsible for chemotherapy preparation.
- To minimize contamination of either the product or the workers, established policies and
procedures should be followed to ensure the use of proper sterile technique within a
certified biological safety cabinet.
- To avoid confusion, vials should be reconstituted with an acceptable diluent to a
standard concentration.
- Calculations to determine the precise amount required must be done prior to withdrawing
the drug in order to deliver the ordered dose. Ideally, these calculations should then be
double-checked. Also, if the chemotherapy is to be further diluted, a compatible diluent
and reasonable volume must be determined before admixing. Errors may be decreased by using
specific guidelines to standardize this process.
- To facilitate administration and to decrease the potential for inadvertent chemotherapy
exposure, tubing should be inserted and primed with the base solution only.
- In withdrawing the drug, a negative pressure method should be used to avoid leakage of
the agent from the vial.
- A spill should be immediately contained. Specially trained staff should then follow
methods outlined by policies and procedures of the institution to clean the spill.
- The preparation should be wrapped and sealed in a plastic bag and labeled as
chemotherapy.
- Upon delivery to the floor, the preparation should be placed in a location reserved
specifically for chemotherapy, and the nurse should be notified. Important information to
convey, when appropriate, should indicate if the drug is sensitive to heat or light, if it
has a short expiration dating, and if it is part of a time-specific protocol.
- Although not recommended, the chemotherapy may be prepared by the nurses or physician
when specific situations arise. In these instances, proper facilities, training,
credentialing, and quality assurance measures should also be in place. The general
guidelines outlined in this section, as well as all applicable professional practice
standards, should be followed.
Administration
Those involved in administering chemotherapy -- typically nurses -- must be as cautious
as the physicians who prescribe the regimens and the pharmacists who process the orders.
The nurses responsible for chemotherapy administration should be certified in this area of
specialty practice. The following additional double-checks should be performed by the
nurse:
- Check that the drugs and doses are exactly those that were originally ordered and
supported by a protocol, handbook, or literature reprint.
- Verify that the preparation is, in fact, intended for the specific patient by comparing
it with the original order and the patient’s knowledge of the intended treatment
plan. The patient’s name, room number, and unique identification number indicated on
the label should match that on the patient’s armband.
- Validate the selection and timing of therapy.
- Recalculate all doses.
- Certify that all laboratory parameters have been obtained and are within guidelines to
proceed with administration.
- Ensure that the proper route of administration is available for use.
- Affirm that all premedications and necessary supportive care measures are readily
available. Just prior to administering the chemotherapy to the patient, the nurse should
corroborate this information with a second nurse, emphasizing the patient’s name, the
physician’s orders, and the labeling of the chemotherapy.
During the actual administration, the nurse also plays an important role in preventing
the occurrence of errors. The route of administration and technique used (eg, intravenous
bolus vs infusion) must be consistent with that ordered. Well-established literature
supporting safe methods of administration is available. For example, a vesicant agent
should be given only intravenously, and preferably by the push method via a central line.
Relatively well-established literature is also available on compatibility and stability
with concomitant agents being administered. Before using a single lumen line for numerous
preparations, an intravenous compatibility reference text should be consulted. If
compatibility is not ensured, drugs may precipitate in the line and result in obstruction,
or an agent might lose some of its potency. Useful texts include the King Guide to
Parenteral Admixtures16 and the Handbook on Injectable Drugs.17
Nurses should protect themselves from exposure to the chemotherapy and should ensure
protection of the patient. Following administration of the preparation, the empty
container should be discarded in a specific OSHA-approved chemotherapy waste bin.
Administration of the preparation, the patient’s vital signs, and any side effects
should be documented. Precautions should extend beyond administration of the agent to
include handling of potentially contaminated body fluids and waste.
The entire health care team should educate patients and their families (or caregivers)
so that they are participants in the therapy. Patients not only become more informed, but
also are more likely to feel a sense of empowerment in managing their disease. They can
also serve as the final check in the system.
Monitoring
All patients receiving chemotherapy should have an established baseline assessment (eg,
physical examination, laboratory parameters) to serve as a monitoring tool throughout
treatment. Follow-up assessment typically requires clinic visits between chemotherapy
sessions. During these appointments, health care professionals can obtain not only
objective data (eg, laboratory values and vital signs), but also subjective data (eg,
patient perspectives). Questionnaires or computer programs can help in obtaining and
tracking this information, and noted trends can assist in guiding future therapy. All
pertinent information should be documented and stored in some sort of longitudinal,
readily retrievable database so that data remain consistent and do not have to be
reproduced with each visit to the facility. This record also provides a means of reporting
allergies and adverse drug reactions. Finally, the patients themselves must be actively
involved in their monitoring. Patient education is important both during and following the
administration of chemotherapy. Patients should receive as much discharge counseling as
possible from all disciplines. They can learn to monitor their own vital signs, look for
indications of potential infection, and document medication administration and overall
well-being records. In doing so, they become participants in providing themselves with
optimal care.
In addition to monitoring individual patients, an institution should have in place an
ongoing process to document and assess those errors that do occur. This is important from
a risk management perspective. The systems-oriented approach to reducing and preventing
errors requires a data-driven method to be most effective. The first step in this process
is to encourage the reporting of medication errors so that continuous improvement measures
can be implemented. Reports of medication errors should not be used negatively in a
performance appraisal. The next step involves an interdisciplinary review of all errors.
The review should focus on the root causes that led to the error and the development of
system improvements to prevent future occurrences of such an error. Finally, the review of
errors should be an ongoing process; frequent retrospective reviews of archived data will
help to identify trends and emerging problems that may be overlooked in individual reviews
of errors. Without active reporting of medication errors, efforts to proactively prevent
future errors may be hindered.
Conclusions
- Communication is paramount in reducing chemotherapy-related errors, not only among the
various health care professionals, but also with patients. An open rapport must be
developed, and lines of communication must be established and used. Collaboration among
health care professionals is a necessity in today’s complex medical world.
- Specific steps that can be incorporated by the interdisciplinary team to reduce the
potential for chemotherapy errors include development and implementation of the following:
- Policies addressing the training and credentialing of health care workers
- Guidelines and algorithms for therapy selection
- Policies concerning chemotherapy order writing and processing
- Policies specific to the preparation, dispensing, administration and monitoring of
chemotherapy
- A system of double-checks prior to administration of the medication
- Information systems
- An institutional plan under the auspices of the Pharmacy and Therapeutic Committee (or
equivalent body) to monitor chemotherapy errors and make systems-based recommendations to
reduce their future occurrence
The public’s expectations concerning the provision
of error-free medical care may be unrealistic, given the number of confounding factors in
today’s oncology setting. The current environment makes the provision of
"perfect" health care even more difficult. Despite the extraordinary challenges
in providing error-free care, health care professionals must continually work toward
achieving this goal for the sake of the health care system itself and, more importantly,
for the sake of the patient.
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