INTRODUCTION
Health care is often
not as harmless as it has to be. A considerable body of evidence connects preventable
medical errors as a chief cause of injury and mortality. These medical errors are the consequence of multiple inherent
errors in the healthcare delivery system. For example, shortage of readily
available dispensers for hand hygiene or sinks for hand washing near patient
rooms may cause insufficient hand hygiene of the doctors and hospital staff. In
addition, medication-associated errors are also one of the most common
varieties of error, affecting the large numbers of people and accounting for a
substantial raise in health care costs (Johnson,
Jeffrey and Bootman, 1995). Similarly, paediatric oncology departments are
known for their greater rate of medication errors. The medication errors
in oncology are mainly related to chemotherapy and these may occur in any type
of cancer treatment programs, with resultant severe effects like drug toxicity or
bad influence on disease control. Drug
administration is basically a multiprofessional course. The low therapeutic
index and high toxicity of chemotherapy medicines make such errors a
considerable issue, leading to unnecessary patient morbidity and expenditure
(Dhamija, Kapoor and Juneja, 2014). Gandhi et al (2005) noted a 3%
medication errors rate in a paediatric department where chemotherapy was
infused. On the other hand, it was found that 60% of those blunders had the probability
for unfavourable drug events. Good thing was that majority of these errors were
stopped from being happening before they affected the patient. A study by Walsh
et al (2009) also reported medication related error of about 18.8% in the paediatric
oncology. Medication ordering was the most frequent types of errors noted in
this study. Likewise, Taylor, Winter,
Geyer and Hawkins (2006) demonstrated an error rate of 9.9% in chemotherapy
medication administered orally in children with acute lymphoblastic leukaemia. Understanding
and restraining chemotherapy errors are very important. In order to check and
analysis such errors in health care, a number of methods have been implemented.
Healthcare Failure Mode and Effects Analysis (HFMEA) is one of those methods.
It is basically a qualitative methodology for identifying and amending such hidden
system errors in the health care setting ahead of time such errors may lead to unpleasant
outcomes.
The purpose of this
study is to assess the safety of chemotherapy administration in cancer patients as well as to analyze potential failure
modes in the pediatric oncology ward of a national medical
center. It also aims to decrease the likelihood of
failure in the administration process, chemotherapy order, and
chemotherapy-associated prescribing errors cut off by clinical pharmacists
before reaching the patient. HFMEA
makes it easy to carry out the recognition of actions intended at decreasing
medication errors in a healthcare setting, since the functioning of a number of
these have already led to a lessening in errors in the prescription process of drugs,
substantiation and dispensing.
METHODOLOGY
Setting
A retrospectively
review of records were carried out from visits to two paediatric oncology
departments in the (city, country) for medication related errors by means of
Healthcare Failure Mode and Effects Analysis (HFMEA). A multidisciplinary team
conducted this review and this team comprised of paediatric oncologists, nurses,
patient’s parents, pharmacists and a medical informatics. They mainly assembled
to check and evaluate chemotherapy order, monitoring process and administration
in all settings i.e. outpatient and inpatient in the paediatric patients. The
HFMEA team was led by the head of paediatric oncology department. The team was
also included of two nurses’ expert in providing paramedical task during
chemotherapy.
The team recognized
a variety of ways in which each constituent of the process may fall short.
Failure modes were described, and values were assigned for each failure mode,
to two attributes of each failure mode: probability and severity. A probability
index explains the probability of incidence of the failure mode and can take
one of the four values: value = 1(remote) specifies that it is dubious to
happen in the next five years; value = 2 (rare) shows it is likely to happen in
the next five years; value = 3 (sporadic) designates a likelihood of incidence
of once or twice a year and final value of 4 (frequent) shows that it is probable
to happen instantly or at a number of times a year (DeRosier, Stalhandske, Bagian, et
al., 2002). On the other hand, severity
index was given four values. The index value basically defines the failure
outcomes. The values assigned include: score = 1(negligible) signifies no harm
to the patient, call for high level of care or stay length; score = 2 (moderate)
signifies extended period of stay or high level of care for patients; score = 3
(major) demonstrates permanent diminishing of function of the body for a single
patient or extended period of stay or a need for high degree of care for 3 or
more than 3 patients; and score = 4 (disastrous) shows permanent loss of
function or motility for any patient (DeRosier, Stalhandske, Bagian, et
al., 2002).
The particular
topic of the HFMEA was decided by conversations with the paediatric oncology
Department and hospital management group. The administrative group of the
hospital then officially commissioned the HFMEA to be executed. A flow diagram
of the practice was developed and possible failure modes were recognized and accessed
via a hazard scoring matrix. For each
failure mode a hazard score was calculated by multiplying the probability and
severity indices producing values varying between one as a smallest value and
sixteen as a highest hazard score
(DeRosier, Stalhandske, Bagian, et al., 2002). Finally by the
help of the decision tree the failure mode requiring further actions were
determined. A decision tree was used based on a hazard score equal or above 8. Corrective
interventions for failure modes with the maximum hazard scores were made and
prioritized. Ethical consideration was not done here because the study mainly
involved identification and detection of ongoing safety program without
including patients in the study.
Procedure
During the process
of the HFMEA, necessary information was gathered by the team from records,
meetings, and interviews. The interviews were mainly conducted from doctors
responsible for infusion of chemotherapy in the children suffering from cancers
to shed light on areas of vagueness in interpreting the important chemotherapy
associated guidelines. Members of the paediatric oncology department also
attended a meeting for additional conversations with the HFMEA team. The record
material mainly comprises the tools for chemotherapy monitoring, administration
RESULTS
HFMEA analysis and flow Process
An overview of the order
of chemotherapy and administration process is shown in Fig.1. The whole process was grouped into seven main
steps and these were prescription, confirmation, entry of order, review of
order, transmission, administration of drugs and monitoring.
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Fig. 1: Flow diagram
of chemotherapy process
Hazard Analysis and Failure Modes
The hazard analysis found 15 potential failure modes with altering
degree of rate of incidences and intensity of outcomes. A sum of three failure
modes had the maximum likely hazard score of 11, demonstrating the collective possibility
for recurrent occurrences i.e. expected to take place instantly and temporary and
a disastrous result (demise or permanent function loss). Table 1 exhibits
the failure modes with the maximum hazard scores and subsequent recommendations
by the HFMEA team. A number of steps e.g. order review, prescription of
chemotherapy drugs, steps of monitoring and administration were linked to the
failure modes of the greatest mutual likelihood and severity.
Handwritten prescriptions and signed by unofficial prescribers, chemo administered
and reassessed by un-authorized nurses were linked to the possibility of producing
adverse outcomes. Therefore, team suggested implementing a number of guidelines
and recommendation for chemotherapy infusion in paediatric oncology with
necessary protections, as given below in table 1. These include review of a
process of prescription order by authorized nursing staff, tutoring nurses and
oncologists regarding the significance of improving safety of chemotherapy and enlightening
patients about unfavourable effects of chemotherapy medicines.
Procedure
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Failure
modes with hazard score = 11
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Recommendations
by team
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chemotherapy
prescribed
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handwritten
prescriptions orders
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Practise
computerized prescriber for chemotherapy orders entry with proper safeguards
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Prescriptions reassessed by un-authorized nurses
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Chemotherapy
drugs administered and noted
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Barcode
detection is avoided
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Instruct
nurses regarding the significance of barcode recognition to chemotherapy
safety
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Oral chemotherapy
order reviewed by nurse
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Prescription
written by unofficial prescriber
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Implement a procedure to give review to the
prescription by a chemotherapy-certified oncologists or nurses
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Mistakes
in frequency or dosing not noticed
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Guidelines
for chemotherapy medication is needed to be developed, comprising of
information for dosing, modifications, safety measures and contraindications
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Patient
monitored for unfavourable outcomes
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Patient
is not aware of or remember instructions
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Make pamphlets containing information for
patients
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Table 1: HFMEA identified Failure modes linked to the maximum hazard
scores and subsequent recommendations by team.
Discussion
The HFMEA methodology was used to address problems not amenable to
quantitative methods: the assessment of medication and system errors in the
process of administration of chemotherapy in paediatric population.
Chemotherapy drug safety practices and understanding is still suboptimal. While
a number of guidelines have deal with these issue and ensured safe administration
and handling of anticancerous agents (Jacobson, Polovich, McNiff, et
al., 2009; Griffin, 2003). Hardly any have recommend standards to decrease
chemotherapy prescribing mistakes. This can be explained by the fact that a
great number of hospitals did not have particular obligations for prescriptions
of chemotherapy (Weingart, Flug, Brouillard, et al., 2007).Quality-enhancement
programs are planned to accomplish the axiom ‘above all-do no harm’ (Smith,
2005). In this particular study and hospitals assessed, and in response to better
knowledge regarding the safety risks linked to chemotherapy, the chemotherapy
process was proactively evaluated with a particular attention on prescribing,
ordering and administration by means of HFMEA. HFMEA is a mean that attempts to
methodically evaluate. This evaluation may either be retrospectively or
prospectively and is a multifaceted process. It distinguishes those factors
which have the risk of causing damage and prioritizing corrective interventions.
The HFMEA is recommended to be used as a proactive risk evaluation tool.
Several studies have reported it successful utilisation of HFMEA in medicine as
well in enhancing chemotherapy safety (Bonnabry, Cingria, Ackermann, et
al., 2006; Van Tilburg, Leistikow, Rademaker, et al. 2006;
Bonfant, Belfanti, Paternoster, et al., 2010). However, it is important
to note that HFMEA must not be considered as the mere mean for quality enhancement
by healthcare institutions, because the knack to recognize and assess failure
modes in any practice considerably relies on the team evaluating the practice (Shebl, Franklin and
Barber, 2009).
Conclusion
HFMEA offered valuable analysis of the chemotherapy practice in the
paediatric oncology in three hospitals. And thus, interventions were put into
practice to lessen risk and enhance patient safety. The recommendations and
implementation from this HFMEA analysis are believed to offer an encouraging
outcome on a big number of other processes of medication. The findings of this
study are in accord with different other published HFMEA analysis taken place in
a paediatric oncology department where chemotherapy prescription and
administration were found to have greatest hazard scores (Robinson, Heigham, and
Clark, 2006).
HFMEA is now actively carried out in numerous healthcare processes and
in oncology it serves a great role since chemotherapy is considered to be a
high-risk course. Using HFMEA potential risk can easily be identified and
corrective measures can be taken to curtail those risk. In addition, computerized physician order
entry (CPOE) is successful in
decreasing prescribing errors of antineoplastic agents and should be regarded
as a component of a fail-safe practice to enhance safety.
There are some limitations in this study, including the failure to carry
out repeat HFMEA analysis. Furthermore,
there is a need for more detailed and thorough research on the effectiveness of
HFMEA analysis in the healthcare processes in general and in paediatric
oncology department in particular.
References
Bonfant G, Belfanti P, Paternoster G, et
al. (2010). Clinical risk analysis with failure mode and effect analysis
(FMEA) model in a dialysis unit. J
Nephrol 23,111-8.
Bonnabry P, Cingria L, Ackermann M, et
al. (2006). Use of a prospective risk analysis method to improve the
safety of the cancer chemotherapy process. Int J Qual Health Care 18,
9-16
Dhamija M1, Kapoor G, Juneja A. (2014). Infusional chemotherapy and medication errors
in a tertiary care pediatric cancer unit in a resource-limited setting. J Pediatr Hematol Oncol. 36(7),
412-5.
Gandhi TK, Bartel SB, Shulman LN, et al. (2005). Medication safety in
the ambulatory chemotherapy setting. Cancer.
104, 2477–2483.
Griffin E. (2003). Safety considerations and safe handling of
oral chemotherapy agents. Clin J
Oncol Nurs 7(6 Suppl.),
25-9.
Jacobson JO, Polovich M, McNiff KK, et
al. (2009). American society of clinical oncology/oncology nursing society
chemotherapy administration safety standards. J Clin Oncol 27,
5469-75.
Johnson, Jeffrey A and Bootman, J. L. (1995). Drug-Related
Morbidity and Mortality: A Cost-of-Illness Model. Arch Intern Med. 155(18), 1949–1956.
DeRosier J, Stalhandske E, Bagian JP, et
al. (2002).Using health care failure mode and effect analysis: the VA
national center for patient safety's prospective risk analysis system. Jt Comm J Qual Improv 28, 248-67.
Robinson DL, Heigham M, Clark J. (2006).
Using failure mode and effects analysis for safe administration of chemotherapy
to hospitalized children with cancer. Jt
Comm J Qual Patient Saf. 32,161-6.
Shebl NA, Franklin BD, Barber N. (2009).
Is failure mode and effects analysis reliable? J Patient Saf, 5,
86-94.
Smith CM. (2005). Origin and uses of primum non nocere-above
all, do no harm. J Clin Pharmacology 45, 371-7
Taylor JA, Winter L, Geyer LJ, et al. (2006).Oral outpatient
chemotherapy medication errors in children with acute lymphoblastic
leukemia. Cancer. 107,
1400–1406.
Van
Tilburg CM, Leistikow IP, Rademaker CMA, et
al. (2006). Health care failure mode and effect analysis: useful proactive
risk analysis in a pediatric oncology ward. Qual Saf Health Care 15,
58-63.
Walsh KE, Dodd KS, Seetharaman K, et al. (2009). Medication errors among
adults and children with cancer in the outpatient setting. J Clin Oncol. 27, 891–896.
Weingart SN, Flug J, Brouillard D, et
al. (2007). Oral chemotherapy safety practices at US cancer centers:
questionnaire survey. BMJ 334, 407-9.
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