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Oncology

Medication errors in chemotherapy

Medication error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is under the control of the health care professional, patient, or consumer.¹ Medication errors can be classified by considering the types of errors occurring, such as wrong patient, dose, infusion rate, delivery route or medication. Medication errors may occur during any phase of the drug delivery process from prescription to drug administration and at anywhere medications are administered.² Errors may occur with any medication; however, chemotherapy presents unique dangers due to narrow therapeutic indices, potential toxicity even at therapeutic dosages, complex regimens, and a vulnerable cancer patient population.³

Risk: Wrong Dose
Did you know?
Risk: Wrong delivery route for chemotherapy delivery
Products help preventing wrong delivery route
Cost of medivcation error in chemotherapy
Preventive Strategies – Helping to reduce the risk of medication errors in chemotherapy
Risk: Wrong administration technique
Risk: Wrong Patient
Preventing of "wrong patient" errors

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“It may be part of human nature to err, but it is also part of human nature to create solutions, find better alternatives and meet the challenges ahead.”

Linda T. Kohn et al, Committee on Quality of Health Care in America, Institute of Medicine

Past studies have suggested that medication errors account for a significant percentage, if not a majority, of both total medical errors and medical misadventures resulting in mortality. Thus, medication errors are an important subgroup of medical errors due to their frequency, possibility of significant patient harm, and potential for prevention.³ A study revealed that antineoplastic agents were the second most common cause of fatal medication errors⁴ and antineoplastic drugs have been shown to be the drug-class which most commonly associated with medication error, only after anti-infective drugs.⁵

On a general level, of the chemotherapy medication errors reported,

39% involved over- and underdosing, 21% involved schedule and timing errors, 18% involved wrong drugs, and 14% involved chemotherapy given to the wrong patient. Less common errors included infusion-rate errors, omission of drugs or hydration, and improper preparation of drugs. Ten percent of these errors required medical intervention and prolonged hospital stays.⁶

0%

involved over- and underdosing

0%

involved schedule and time errors
0%

involved wrong drugs
0%

involved chemotherapy given to the wrong patient

Risk: Wrong Dose

Generally speaking, wrong drug dosages can occur during all steps of the treatment process. During a 2-year period (2003-2004), Ford³ conducted a prospective study on the oncology ward of a large community hospital on medication errors. They identified 141 errors in total, there of 38 were classified as “wrong dose”. Of these, one occurred during ordering / transcription, 20 during dispersion and 17 during application. Additional 18 errors were “medication not given”.

Case Study: Wrong Dose

In Adelaide (Australia) over a six-month period in 2014 and 2015, 10 cancer patients were given inadequate doses of the drug Cytarabine^{4, 7}

More products that can help minimise medication errors

Did you know?

Of a total of 207 Infusion Bags: ^{8, 13}

0%

were infused too slowly
0%

were infused too fast
0%

were correctlv administered at the prescribed rate

26% were correctly administered at the prescribed rate

Risk: Wrong delivery route for chemotherapy delivery

Most of the chemotherapy regimes are given intravenously, i.e. directly into the venous system. Peripheral venous access may be suitable, however, given the high toxicity of the drugs, mostly central venous access are preferred.

A 6-year-old girl received intrathecal medication during her outpatient treatment. 3 days later she presented at the emergency room with pain in her neck and legs ...⁹

Some of the chemotherapy regimen require other patient access routes, such as intra-arterial access for isolated organ perfusion (e.g. for hepatic metastases) or intra-thecal applications (into the spinal canal, through a lumbar injection).

Cytarabine (Ara-C) can be used intrathecally for carcinomatous meningitis due to lymphoma or leukaemia, and methotrexate can be given intrathecally for carcinomatous meningitis due to breast and bronchial cancers.¹⁰

For example, a patient with highly malignant non-Hodgkin’s lymphoma with cancerous meningitis would typically receive Vincristine 2 mg IV plus Methotrexate 10-15 mg intrathecally.

Some cancers can lead to metastases on the meninges, called carcinomatous meningitis. It occurs often in patients with leukaemia or lymphoma, but also in breast cancer and bronchial cancer or malignant melanoma.

Patients with solid tumors plus carcinomatous meningitis have a poor prognosis. Without treatment, their mean survival time is mostly only a few weeks.

Importance of correct delivery route for chemotherapy

Vincristine is a vinca alkaloid antineoplastic agent intended for iv use only. Vincristine should never be administered subcutaneously, intramuscularly or intrathecally, as this results in necrosis.⁹ Accidental vincristine administration via the spinal route (intrathecally via a lumbar puncture or intraventricularly via an Ommaya reservoir) causes rapid sensory and motor dysfunction, usually followed by encephalopathy, coma, and death.¹¹ Thus it has to be made sure that with combination chemotherapy, each drug is given into the correct patient access port.

Route delivery errors

Route delivery errors, of which intrathecal vincristine delivery is one example (there are many other examples such as intravenous delivery of benzathine penicillin, a galenic depot-formulation for intramuscular use), account for 5% of medication errors.

The specific risks of maladministration of vincristine sulfate were clearly recognized from the early experience in the 1960s.¹³ However, since then, 58 cases of intrathecal vincristine errors are known to have occurred which have been reviewed intensively.^9,12 Out of these cases with inadvertent intrathecal administration of vincristine, only eight patients survived, most of them paralyzed.¹⁴ Specific case reports have been published.^9,14,15

Preventive Strategies

Safeguards used to stop certain drugs being given intrathecally ¹⁶

Most hospitals have strict rules to prevent the administration of vincristine and other vinca alkaloids into the cerebrospinal fluid. The rules at the Great Ormond Street Hospital for Children, London, for example, state that:

Cytotoxic drugs should be given only by specialist, appropriately trained staff
The dose of vinca alkaloid should be diluted to at least 10 ml to help distinguish it from drugs intended for intrathecal injection, for which such a large volume is rarely given
All administration devices containing vinca alkaloids must be labelled: “Warning: Vin…(drug name): For intravenous use only”
Intrathecal drugs should be administered in a designated area — for example, an operating theatre
Drugs for intrathecal use should be delivered to the point of use from the pharmacy at a different time and packed separately from other drugs
No other cytotoxic drugs should be delivered to or stored in such a designated area

Vascular Access

A vascular access port device consists of a catheter connected to a reservoir. It is implanted subcutaneously and namely used to deliver drugs into the blood stream.

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Products help minimising wrong delivery route

The universal Luer connector has been identified as a key element in ‘wrong route’ medication errors. Luer connectors are widely used for delivery of infusions. Literature shows that any patient having multiple access systems in place are exposed to higher risks of misconnections.¹⁷

To reduce the risk of wrong route medication errors the International Organisation for Standardisation (ISO) has developed standards for small-bore connectors, one being in the field of Neuraxial and Regional Anesthesia (ISO 80369-6). Devices that comply with the ISO 80369-6 standard are called NRFit^®. They are 20% smaller in diameter compared to Luer connectors and come with a yellow colour coding.¹⁸

Cost of medication error in chemotherapy

Errors are also costly in terms of opportunity costs. Dollars spent on having to repeat diagnostic tests or counteract adverse drug events are dollars unavailable for other purposes. Purchasers and patients pay for errors when insurance costs and copayments are inflated by services that would not have been necessary had proper care been provided. It is impossible for the nation to achieve the greatest value possible from the billions of dollars spent on medical care if the care contains errors.

But not all the costs can be directly measured. Errors are also costly in terms of loss of trust in the system by patients and diminished satisfaction by both patients and health professionals. Patients who experience a longer hospital stay or disability as a result of errors pay with physical and psychological discomfort. Healthcare professionals pay with loss of morale and frustration at not being able to provide the best care possible and society, in general, pay in terms of lost worker productivity, reduced school attendance by children, and lower levels of population health status.¹⁹

Intercepeted errors, that have not been discovered, lead to 216 additional days of hospitalization.²⁰

Hospital stays	62.248 €
Additional drugs	23.658 €
Total annual cost	92.248 €

Preventive Strategies–Helping to reduce the risk of medication errors in chemotherapy

“Primum nil nocere. ”

– Hippokrates

“It may be part of human nature to err, but it is also part of human nature to create solutions, find better alternatives and meet the challenges ahead”. On their landmark publication in 1999, Kohn and colleagues of Institute of Medicine (IOM) called the entire health care sector to action.¹⁹  The IOM panel called for a transformation in the way health care professionals understand medical error by applying principles from cognitive psychology and human factors, the study of human performance in work environments. Improvements in aviation and other safety-oriented industries, such as chemical engineering, manufacturing, and nuclear power, showed that complex systems, rather than individual practitioners, were the primary sources of error and a target for improvement opportunities through simplification, standardisation, and technology.^21,30

This has in the same year been called the “Swiss Cheese Model”, referring to multiple layers of safety shields to prevent errors (holes in the cheese) to reach the patient.^22,29  This model has been the conceptual foundation for the development of Critical Incident Reporting Systems for the reporting of and learning from critical incidents and near misses.

Product Measure

Standard concentrations pre-prepared by pharmacy or industry , , ,

Product Measure

Standard concentrations pre-prepared by pharmacy or industry

Product Measure

Label/Color Code Concept ^{23, 24} and a Barcode/Data Matrix to handle preparation data and close the loop to patient ²⁵

Product Measure

IV pumps with intuitive handling and integrated drug database ^26,27,28 additionally, compatibility databases ²⁹

Organizational Measures

Comprehensive and interprofessional education and training of all involved staff ^28,29,30,31as well as ward-based clinical pharmacists^30,32

Organizational Measures

Different storage areas for important drugs (e.g. concentrated potassium chloride) ^{33, 38} and introduction of separate medication preparation rooms on ward ³⁴

Incident reporting system ^{30, 35, 36}

The American Society of Hospital Pharmacists (ASHP) consequentially developed a guideline on Preventing Medication Errors with Chemotherapy and Biotherapy in 2002 which has recently been updated.²⁰ The guideline comprises recommendations for health care organisations, for multidisciplinary monitoring of medication use and verification, for prescribing systems and prescribers, for medication preparation and dispensing systems and roles for pharmacists, for medication administration systems and roles for nurses, for patient education, for manufacturers and regulatory agencies, and recommendations for identifying and managing medication errors.

Risk: Wrong administration technique

Wrong administration techniques may comprise multiple aspects of the infusion. One example is discussed in the following:

„Paclitaxel is a chemotherapeutic drug frequently used for breast, ovarial and bronchial cancer. The drug is likely to form microbubbles and particulate matter. The suppliers recommend that an in-line IV filter should be used during the infusion of the agent (SmpC Paclitaxel). Not using the inline filter might result in particles being infused into the patient ³⁷.“

Particles arising from infusion therapy may induce or aggravate inflammatory response syndromes. They have been shown to generate thrombosis, impair microcirculation, and modulate immune response. Sources of particles include components of infusion systems, incomplete reconstitution of solutions or drug incompatibility reactions. Up to one million particles may be infused per patient per day. In-line filters incorporated into infusion lines retain particles and thereby nearly entirely prevent their infusion.⁴¹

Others would be errors in assembling giving sets for secondary infusions with or without pumps, Luer access-devices unintentionally left open after use or needlestick injury due to needle-based manipulation.

Products that help preventing medication errors

Cyto-Set® Mix, Cyto-Set® Line

Connection system for Cyto-Set® gravity infusion-, Infusomat® Space, Infusomat® Plus sets.

Sterifix®

0.2 µm infusion filter

Risk: Wrong Patient

Incidents involving patient misidentification (e.g., “wrong patient” errors) are not uncommon in oncology practice. Many of these incidents are near-miss or close-call situations that are averted at some point prior to reaching the patient. Patient misidentification is under-reported and its incidence is unknown.³⁸

Wrong Patient

A nurse asked Mrs. Jackson to come back to the treatment room of an oncologist’s office for chemotherapy ...⁴¹

Prevention of "wrong patient" errors

In 2002, the Joint Commission created its National Patient Safety Goals program. The No. 1 priority: improving the accuracy of patient identification. To meet this goal, health care providers use at least two patient identifiers — usually, name and date of birth. American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society collaborated to create chemotherapy administration safety standards to reduce the risk of error when providing adult patients with chemotherapy and give a framework for best practices in cancer care.^35,39

At a glance:⁴²

Patient misidentification can occur at virtually any point in a patient encounter
Safety systems have the potential to reduce, but not eliminate, “wrong patient” errors because patient care is vulnerable to human error
Proper patient identification begins with patient registration