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Outline
Overview of Clinical Oncology

Guidelines for safe administration of chemotherapy

Patient involvement in treatment regimen

Bibliography

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 At a Glance
Oncology is the field of medicine that is devoted to cancer .

Clinical oncology consists of three primary disciplines:

Medical oncology: treatment of cancer with medicine

including chemotherapy

Surgical oncology : surgical aspects of cancer

Radiation oncology: treatment of cancer with therapeutic

radiation

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 At a Glance
Question : Why cancer patients need special care ?

Answer:

Cancer is life-threatening disease associated with high

morbidity and mortality rates among all populations.

Patients with cancer face risk of physical impairment ,

ineffective individual coping, emotional and psychological
distress as well as social effects.

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 At a Glance
Answer:

The issue of medication safety is highly significant when

anti-cancer therapy (anti neoplastic agents) is used as a
treatment modality due to the high potential for harm from
these agents and the disease context in which they are
being used.

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 At a Glance
Anti neoplastic chemotherapy have a narrow therapeutic
window: the difference between the optimum therapeutic
dose and doses that are too low to be effective and so high
as to produce overwhelming toxicities is often small.

Therefore, our focus in this presentation will be on safety

measures within medical oncology.

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 Statistical Overview
The Institute of Medicine (IOM) estimates that 44000 to
98000 Americans die annually from preventable anti-
cancer medical errors.

In a survey of adult outpatients receiving chemotherapy, 42

(22%) of 193 believed that they had experienced unsafe
care.

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 Statistical Overview
A survey of 1013 health care professionals from 9 oncology
departments in Switzerland reported that 54% observed
their colleagues making potentially harmful errors.

Seventy percent reported sometimes remaining silent

about safety concerns, and 37% reported remaining silent
when they could have helped prevent an incident.

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 Chemotherapy Standards
Staffing-related safety standards:

Each health care facility should establish a process to ensure that

designated personnel have been trained, accredited and are
authorized to provide chemotherapy as a treatment modality.

Competency should be measurable as an indicator of actual ability

to perform the function.

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 Chemotherapy Standards
Staffing-related safety standards:
All staff involved in patients care should be easily identifiable to
the patient according to the discipline and specialty they represent
( nursing, pharmacy, medical, pathology staff) to ensure patient
can direct questions about their cancer treatment to the most
appropriate person.

Students and trainees must be identified to the patient

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 Chemotherapy Standards
Staffing-related safety standards:
All staff involved in patients care should maintain an appropriate
knowledge and skills with processes in place to ensure continuous
professional education. Essential knowledge include:

Principles involved in treating patients with cancer

Basic principles of chemotherapy including mechanism of action,

dosage, methods of administration and scheduling

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 Chemotherapy Standards
Staffing-related safety standards:

Adverse effects and toxicities associated with chemotherapy and

targeted therapy including, early identification, ongoing
monitoring, principles of prevention and management

Chemotherapy protocols commonly used within scope of clinical

practice

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 Chemotherapy Standards
Staffing-related safety standards:

Chemotherapy and targeted therapy medication preparation,

storage and transportation

Principles of safe handling of chemotherapy and targeted therapy

Information and support needs of patients and their families

including psychological support for persons receiving treatment for

cancer

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 Chemotherapy Standards
Staffing-related safety standards:

Ethical and legal issues associated with the use of chemotherapy

and targeted therapy as a treatment modality for cancer

Local policy and procedures as they relate to cancer treatment

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 Chemotherapy Standards
Appropriate staffing numbers and skill mix for all disciplines should

be in place to ensure that safe practices can be followed

effectively.

All staff involved in the management of cancer and chemotherapy

should have access to appropriate resources that include relevant

support services and Information technology systems.

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 Chemotherapy Standards
The use of electronic programs to facilitate the prescribing,
dispensing and administration of cancer therapy is recommended.

Electronic prescribing programs should include safety alerts such

as alerting prescribers to previous adverse drug events.

Prescribing and dispensing programs should be linked to avoid

possible duplication of therapy.

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 Chemotherapy Standards
Procedures and polices should be in place to provide direction and
clear instruction on working practices to staff involved in providing
chemotherapy.

All staff should be familiar with the content of the policies and
procedures and they must be approved, available and up to date
to reflect current practice.

Informed consent for chemotherapy must be documented prior to

initiation of a chemotherapy regimen

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 Chemotherapy Standards
Access to all documentation pertaining to a patients treatment is
an important aspect of safety and includes patients records and
information sources.

Information should be easily accessible and up to date.

The primary patient medical record/chart and all documentation

applicable to the process of providing chemotherapy treatment
should be available to all staff.

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 Chemotherapy Standards
Paper documentation must be legible, organized and up to date.
Important and variable patient data should be made available to
all staff in a timely, easy to read manner i.e. weight, laboratory
results.

If electronic systems are used to obtain information, procedures

should be in place for storage and access of information.

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 Chemotherapy Standards
All chemotherapy should be provided on the basis of a
documented and referenced protocol.

The protocol should come from an evidence-based, published

source wherever possible and there should be a process of initial
review by a multi disciplinary team before a protocol is
implemented in clinical practice.

Protocols should be reviewed on a regular basis for currency and

changes in practice

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 Chemotherapy Standards
The format of the protocol should be:

o Standardized, easily recognizable, clear and unambiguous

o Typed or computer generated, not handwritten

o Protocol templates stored electronically should be in read-only

format to avoid unapproved alterations on the original.

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 Chemotherapy Standards
o Clearly referenced

o Authored, signed and dated with a review date.

o Easily available to all staff. Local intranet sites or the internet are
useful in ensuring access to protocols for all staff including those
outside the specialty or institution.

o Access to the original protocol document should be restricted to

authorized persons.

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 Chemotherapy Standards
A system should be in place for reporting adverse events, incidents
and near misses.

The Root, Cause, Analysis process should be undertaken for

sentinel events and where a near miss could have resulted in a
serous adverse outcome it is recommended the staff undertake a
Failure Mode Effectiveness Analysis.

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 Chemotherapy Standards
The review of process measures (such as rate and type of incidents
and near misses) and outcome measures (such as chemotherapy
related adverse events and readmission rates) should be
undertaken regularly to identify error prone areas that require
modification.

Health care professionals should refer to individual state guidance

on health and safety related to safe handing of chemotherapy.

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 Patient Involvement
Question: How cancer patients perceive safety measures at
their unit?
Answer:
Patients that understand their treatment regimen and
therapy can be valuable in enhancing the medication safety
process.
Patients who know the name of the drug they are receiving
and what it looks like may be valuable in identifying
discrepancies prior to administration.
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 Patient Involvement
All health care professionals have a role in the provision of patient
information with respect to treatment.

The role of the doctor, nurse and pharmacist in providing this

information may vary across institutions however the legal and
professional requirements of each discipline must be considered
and information provision must be carried out by appropriately
trained staff.

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 Patient Involvement
Provision of information should be coordinated across the
disciplines to ensure the patient receives information appropriate
and relevant to their treatment and should be recorded in the
patients medical record as being carried out.

Each patient should be provided with verbal and written

information which should enable the patient to understand the
aims, the effects and the outcomes of the proposed treatment.

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 Patient Involvement
Outpatients, day admitted patients and inpatients should all
receive the same education and information about their
treatment.

With the wealth of information available through the internet it is

useful to provide patients with a list of websites appropriate for
them to obtain further evidence based information on their
disease and treatment.

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 Patient Involvement
The information must be readable and take into account the
literacy competence of the general public.

Information should be given on the first visit and reinforced on

subsequent visits.

Questions regarding compliance, treatment tolerance, and adverse

events must always be addressed at each appointment.

Documentation should include patient feedback reflecting

understanding and engagement.

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 Patient Involvement
Before initiation of a chemotherapy regimen, each patient is given
written documentation, including, at minimum:

Information regarding his or her diagnosis

Goals of therapy

Planned duration of chemotherapy, drugs, and schedule

Information on possible short- and long-term adverse effects,

including infertility risks

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 Patient Involvement
Regimen- or drug-specific risks or symptoms that require
notification and emergency contact information, including:

o How to contact the practice or organization

o Symptoms that should trigger a call

o Who should be called in specific circumstances (oncologist or

other provider)

Plan for monitoring and follow-up, including appointments

with practitioners or laboratory testing
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 Patient Involvement
All patients who are prescribed oral chemotherapy are provided
written or electronic patient education materials about the oral
chemotherapy before or at the time of prescription. Patient
education includes:

The storage, handling, preparation, administration, and disposal

of oral chemotherapy

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 Patient Involvement
Concurrent cancer treatment and supportive care
medications/measures (when applicable)

Possible drug/drug and drug/food interactions

The plan for missed doses

The education plan includes family, caregivers, or others based on

the patients ability to assume responsibility for managing therapy.

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 Bibliography
American Society of Health System Pharmacists ASHP
guidelines on preventing medication errors with
antineoplastic agents. Am J Health Sits Pharm. 2002 Sep
1;59(17):1648-68

Report of the Chief Pharmaceutical Officer. Building a safer

NHS for patients: Sub section Cytotoxic Chemotherapy .
Improving Medication Safety (38840). Department of
Health 2003
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 Bibliography
Criteria for facilities and personnel for the administration of
parenteral systemic antineoplastic therapy. Adopted on
March 3, 2004 by the American Society of Clinical Oncology
2004 Nov 15;22(22):4613-5.

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