`
`
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`GuidelinesGuidelines
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`Implementation Toolkit
`
`Medac Exhibit 2028
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
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`Contents
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`Extravasation guidelines 2007
`
`Introduction to the Extravasation guidelines
`
`Introduction
`
`Overall Goal
`
`Specific Targets and Aims
`
`The Nurse’s Role
`
`Key points to understand from the extravasation guidelines
`
`What is extravasation?
`
`Types of extravasation
`
`When does extravasation occur?
`
`Prevalence
`
`Risk factors
`
`What are the implications of extravasation?
`
`Initial symptoms
`
`Tissue damage
`
`Surgery
`
`Impact on cancer therapy
`
`Other consequences
`
`How is extravasation recognised?
`
`Patient reporting
`
`Visual assessment
`
`Checking the infusion line
`
`Distinguishing extravasation vs. other conditions
`
`How is extravasation prevented?
`
`Standard procedures
`
`Training
`
`Patient education
`
`Equipment selection
`
`Vein selection in peripheral administration
`
`Administering intravenous treatment
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`How is extravasation managed?
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`Procedures and protocols
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`Management – initial steps
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`Management – next steps
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`Antidotes
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`Anthracycline extravasation
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`Extravasation kit
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`Surgery and debridement
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`Documentation and reporting
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`Summary
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`Appendices
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`List of drugs: vesicants, irritants and non-vesicants
`
`Distinguishing extravasation from other conditions
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`Vein selection procedure
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`Administering Savene™ (dexrazoxane)
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`Administering dimethylsulfoxide
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`Administering hyaluronidase
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`Extravasation kit
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`Documentation template
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`References
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`We would like to thank the following people for their guidance in helping to develop these
`documents:
`
`Yvonne Wengström OCN, PhD, Past President of the European Oncology Nursing Society
`(EONS)
`
`Jan Foubert
`
`RPN, PhD, Senior Lecturer in Nursing and Midwifery, Erasmushogeschool,
`Department of Healthcare, Brussels, Belgium
`
`Anita Margulies
`
`BSN, RN, Clinical Nurse and Lecturer, Board Member of EONS, Klinik und
`Poliklinik für Onkologie, Universitätsspital, Zürich, Switzerland
`
`Helen Roe
`
`RN, BSc(Hons), Consultant Cancer Nurse / Lead Chemotherapy Nurse,
`North Cumbria Acute Hospitals NHS Trust; Chair of the United Kingdom
`Oncology Nursing Society (UKONS) North Zone Chemotherapy Group,
`United Kingdom
`
`Sebastien Bugeia
`
`Oncology Nurse at the “Institut Gustave Roussy” (Villejuif, FRANCE), Board
`Member of the French Oncology Nursing Society (AFIC).
`
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`Introduction
`
`With over 100,000 doses of chemotherapy and in excess of 1,000,000 intravenous (IV) infusions
`given every day around the world, keeping adverse events and complications of these
`procedures to a minimum is important both for the patients receiving them and the healthcare
`systems in which they take place.
`
`Extravasation is a serious condition that warrants special attention from the healthcare
`professionals involved in administering intravenous medications. This educational module
`summarises and explains the most recent literature and recommendations on extravasation in
`the clinical setting – from prevention and recognition to possible treatment with antidotes. It
`also provides an outline of the pivotal role that nurses play in the patient management process.
`
`The scope of this document is to describe and explain the prevention, recognition and
`management of extravasation in general terms. More detailed descriptions of techniques for
`proper cannulation or phlebotomy (an important skill for the prevention of extravasation) will
`not be dealt with in this guideline.
`
`Overall Goal
`
`Specific Targets and Aims
`
`The Nurse’s Role
`
`Overall Goal
`
`The overall goal of these guidelines is to help nurses understand and recognise extravasation,
`and improve the prevention and overall management of extravasations in cancer patients.
`
`Specific Targets and Aims
`
`The targets and aims of this module are to:
`
`■ Increase nurses’ knowledge of specific elements of extravasation:
`
`씲 Causes and risk factors for extravasation
`
`씲 Features and symptoms of extravasation
`
`씲 Differences vs. flare and other reactions
`
`씲 Consequences of extravasation
`
`씲 Prevention measures
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`씲 The use of antidotes in treating extravasation
`
`■ Encourage successful management of extravasation
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`■ Update and inform nurses of the current standards from different guidelines and protocols
`
`■ Encourage adoption of procedures for extravasation that fit with the current guidelines
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`Table of contents
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`The Nurse’s Role
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`Nurses are among the best placed professionals to recognise and deal with extravasation in the
`clinical setting. The nurses who routinely provide cancer therapies intravenously (either
`peripherally or through central venous access devices (CVADs) are particularly important in the
`ongoing management of this possibly serious complication of therapy.
`
`Nurses have a key role to play in identification and management of extravasation, and, of course,
`in preventing it. From maintaining a high standard of care in the delivery of IV drugs to
`managing the treatment strategy for extravasation, they have many important duties in this area.
`
`Nurses represent an important link for ensuring that extravasation is prevented, diagnosed and
`managed where possible. Their role in providing information and providing ongoing support for
`patients relating to cancer therapy (and the need to be vigilant for any symptoms) is critical in
`cutting the incidence of extravasation.
`
`This module will discuss the role of the nurse in extravasation management and highlight
`information and issues that will assist nurses to perform these roles more efficiently.
`
`Table of contents
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`What is extravasation?
`
`In a general sense, extravasation refers to the process by which one substance (e.g., fluid, drug)
`leaks into the surrounding tissue.1 In terms of cancer therapy, extravasation is defined as the
`accidental leakage from its intended compartment (the vein) into the surrounding tissue.2
`Usually, this occurs when intravenous (IV) medication passes from the blood vessel into the
`tissue around the blood vessels and beyond.1–4
`
`A broader definition of extravasation includes the resulting injury. Depending on the substance
`that extravasates into the tissue, the degree of injury can range from a very mild skin reaction to
`severe necrosis.4
`
`Types of extravasation
`
`Types of extravasation
`
`Extravasation can be classified according to the reaction that is caused by the substance passing
`into the surrounding tissue. Many different drugs have been classified according to the type of
`reaction they cause; however, for the purpose of this discussion, we will refer only to cancer
`therapies. It should be noted, however, that cancer therapies are not the only drugs that cause
`damage when extravasated, and non-cancer therapies (e.g., aminophylline, calcium solutions,
`hypertonic glucose, phenytoin, total parenteral nutrition, X-ray contrast media) can be equally as
`destructive.5
`
`Cancer drugs can be grouped into 3 broad categories, based on their potential to cause tissue
`damage upon extravasation:3
`
`■ Non-vesicants
`
`■ Irritants
`
`■ Vesicants
`
`Non-vesicants do not cause ulceration. In fact, if they are extravasated, they rarely produce an
`acute reaction or progress to necrosis.3 Irritants, on the other hand, do tend to cause pain at, and
`around the injection site, and along the vein. They may or may not also cause inflammation.
`Some irritants do also have the potential to cause ulceration, but only in the case that a very
`large amount of the drug is extravasated into the tissue.3
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`Vesicants are drugs that have the potential to cause blistering and ulceration and which when
`left untreated, can lead to the more serious side effects of extravasation such as tissue
`destruction and necrosis.3 These drugs can be sub-classified according to the mechanism by
`which they cause damage, which is also important since it affects the management strategy.3
`
`■ DNA-binding: These drugs are absorbed locally and enter the cells, bind to nucleic acids (i.e.,
`DNA) and precipitate the death of the cell. Following cell death these agents can be re-
`released to destroy non-cancer cells. They can be divided into 3 categories:3
`
`씲 Anthracyclines
`
`씲 Alkylating agents
`
`씲 Others
`
`■ Non-DNA-binding: These drugs initiate cancer cell death by mechanisms other than binding
`DNA. They can be divided into 2 groups:3
`
`씲 Vinca alkaloids
`
`씲 Taxanes
`
`For a comprehensive list of vesicants (including all subcategories), irritants and non-vesicants
`please refer to Appendix 1.
`
`Table of contents
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`When does extravasation occur?
`
`In an ideal situation, extravasation of vesicant cancer therapies would never occur. Despite the
`many precautionary measures in place, accidental extravasation does still occur, both from
`peripheral lines and from CVADs.
`
`Prevalence
`
`Risk factors
`
`Prevalence
`
`Extravasation is not as rare as some people may think. In cancer therapy experts estimate that it
`accounts for 0.5% to 6.0% of all adverse events associated with treatment.4 But, when you
`consider that adverse events with cancer therapy are quite common, the absolute number of
`extravasations which take place is significant.6
`
`Data regarding extravasation from CVADs is more limited. One small study estimated that
`extravasation occurs about 6% of the time.4
`
`Risk factors
`
`Some extravasations can be accounted for by error in the IV procedure, etc.4,7 However, patients
`receiving these cancer therapies may have multiple risk factors that make IV infusion very
`difficult. For example, cancer patients – with a tendency for thin, fragile and mobile veins – are at
`higher risk of extravasation than the general population.4
`
`In addition to factors relating to the procedure and to the patient, factors associated with the
`equipment/material used, concomitant medications and the treatments themselves can also
`increase the likelihood of extravasation. Some the most common factors known to increase the
`risk of extravasation are listed below:4,8-10
`
`■ Patient factors
`
`씲 Small blood vessels (e.g., infants and young children)
`
`씲 Fragile veins (e.g., elderly, cancer patients)
`
`씲 Hard, sclerosed veins
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`씲 Mobile veins
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`씲 Impaired circulation (e.g., cannula sited on side of mastectomy, lymphoedema)
`
`씲 Obstructed vena cava (elevated venous pressure can cause leakage)
`
`씲 Pre-existing conditions (diabetes, peripheral circulatory conditions like Raynaud’s syndrome,
`radiation damage)
`
`씲 Obesity
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`■ Trouble reporting symptoms early
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`씲 Inability to report stinging/discomfort (e.g., sedated, confused)
`
`씲 Decreased sensation (e.g., as a result of neuropathy, diabetes, peripheral vascular disease)
`
`■ Cannulation and infusion procedure
`
`씲 Untrained or inexperienced staff
`
`씲 Multiple attempts at cannulation
`
`씲 Unfavourable cannulation site (e.g., back of hand vs. forearm, close to bone)
`
`씲 Bolus injection
`
`씲 High flow pressure
`
`■ Equipment
`
`씲 Steel butterfly needle
`
`씲 Catheter size and type
`
`■ Treatment
`
`씲 Ability to bind directly to DNA
`
`씲 Ability to kill replicating cells
`
`씲 Ability to cause tissue or vascular dilatation
`
`씲 pH
`
`씲 Osmolality
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`씲 Characteristics of diluent
`
`Table of contents
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`What are the implications of extravasation?
`
`In general, extravasation is to be avoided. Even in patients who do not progress to ulcerative and
`necrotic tissue damage may still experience pain and discomfort, as well as indirect
`consequences, such as disruption of treatment and committing hospital resources to the
`management of extravasation.3,4 The specific symptoms of extravasation, as well as their wider
`consequences, are discussed in this section.
`
`Initial symptoms
`
`Tissue damage
`
`Surgery
`
`Impact on cancer therapy
`
`Other consequences
`
`Initial symptoms
`
`The initial symptoms of extravasation occur immediately after the blood vessel has been
`breached. Depending on the agent and the patient extravasation may be accompanied by
`discomfort or pain, which can range from mild to intense. Patients often describe the pain as a
`burning sensation.4
`
`The pain may be followed, in the next few hours, by erythema and oedema near the injection
`site.3 In addition, there may be discolouration or redness of the skin near the site.4
`
`The initial symptoms of extravasation are subtle, however, and can be similar for the
`extravasation of different agents (i.e., irritants vs. vesicants). The progression from these initial
`symptoms, however, differs greatly for irritants and vesicants – particularly relating to
`permanent damage to the tissue.3
`
`Tissue damage
`
`Vesicants, by definition, have the potential to cause tissue damage upon extravasation from the
`vein. Like the initial symptoms, the extent of tissue damage can vary greatly between different
`treatment regimens and patients.4
`
`Tissue destruction caused by leakage of vesicants into surrounding tissue may be progressive in
`nature, and may happen quite slowly with little pain. Induration or ulcer formation is by no
`means an immediate phenomenon – as it takes time to develop.5 In general, tissue damage
`begins with the appearance of inflammation and blisters at or near the site of injection.
`Depending on the drug and other factors, this can then progress to ulceration, and then in some
`
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`cases may progress to necrosis of the local tissue.5 Necrosis can occasionally be so severe that
`function in the affected area cannot be recovered and surgery is required.5
`
`If extravasation occurs in the forearm, the damage to tissue includes skin and subcutaneous
`tissue damage. If the extravasation occurs next to a nerve, ligament or tendon, then the damage
`can extend to that tissue and have an impact on sensation and function.11
`
`Surgery
`
`If vesicant extravasation is not recognised and dealt with promptly, the tissue damage can
`become so severe that surgical debridement and plastic surgery (possibly including skin
`grafting) may become necessary.5 In the event that extravasation does affect nerves, ligaments
`or tendons, the damage may necessitate more extensive surgery.4
`
`It is estimated that one third of vesicant extravasations give rise to ulceration. This ulceration, in
`combination with pain and necrosis, can be an indication for surgical intervention.5,12
`
`Impact on cancer therapy
`
`Most extravasation protocols call for the immediate cessation of the drug delivery, followed by
`measures to prevent further spread of the cancer drug into the tissue.8,13–16 As a result, the
`delivery of cancer therapy may be delayed until the extravasation is resolved.
`
`Some guidelines specifically address the issue of re-establishment of IV cancer therapy –
`recommending the establishment of an IV site in another limb.13 However, most guidelines do
`not specifically address this process.8,14–16
`
`Other consequences
`
`Apart from the physical consequences, extravasation can lead to longer hospital stay, more
`consultations and increased length of follow-up care; the need for physical therapy; high
`treatment costs; psychological consequences (e.g., distress, anxiety); and even lost wages.4 In
`addition, it is not uncommon for hospitals and their staff to be faced with a lawsuit following an
`extravasation.5
`
`All of these factors contribute to the seriousness of an extravasation, and can add to the toll on
`the patient, their family and the healthcare system. One of the primary goals of extravasation
`protocols and guidelines is to educate healthcare professionals about the avoidance of serious
`complications and preventions of extravasations before patients require surgical processes.
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`Table of contents
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`How is extravasation recognised?
`
`It is critical that an extravasation is recognised and diagnosed early. The most effective way to
`recognise and detect extravasation in its early stages is to be aware of and act on all relevant
`signs and symptoms. Telltale signs and symptoms can be gathered from patient reports, simple
`visual assessment of the injection site, and careful monitoring of the IV device. Then, once an
`extravasation is suspected, it will also be important to rule out other possible conditions, such as
`flare reaction.4,7
`
`The quality of the nursing assessment during administration can play a key role in minimising
`frequency and severity, since delays in the recognition and treatment of vesicant extravasation
`increase the likelihood of developing tissue damage and necrosis.4,17
`
`Since extravasation could have serious consequences, a second opinion is always warranted. If
`there is any doubt as to whether or not it has occurred, stop and ask for help.
`
`Patient reporting
`
`Visual assessment
`
`Checking the infusion line
`
`Distinguishing extravasation vs. other conditions
`
`Patient reporting
`
`Patients need to know the possible side effects of the treatments they are receiving. In the case
`of extravasation, it is recommended that the patient be told about the possible complications
`and to be aware of any pain/sensation at the site of infusion. Patients should feel that they can
`report any strange sensations as soon as they arise, so the healthcare team can take these
`symptoms into account.
`
`The most important patient-reported symptoms for assessing extravasation relate to the
`sensation around the site of injection – or, in the case of a central line, around the CVAD and
`surrounding area. Typically these complaints include:8,18
`
`■ Pain
`
`■ Swelling
`
`■ Redness
`
`■ Discomfort
`
`■ Burning
`
`■ Stinging
`
`■ Other acute changes at the site of extravasation
`
`None of these are confirmation of an extravasation on their own, but should be treated with
`concern and warrant further examination, such as testing the patency of the infusion with blood
`return. In addition, the nature of the complaints should be verified against the signs and
`symptoms of other possible diagnoses.
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`Table of contents
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`Visual assessment
`
`Visual signs, while by no means exclusive to extravasation, do provide useful confirmation for
`patient reports in suspected extravasation. The common signs, occurring at or around the site of
`the cannula – or, in the case of central line around the CVAD and the surrounding area –
`include:8,18,19
`
`■ Early symptoms
`
`씲 Swelling/oedema
`
`씲 Redness/erythema
`
`■ Later symptoms
`
`씲 Inflammation
`
`씲 Induration
`
`씲 Blistering
`
`Importantly, many of these symptoms do not occur immediately upon infusion. Induration and
`blistering, in particular, tend to appear later in the extravasation process. Therefore, careful
`monitoring of the site should continue during the infusion time and for some time following an
`infusion.7
`
`Checking the infusion line
`
`Apart from patient reporting and visible symptoms of extravasation, it is possible to determine
`whether extravasation has occurred by checking the infusion line itself. Verification of the line
`should be used to help confirm any suspected extravasation (peripheral or central line), if
`possible.
`
`Signs of extravasation, in relation to the cannula, include:8,18
`
`■ Increased resistance when administering IV drugs
`
`■ Slow or sluggish infusion
`
`■ Change in infusion flow
`
`■ Lack or loss of blood return from the cannula
`
`Look for blood return (flashback) upon insertion of the needle. If the needle is in the lumen of
`the vein, you should notice some blood return. If you confirm blood return, the cannula can be
`glided carefully into position, ready to stop if met with any resistance.
`
`Brief blood return may be seen if the needle passes through the lumen of the vein and then out
`the other wall. However, the return will halt once the needle has passed the posterior venous
`wall.20 If this occurs, the needle has passed through the lumen and anything infused will be
`administered straight into the surrounding tissue. The cannula should be removed and the
`procedure recommenced using another vein, if necessary in another vein above the original site
`on the same vein (closer to the heart).7
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`Table of contents
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`Distinguishing extravasation vs. other conditions
`
`Distinguishing between extravasation and other local reactions is an important step in
`diagnosis. Initially, making the distinction can be very difficult and requires sound clinical
`judgment. Familiarity with the different symptoms increases the likelihood of appropriate
`treatment. In the case of extravasation, that means that interventions and management will be
`initiated at an early stage and help to prevent some of the more serious consequences
`associated with it.4,8
`
`Other conditions that resemble extravasation include:4,7,8,18
`
`■ Flare reaction
`
`■ Vessel irritation
`
`■ Venous shock
`
`■ Phlebitis
`
`■ Hypersensitivity
`
`The principal differences between extravasation and these conditions relate to the nature and
`timing of the patient’s complaints, the type and extent of erythema noted and the location and
`presence of swelling.4,8 A guide describing symptoms and differences between conditions
`commonly associated with IV infusion can be found in Appendix 2.
`
`Table of contents
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`How is extravasation prevented?
`
`The most important approach to minimising the consequences of extravasation is prevention.12
`Healthcare professionals involved in the handling and administration of IV cancer therapies
`should become familiar with their local procedures and protocols and develop an
`understanding of the important precautionary steps that should be taken to avoid extravasation
`and the resulting injuries.
`
`Given this cautious and systematic approach, most episodes of extravasation can be avoided
`altogether.21 The following sections provide advice for good practice and may help prevent
`extravasation and minimise injury.
`
`Standard procedures
`
`Training
`
`Patient education
`
`Equipment selection
`
`Vein selection in peripheral administration
`
`Administering intravenous treatment
`
`Standard procedures
`
`Local policies and protocols for preventing, identifying risk factors, diagnosis, and managing
`extravasation represent one of the best ways with which to combat extravasation in the clinical
`setting. The protocols should be drug specific and be developed with input from the whole
`healthcare team involved.
`
`If they are already in place, efforts should be taken to make them readily available to all who
`require them (i.e., those healthcare professionals involved in the administration of IV cancer
`therapy).22 If protocols do not exist, efforts should be made to formally document the local
`procedures for dealing with extravasations.
`
`There are several examples of existing policies and protocols; some of them can even be found
`online (see references section).2,13–16
`
`Training
`
`As mentioned above, local policies and protocols are very important for the delivery of quality
`cancer care. As well as making these documents available, active education of the relevant staff
`members including doctors, would help to keep the standard of care at a consistently high level
`across the board.18 All staff should be encouraged to regularly review the relevant literature on
`cytotoxics handling and relating to new agents, as part of their ongoing training.22
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`Those involved in the administration of IV cancer therapies should be educated on the
`techniques of IV infusion as well as the local organisational policies for:18
`
`■ Venous access
`
`■ Venous assessment
`
`■ Administration of chemotherapy
`
`■ Management of extravasation
`
`■ Management of hypersensitivity, etc.
`
`Patient education
`
`With regard to extravasation, communication with the patient is very important, since they are
`being relied upon to report symptoms critical in its recognition.
`
`Using positive language, patients should be told about the nature of the cancer therapy they are
`receiving and the real possibility of side effects. They should be asked to report any change in
`sensation, stinging or burning, no matter how insignificant it appears to them. An informed
`patient can then help to recognise extravasation early and should always be listened to.11
`
`In addition, training relating to meeting the information needs of patients within cancer care, for
`example presenting a positive approach to delivering information vs. a negative one: “XXX is a
`possible side effect, but we can’t predict your reaction; most patients take these drugs and
`tolerate them well.”11
`
`Equipment selection
`
`The choice of equipment/material for administering cancer therapy is important when trying to
`minimise the risk of extravasation. Important considerations include the size and type of cannula
`or catheter, and whether to use a subcutaneous device or a central line.
`
`In general, the goal is to choose a needle that is least likely to become dislodged, and one that
`allows the blood to flow around it. As a rule, it is advisable to use the smallest gauge cannula in
`the largest vein possible. Specific recommendations include:4,7,12,20
`
`■ Use of a small bore plastic cannula (1.2–1.5 cm long)
`
`■ For peripheral access, short, flexible polyethylene or Teflon
`
`■ Use a clear dressing to secure the cannula – to allow for constant inspection
`
`■ Secure the infusion line, but never cover the line with a bandage (the insertion point must
`always be visible)
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`Vein selection in peripheral administration
`
`The choice of vein for the infusion is an equally important consideration for the prevention of
`extravasation. Finding the largest, softest and most pliable vein is the best choice to avoid
`complications.9 Some general guidelines include:8,12,18
`
`■ Try to use the forearm, not the back of the hand
`
`■ Avoid small and fragile veins
`
`■ Avoid insertion on limbs with lymphoedema or with neurological weakness
`
`■ Avoid veins next to joints, tendons, nerves or arteries
`
`■ Avoid the antecubital fossa (area near the elbow)
`
`For a more detailed overview of vein selection please refer to Appendix 3.
`
`If a first attempt to insert a cannula failed, the second insertion should be made above (closer to
`the heart) the original site if possible. In general, it is thought that it is best to avoid
`administering cytotoxic drugs below a previous venepuncture site.7
`
`Administering intravenous treatment
`
`In addition to careful selection of equipment and veins for administration of IV cancer therapy,
`there are many precautions that can be considered during the infusion to help reduce the risk of
`extravasation.8,12,18,22
`
`Starting IV treatment: 8,12,18,22
`
`■ Become familiar with the manufacturers' recommendations for administration of each
`treatment
`
`■ Dilute drugs to the recommended concentrations and give at the appropriate rate
`
`■ Check blood return from the cannula, or CVAD, prior to administration
`
`■ Before administering therapy, flush the line with saline (sodium chloride 0.9%) or glucose 5%
`(as well as between infusions)
`
`■ Ensure that the cannula is secure during the administration of drugs – the appropriate
`dressing (e.g., IV OPSITE 3000, VecaFix or Tegaderm IV) should be used
`
`■ Never cover the insertion point (i.e., cover cannula site with a bandage)
`
`■ If in doubt, re-cannulate
`
`Monitoring IV treatment:8,12,18
`
`■ Check for swelling, inflammation, redness and pain around cannula site during administration
`of IV drugs
`
`■ Check blood return from the cannula when vesicants are administered
`
`■ Question the patient about any possible symptoms (i.e., heat, pain and swelling during
`administration)
`
`■ Do not allow patients receiving intravenous infusions of vesicant drugs to leave clinical area
`
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`Considerations for vesicants:8,12
`
`■ Whenever possible, always give vesicant drugs into a recently inserted cannula
`
`■ Patients receiving repeated doses of potentially harmful drugs peripherally should have the
`cannula resited at regular intervals – every few days (depending on hospital recommendations)
`
`■ Consider the order of the infusions being given – attempt to administer treatments so
`vesicants present the least risk to the patient
`
`■ A CVAD could be considered if veins are very difficult to access. This might minimise the risk
`of extravasation
`
`■ In no case should a butterfly needle be used for any chemotherapeutic infusion
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`How is extravasation managed?
`
`If extravasation does occur, prevention of serious injury and tissue damage becomes the main
`focus of those involved in the patient management. Swift action is important to limit the
`damage caused by the extravasated drug.22 In general the management of extravasation
`includes detection (covered in the “How is extravasation recognised?” section), analysis and
`action.23
`
`Procedures and protocols
`
`Management – initial steps
`
`Management – next steps
`
`Antidotes
`
`Anthracycline extravasation
`
`Extravasation kit
`
`Surgery and debridement
`
`Documentation and reporting
`
`Procedures and protocols
`
`Just as they play a key role in the prevention of extravasation, local procedures and protocols are
`paramount in the timely recognition and management of extravasation and the prevention of
`serious tissue damage.
`
`If they are already existing, efforts should be made to make them readily available to all who
`need them (i.e., those healthcare professionals involved in the administration of IV cancer
`therapy).22 If protocols do not exist, efforts must be made to formally document the local
`procedures for dealing with extravasations.
`
`It is highly recommended that all healthcare professionals involved in the administration of IV
`cancer therapy should be aware of:22
`
`■ The extravasation policy
`
`■ The contents and whereabouts of the extravasation kit and a replacement kit
`
`There are several examples of existing policies and protocols which can be found online.2,13–16
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`Management – initial steps
`
`Specific courses of action depend on the nature of the drug, how much of it has extravasated
`and where.3 Delays in recognition and treatment can increase the risk of tissue necrosis.
`
`If extravasation is suspected, treatment should begin as soon as possible as commencing
`treatment within 24 hours can reduce damage to tissues, however, extravasation may only
`become apparent 1–4 weeks after the administration.3
`
`No matter what the nature of the drug, if extravasation is suspected the initial response remains
`the same. The most important thing initially is to limit the amount of drug extravasating into the
`surrounding tissue.13–16,22 Depending on your hospital or centre, there may be prescribed steps
`and procedures to undertake before any action is taken (i.e., getting a physician’s signature on
`the extravasation protocol).
`
`In general, the first course of action is to stop the infusion, aspirate as much of the infusate as
`possible, mark the site and then remove the cannula (while continuing to aspirate from the
`extravasation site). Elevate the affected limb and administer analgesia if required.8,15 If possible
`take a digital image of the extravasated area. Then, depending on the drug being infused, the
`correct protocol should be followed to determine the next steps. An example protocol is
`illustrated in Figure 1.
`
`Figure 1. Management of extravasation.8
`
`Step 1 Stop the infusion immediately. DO NOT remove the cannula at this point.
`
`Step 2 Disconnect the infusion (not the cannula/needle).
`
`Step 3 Leave the cannula/needle in place and try to aspirate as much of the drug as possible
`from the cannula with a 10 mL syringe. Avoid applying direct manual pressure to
`suspected extravasation site.
`
`Step 4 Mark the affected area and take digital images of the site.
`
`Step 5 Remove the cannula/ needle.
`
`Step 6 Collect the extravasation kit (if available), notify the physician on service and seek
`advice from the chemotherapy team or Senior Medical Staff.
`
`Step 7 Administer pain relief if required. Complete required documentation.
`
`NOTE: STEP 8 onwards appear in Figures 3, 4 and 5, depending on whether the extravasation
`requires Localisation and neutralisation or Dispersion and dilution. How to determine which
`pathway to follow is described in the following sections.
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`Management – next steps
`
`From this point forward, the nature of the treatment prescribed by the presiding physician or
`hospital policy will depend on the drug, which has extravasated. Figure 2 shows the decision
`pathway as it relates to individual treatments.
`
`Figure 2. Decide on appropriate treatment.8
`
`Decide on appropriate treatment
`
`Amsacrine
`Actinomycin D
`Carmustine
`Dacarbazine
`Daunorubicin
`Doxorubicin
`Epirubicin
`Idarubicin
`Mitomycin C
`Mustine
`Streptozotocin
`
`Vinblastine
`Vincristine
`Vindesine
`Vino