The Safe Prescribing, Handling and Administration of Cytotoxic Drugs

Transcription

1 Bromley Hospitals NHS Trust Policy for: The Safe Prescribing, Handling and Administration of Cytotoxic Drugs PRODUCED BY Chemotherapy Working Party. Policy No: Version No: Authorisation:: Cancer Users Group Authorisation: Exec group Authorisation Nursing and Midwifery Committee Authorisation: Drugs and Therapeutics N/A Final Version January 2002 Yes Yes Yes Yes Date of authorisation: January 2002 Date of Issue: 14th January 2002 Review date: January 2003 Page 1 of

2 The Safe Prescribing, Dispensing, Checking and Administration of Cytotoxic Drugs In order to prescribe, dispense, check or administer chemotherapy at Bromley Hospitals NHS Trust you must read and comply with this document. PLEASE CAN YOU SIGN THIS REPLY SLIP AND FORWARD TO: HELEN HANNON (ONCOLOGY CLINICAL NURSE SPECIALIST) CHARTWELL UNIT FARNBOROUGH HOSPITAL Name: Job Title: I have received, read and understood the Bromley Hospitals Policy for the Safe Prescribing, Handling and Administration of Cytotoxic Drugs, and the HSC Guidance 2001/02 National Guidance on the Safe Administration of intrathecal chemotherapy. I have also read and understood the local chemotherapy protocols. Signed: Date - 2 -

3 This document has been developed in collaboration between the following Trusts. St. George s Hospital NHS Trust Blackshaw Road, Tooting, SW17 0QT University College London Hospitals NHS Trust, Middlesex Hospital, Mortimer Street, London W1T 3AA Bromley Hospitals NHS Trust, Farnborough Hospital, Farnborough Common, Orpington, Kent BR6 8ND and has been adapted with kind permission from: Royal College of Nursing (1998) Clinical Practice Guidelines: The administration of cytotoxic chemotherapy. Volume 1 - Recommendations. Volume 2 - Technical Report. RCN Publishing Company, Harrow. The working party that collaborated to produce this document included: Catherine Oakley Jane Penny Dr Elizabeth Sawicka Dr Bipin Vadher Helen Hannon Alison Skinner Steve O Connor Lyn Bizley Kay Casson Maggie Comac Jo Downs Nicki Davies Jenny Matthews Jon Patterson Dr Derek Mercer Operations Manager Cancer Serivces Lead Nurse St George s Healthcare NHS Trust Lead Clinician Cancer Services Consultant Haematologist Oncology Clinical Nurse Specialist Haematology Clinical Nurse Specialist Lecturer in Nursing Kings College Aseptic Services Pharmacist Sister Churchill Ward Paediatric Oncology Nurse Specialist Urology Nurse Practitioner Sister Schooling Ward Clinical Nurse Manage, Outpatients/Ambulatory Services Occupational Health and Safety Services Manager Consultant Plastic Surgeon, Bromley Hospital - 3 -

4 1. Introduction 2. Liability 3. Responsibilities 3.1 Medical staff 3.2 Pharmacy staff 3.3 Nursing staff 4. Pharmacy and Facilities 4.1 Purchasing, receipt & storage 4.2 Cytotoxic preparation facilities Cytotoxic reconstitution during working hours Cytotoxic reconstitution outside normal working hours 4.3 Transportation 4.4 Equipment and Facilities 4.5 Ward storage and refrigeration 5. Health and Safety 5.1 Minimising exposure: Disposable gloves Eye and face protection Respiratory protection Aprons and armlets Summary of protective clothing Special groups/avoidance of cytotoxics 5.2 Handling waste and waste disposal Equipment waste Patient waste Cleaning Laundry 5.3 Spillage 5.4 Extravasation Definition of Extravasation Classification of Vesicant Drugs & Specific Treatments Recognising an Extravasation The Technique Patient Education Order of administration Prevention or minimisation of the problems of extravasation Venepuncture site Symptoms of Extravasation Extravasation kits Documentation of extravasation 5.5 Health Surveillance - 4 -

5 6.0 Guidelines for Administration 6.1 The patient 6.2 Drug formulation 6.3 The prescription 6.4 Administration Guidelines 7. Administration of Cytotoxic Drugs 7.1 Oral 7.2 Intravenous The vascular access devise Vesicant, irritant, non-irritant drugs The procedure 7.3 Intravesical 7.4 Intrathecal 7.5 Intrapleural and Intraperitoneal 7.6 Topical 7.7 Intramuscular 7.8 Ambulatory 8. Documentation 9. Education, Training & Competency 9.1 Medical staff 9.2 Nursing Staff 9.3 Pharmacy Staff 9.4 Continuing education and training Table Table 5.4 Table Appendix 5 Recommended gloves for use in handling cytotoxics Classification of vesicant drugs Guidelines for the administration of individual cytotoxics Appendix 1: Appendix 2: Appendix 3: Appendix 4: Appendix 5: Appendix 6: Appendix 7: Appendix 8: Appendix 9: Appendix 10: Spillage procedure and patients. Treatment of extravasation and contents of extravasation pack. Health Surveillance form for exposed staff. Consent form. Guidelines for the administration of individual cytotoxics. Cytotoxic handling competency for nurses who do not administer chemotherapy Cytotoxic Administration Competencies Intrathecal Administration Checklist for Medical Staff Chemotherapy Dispensing Competency for Pharmacy Staff HSC 2001/022 National Guidance on the Safe Administration of Intrathecal Chemotherapy - 5 -

6 1. INTRODUCTION The purpose of this document is to set out the Bromley Hospitals NHS Trust Policy on Prescribing, handling and administration of cytotoxic chemotherapy. This policy is intended to safeguard patients and staff, by defining acceptable standards of practice for all disciplines involved in cytotoxic chemotherapy. This policy should be read in conjunction with Bromley Hospitals NHS Trust Control of Medicines Policy, Intravenous Therapy Guidelines, Local Chemotherapy Protocols, HSC 2001/02 National Guidance on the Safe Administration of Intrathecal Chemotherapy (Appendix 10) and the Royal Marsden Manual of Clinical Nursing Procedures (2000). Copies of the Royal Marsden Manual of Clinical Nursing Procedures should be available in all clinical areas. The term "cytotoxic drug" is generally used to refer to any agent that may be genotoxic, oncogenic, mutagenic or teratogenic. The health risk of any procedure involving cytotoxic drugs stems from the inherent toxicity of the drug and the extent to which workers and patients are exposed. Although in therapeutic doses, some of these drugs are known to produce neoplastic changes in the long term, there is conflicting evidence on the effect of the much lower level of occupational exposure. Cytotoxic administration throughout Bromley Hospitals NHS Trust should be provided by a multidisciplinary team in which doctors, specialist nurses and pharmacists work to approved written protocols to provide integrated care both within the hospital and the community. It is important to note that: A register is kept in the pharmacy department and on the hospital intranet. The register lists designated personnel, who have been trained and authorised to prescribe, dispense, check or administer chemotherapy including intravenous and/or intrathecal. Individuals on the register will complete a reply slip to confirm that they have received and read this document and relevant protocols. A recognised chemotherapy supervisor who signs the register must verify competency. The Oncology CNS and Aseptic Services Pharmacist maintain the register. However it is also the responsibility of the Paediatric CNS and Ward Sisters from all areas that chemotherapy is administered to ensure the register is up to date. Intravenous cytotoxics should only be administered by chemotherapy trained nurses from the register of designated personnel, during 9am 5pm, Monday to Friday. Where regimes take longer than 6 hours these should be commenced between these hours and nurses from the register should be available for the whole of the planned duration of the regimen. Only Haematology staff at Consultant or SPR level should administer intrathecal cytotoxics, following training. Cytotoxic Drugs given outside normal working hours are given in specific and exceptional circumstances. These are subject to discussion with the Lead Clinicians and would include 5 day regimes that fall over a bank holiday period and acutely ill patients e.g. lymphoma, leukaemia and occasionally patients with other aggressive chemosensitive malignancies requiring emergency treatment at weekends. A chemotherapy trained nurse from the register should administer the chemotherapy. Regarding intrathecal chemotherapy, a clear medical need for the procedure to be undertaken out of hours must be made. If a medical case can be made, a consultant must - 6 -

7 undertake the prescribing and administration. Designated Areas Where Chemotherapy May Be Administered Clinical Area Speciality Route of Chemotherapy Administration The Chartwell Unit Haematology/Oncology Intravenous, Subcutuneous, Farnborough outpatients The designated area for Intrathecal Administration is the Treatment Suite Churchill Ward Orpington Paediatrics Hayes Ward and OPD Farnborough Schooling Ward Bromley Haematology/General Medical Inpatients Peadiatric Urology Bedroom. Intravenous, Subcutuneous, I The designated area for Intrathecal Administration is Side Room 22l Intravenous, Subcutuneous Intravesical Planned chemotherapy over an out of hours period would be prepared in advance. For emergency pharmacy support out of hours see FURTHER ADVICE AND SUPPORT CAN BE OBTAINED FROM: Pharmacy ext 4737 Mon-Fri 8.30am to 5pm Chartwell Unit ext 4977/4424 Mon-Fri 9am to 5pm Haematology CNS ext 4423 Bleep 821 Mon-Fri 9am to 5pm Churchill Ward ext 5027 Paediatric Oncology CNS ext 4194 Mon-Fri 9am to 5pm On Call Nurse Held Pager Out of Office Hours 2. LIABILITY The employing authority accepts vicarious liability in situations where staff undertake activities for which they have received appropriate training and are competent to undertake such activities. The activity must lie within the scope of their role and job description and should follow local policy, the UKCC Scope of Professional Practice (1992) and the UKCC Code of Conduct (1992). The employing authority also accepts vicarious liability for the doctors and pharmacists involved in cytotoxic therapy

8 3. RESPONSIBILITIES 3.1 Medical Staff Cytotoxic drugs must only be prescribed by medical staff familiar with their use from the register of designated personnel. The decision to initiate chemotherapy must be made by Consultants. The first cycle of a course of systemic chemotherapy must be prescribed by Consultant Oncologists/Haematologists at SPR1 specialised staff grade/consultant level/lead Clinician Cancer Services for lung patients and for subsequent cycles (if not prescribed by one of the above), medical staff should ask advice of one of the above, for changes of dose or cessation of therapy. All aspects of the chemotherapy process must be considered, this includes protocol choice, accurate dosing, correct administration details, supportive therapies including antiemetics, choice of venous access (i.e. peripheral or central line) and appropriate interval between treatments. The patient must be assessed as to whether they are fit to treat and written consent obtained for treatment. 3.2 Pharmacy Staff The pharmacist is responsible for checking the drug doses, cumulative doses and intervals between treatments. Also for checking that the appropriate chemotherapy drug is prescribed and that dose modifications to previous treatments are maintained (as necessary). The pharmacist will ensure that administration details are correct for the chosen protocol, that duration of treatment is appropriate and associated treatments e.g. antiemetics, hydration are prescribed. The pharmacist is responsible for the safe and accurate compounding of chemotherapy, which includes drug/drug, or drug/vehicle compatibility, labelling, determination of expiry and storage conditions and appropriate presentation of the drug. The pharmacist also has responsibilities to ensure that documentation is completed. All chemotherapy regimes must be checked by a pharmacist, if the prescription does not comply with agreed protocol or the pharmacist has any queries then these are discussed with the appropriate consultant. 3.3 Nursing Staff Registered chemotherapy trained nurses are responsible for administering the prescribed drug and dose to the correct patient, as outlined in the Bromley Hospitals NHS Trust Intravenous Therapy Guidelines (2001), Control of Medicines Policy, the Royal Marsden Manual of Clinical Nursing Procedures (2000) and the UKCC Guidelines, the Scope of Professional Practice (1992) and Guidelines for the Administration of Medicines (2000). They are also responsible for correct storage of drugs before use, and for checking that the dose is correct, that blood results are satisfactory and that any associated treatments - e.g. antiemetics, hydration, are administered. The nurse is also responsible for providing the patient with information regarding the treatment and monitoring the patient during and following treatment. Also liasing with the community nursing team as appropriate to ensure ongoing support

9 4. PHARMACY & FACILITIES 4.1 Purchasing, Receipt & Storage The purchasing, receipt and storage of cytotoxic drugs are carried out in accordance with agreed pharmacy procedures by the pharmacy department. This ensures the effective control of the quality of these products and also applies to "free samples" of drugs. Pharmacy will store the drugs under appropriate conditions with temperature logging. Cytotoxic drugs supplied to the wards, if not used for the treatment session, must be stored in locked medicine cupboards or designated refrigerators. Cytotoxic drugs will not be available as ward stock but dispensed for individual patients, as prescribed. 4.2 Cytotoxic Preparation Facilities Cytotoxic Reconstitution During Working Hours The pharmacy department has a cytotoxic reconstitution unit with positive pressure isolators designed for the safe preparation of sterile injectable cytotoxic drugs. In most situations, reconstitution in a clinical area is unacceptable. Chemotherapy doses must be ordered by 1pm in order to guarantee a next working day reconstitution service. However, doses may be confirmed up to 11am on the day of treatment, dependant on the availability of staff Cytotoxic Reconstitution outside Normal Working Hours Only in extreme conditions should chemotherapy be initiated out of hours, such as a life threatening oncological emergency. If this situation arises call the on-call pharmacist. An emergency on call reconstitution service is available over bank holiday weekends via the on-call pharmacist Transportation Bulk stock drugs must be transported to the reconstitution unit in appropriately labelled containers. Patient ready drugs must be transported in sealed, labelled, semi-rigid containers (envair bag) to clinical areas. Following preparation drugs for intrathecal use are placed directly into the red envair bag which is labelled Intrathecal. Intrathecal drugs are only issued by the pharmacy department to the Consultant Haematologist or Haematology SPR

10 4.4 Equipment and Facilities Ensure that: Safe and appropriate facilities and equipment are available when required for all aspects of chemotherapy administration. Cytotoxic drugs should be administered in an environment which offers optimum conditions for patients and practitioners. It should not be a general thoroughfare. The environment should be safe, and ensure that the practitioner is not distracted or hurried during administration. This should limit unnecessary exposure. Facilities should include easy access to expert help and all the equipment and procedures necessary for the management of emergencies including anaphylaxis, extravasation, acute medical emergencies, accidental spillage, and for disposal of waste. All areas in which cytotoxic drugs are administered must have the following equipment: Emergency bell. Resuscitation equipment. Drugs for the management of emergencies. Extravasation kit. Anaphylaxis Kit Spillage kit. Eye wash / access to running water Electro-mechanical equipment used to assist preparation and administration must be appropriately installed, validated, and have a current maintenance certificate. The equipment must undergo systemic monitoring for consistent performance according to specification. They should also be appropriate for the prescribed purpose, and used by a competent practitioner only (as defined by local written policy) at all times. Staff should use the Medical Devices Agency (MDA) for reporting adverse incidents, and act upon MDA hazard and safety notices. Staff using medical devices must be competent to do so in accordance with Bromley Hospitals Trust Policy. Designated areas for chemotherapy administration include: Adult Haematology/Oncology day care (The Chartwell Unit) Adult Haematology inpatient (Churchill Ward) Paediatric Ward with special interest in children with cancer (Hayes Ward) Paediatric Outpatients Adult Urology inpatient (Schooling Ward) 4.5 Ward Storage and Refrigeration of Cytotoxics Cytotoxic drugs will only be stored on the ward for use that day or the next morning. There should be a designated fridge for cytotoxic drugs requiring refrigeration. Intrathecal drugs will be issued from pharmacy only to the Consultant or SPR in Haematology and will not be stored on

11 wards. If the drug is not given within the 4-hour expiry period the drug is returned to pharmacy and destroyed. Due to the closure of pharmacy at Orpington on a Sunday cytotoxic drugs will be dispensed from pharmacy on a Saturday for Sunday. Check storage requirements for cytotoxic drugs as not all drugs need to be stored in the fridge. If the cytotoxic has been stored in the fridge, they must be allowed to attain room temperature before administration. This is to reduce the risk of infusion bags splitting during the insertion of the giving set and to reduce venous spasm. Administering practitioners must demonstrate competence regarding the technical skills required for their activities. See section 9, Education and Training

12 5. HEALTH & SAFETY 5.1 Minimising Exposure A full COSHH (Control of Substances Hazardous to Health, 1998) assessment must be undertaken in all areas handling cytotoxic drugs yearly (see Bromley Hospitals Health & Safety Policy 1999). The following guidance applies for all staff handling cytotoxics during administration of treatment, handling of patient waste and cleaning of spillage Disposable Gloves Cuts and scratches should be covered with a waterproof dressing to prevent infiltration of the skin if gloves are damaged. Staff with dermatological conditions e.g. eczema should be referred to occupational health for assessment of fitness to operate in this role. No glove material is completely impermeable to cytotoxic drugs. Permeation of cytotoxic drugs depends upon glove thickness and integrity, the properties of the drug/solvents and the contact time with the drug. Since no material is completely impermeable to cytotoxic drugs and permeability increases with time, users should minimise contact and change the gloves regularly. 2 hourly glove changes are mandatory as the maximum duration that one pair can be worn for and continue to offer protection, is uncertain. (Connor1995) A new pair of gloves should be used for each patient Non Powdered Gloves must be used since the powder may absorb cytotoxic contamination. Gloves must be worn at all times appropriate to the task being undertaken. (See Table for details on gloves). Gloves must be changed immediately if damaged or if significant contamination occurs. Hands must be washed thoroughly with soap/detergent, before and after glove application

13 Table Recommended gloves for use in handling cytotoxics (administration, patient waste, spillage handling). Type of Tasks Administration of cytotoxics/dealing with cytotoxic contaminated waste Gloves provision needs to be sterile and non sterile Glove Type No Latex Allergy Description/material Powder-free latex Thickness mm Glove Type Latex Allergy Description/material Non-latex examination gloves (hypoallergenic) Thickness mm OR Nitrile synthetic rubber gloves of appropriate quality & thickness Cleaning up of spillages Industrial thickness gloves greater than mm thickness made from latex with neoprene or nitrile synthetic rubber. Nitrile synthetic rubber gloves of greater than 0.45mm thickness Eye & Face Protection Protective glasses are recommended to be worn when handling chemotherapy and to protect the eyes against dust and splashes. Recommended brands of goggles are Crews protective glasses (ref FX0008). These should be washed and dried after use. Eyewash kits (available from Eyewash Optrex , 1 pack, 3 bottles, Merck 1TTRpck1021E) and spillage kits (available from pharmacy) must be readily at hand for use in all areas where handling any form of cytotoxic occurs Respiratory Protection There is no research evidence to demonstrate that staff administering cytotoxics are at risk from inhalation. Therefore, staff are not required to wear masks during administration Aprons and Armlets Plastic aprons and plastic armlets should be worn by individuals and are available in the spillage kit

14 5.1.5 Summary of Protective Equipment/Clothing to be Used When Handling Cytotoxics Protective equipment recommended for administration of cytotoxic drugs Gloves: See Table Consideration needs to be given as to whether the procedure requires sterile or non sterile protective gloves Plastic apron Recommended goggles such as Crews protective glasses Protective equipment for those handling waste from patients receiving chemotherapy Gloves: See Table Plastic apron Recommended goggles such as Crews protective glasses Protective equipment to be used in the event of a spillage Gloves: See Table Plastic apron and armlets which are available in the spillage kit. Visimask (available in the spillage kit) or a recommended brand of Goggles such as Crews protective glasses Plastic overshoes Special Groups/Avoidance of Cytotoxics Pregnancy/Breastfeeding There should be no significant exposure to cytotoxic drugs if good handling practices are strictly adhered to. There have, however, been some studies suggesting adverse effects on the foetus, as a result of the mother working with cytotoxic drugs. Pregnant staff will not be expected to be involved in directly preparing or administering chemotherapeutic agents or handling waste from patients treated with chemotherapy. If a member of staff who handles cytotoxics knows that she is pregnant she should notify her manager as soon as possible and a referral made to occupational health for risk assessment Staff member s breastfeeding need not be restricted from administering chemotherapy Any other member of staff concerned about handling cytotoxics should arrange to discuss this with the Occupational Health Department 5.2. Handling Waste and Waste Disposal When dealing with patient waste and other contaminated waste, the following approaches must be used: All staff who handle cytotoxic drugs, waste or work in areas where they are used, must have been appropriately trained/educated, supervised and updated regarding: The risks of handling and disposing of waste Appropriate practices for handling and disposing of waste Local policies and protocols, legal requirements, and the principles behind them See appendix 6 for associated competencies

15 It is the clinical staff responsibility to ensure that, in any environment where cytotoxics are administered, the drug is kept safely and securely stored, and disposed of correctly - thus causing no danger to domestic staff working in the area. A domestic should on no occasion be expected to deal with this special waste. Clinical staff should adhere to the Clinical and General Waste Policy (1999), and to the Health & Safety Policy (1999) Equipment Waste Contaminated materials such as bottles, vials and other materials used in the preparation and administration of cytotoxic agents, must be placed in a cytotoxic sharps bin. These are plastic, with absorbent material in the base, and a tight fitting lid, which can be sealed and taped with cytotoxic tape. When full appropriately label with the name of your clinical area. Also placed in the cytotoxic sharps bins are contaminated needles, syringes, giving sets and tubing which, should be disposed of intact. Personal protective equipment i.e. gloves, aprons etc should be disposed of in a yellow clinical waste bag and labelled cytotoxic. The method for disposal of hazardous waste is by incineration. Waste should be segregated and should not be allowed to accumulate. The integrity of the packaging should be safeguarded during storage and transport, and should not expose personnel to any risk Patient Waste Urine, sweat, faeces and vomit may contain high concentrates of cytotoxic or active metabolites for up to seven days after treatment has stopped. As a general rule most patient waste is most hazardous for the first 24 hours (Cass and Musgrave1992). Personnel disposing of patient waste should wear appropriate clothing as per section NB - In the case of intravesical chemotherapy, remember that urine, clothes and linen should be treated with care (urine flushed with some bleach). Soiled linen or nightwear must be disposed of in an inner dissolvable and an outer solid red bag and labelled cytotoxic Cleaning Contaminated equipment, such as ambulatory pumps, must be cleaned and disposed of appropriately, according to the Decontamination of Healthcare Equipment Policy (1999) by trained staff who are aware of the hazards of ineffective cleaning. Contaminated settings must be cleaned appropriately, according to local policie s, by trained staff who are aware of the hazards of ineffective cleaning Laundry Soiled patients bed linen should be treated as infected linen and placed in an inner dissolvable and an outer solid red bag and labelled cytotoxic waste with tape. Patient/staff clothing contaminated with cytotoxic agents or waste from a patient receiving chemotherapy must be removed immediately. Personnel should wear appropriate clothing for dealing with a spillage see section Rinse the clothing under running tap water. Squeeze dry and place in a plastic bag. Uniforms or hospital

16 linen should be placed double red plastic laundry bags and label cytotoxic, then send to the laundry. Personal clothing should be taken home for laundering on the hottest wash. Handle all pre-washed laundry with gloves. If contaminated clothing is non-essential, disposal is advised. For further information see Appendix Spillage (See Appendix 1) The cytotoxic drug spillage procedure should be attached to the COSHH assessment and made readily available for ward use. Managers must ensure that all staff are made aware of the spillage procedures to adopt and the protective clothing that must be worn. A cytotoxic drug spillage kit is available on all wards where cytotoxics are administered and also given to patients who receive cytototoxic treatment at home. Spillage kits are available from pharmacy. All spillages of cytotoxic drugs involving staff or patients must be reported using the standard Incident Reporting Form (IR1) and processed as per the Reporting of Incidents Trust Policy. For advice for patients please see Appendix Extravasation (See Appendix 2) Definition of Extravasation Extravasation is the inappropriate or accidental administration of chemotherapy into the subcutaneous or subdermal tissues rather than into the intravenous compartment. The consequence of this action is often pain, erythema, and inflammation and discomforts which, if left undiagnosed or inappropriately treated can lead to necrosis and functional loss of the tissue and limb concerned. The signs and symptoms of extravasation are well-documented and general consensus reached. The first signs of extravasation may be noticed by the patient, who may say that the injection feels different to previous occasions, or that there is a burning sensation, tenderness or pain. On observation there may be mild redness, blotchy skin, swelling or temperature change. The person giving the injection may also notice a difference in the feel of the injection, with increased resistance or no blood flashback. If the extravasation is missed then discoloration, induration, dry desquamation, blistering, and excessive local tissue destruction and serious complications can occur all of which can be accompanied by discomfort or pain Classification of Vesicant Drugs & Specific Treatments Table 5.4: Classification of vesicant drugs Vesicants have the potential to cause cellular damage or tissue destruction. Injuries caused by extravasation of vesicants can cause sloughing of tissues, severe prolonged pain and loss of mobility. Irritants may produce pain and inflammation at the administration site or along the path of the

17 vein through which they are administered, but do not cause tissue destruction. Vesicant: Group 1 Irritants: Group 2 Non-vesicant: Group 3 Aclarubicin Amsacrine Carmustine Cisplatinum Dacarbazine Dactinomycin Daunorubicin Docetaxel Doxorubicin Epirubicin Idarubicin Mitomycin Mustine Paclitaxel Plicamycin Treosulfan Vinblastine Vincristine Vindesine Carboplatin Etoposide Liposomal Daunorubicin Methotrexate Mitozantrone Asparaginase Bleomycin Cladribine* Cyclophosphamide* Cytarabine Fludarabine Fluorouracil* Gemcitabine Ifosfamide* Melphalan Pentostatin Raltitrexed Thiotepa* Interferons Aldesleukin (IL-2)* The classification of those drugs in Group 3 marked with an asterisk is controversial. While being regarded by some as non-vesicant, others have argued that they represent an irritant hazard to subcutaneous tissues Recognising an Extravasation There may be lack of blood return at the cannula. Pain at the intravenous site may be modest or severe, usually burning and stinging. Persistent pain usually indicates a more severe extravasation injury. There may be erythema, swelling and tenderness. The initial appearance may not indicate the full extent of damage and it may be one or two days before the first evidence of progressive tissue damage. Initially the area may not appear damaged at all. Local blistering is indicative of at least a partial-thickness skin injury. There may also be mottling and darkening of the skin. Early firm induration, with or without tenderness, has been shown to be a reliable sign of eventual ulceration

18 When the full thickness of the skin is damaged, the surface may appear very white and cold with no capillary filling and after one or two weeks may develop a dry, black eschar. This process may take longer, depending on the agent, e.g. 6-8 weeks for cisplatin. The eschar will slough to reveal the underlying ulcer cavity. Ulcers have a typical necrotic, yellowish base with a surrounding rim of persistent erythema. Some cytotoxic drugs can cause flare phenomenon. Flare consists of a erythematous streak along the course of the vein receiving the transfusion and does not imply extravasation. It may be associated with itching or local urticaria but usually disappears within 30 minutes The Technique Multiple attempts at venepuncture before an intravenous device is established may be predispose to leakage, as holes in veins adjacent to the puncture site increase the risk of extravasation. Administration by inexperienced personnel, particularly of cytotoxic therapy, may increase the risk of extravasation. Covering the site of an intravenous devise with sterile drapes of occlusive dressing hides the signs of an extravasation. Fluid forced during manual administration or by infusion pumps with a high maximum flow pressure are more likely to produce injury through extravasation than volumetric pumps. Injection of contrast media by syringe driver or pump (median rate of injection 2.5 ml/sec) as opposed to drip-infusion or hand injection technique results in a higher frequency of extravasation. Steel needles have been shown to cause extravasation more than twice as often as plastic cannulas Patient Education The patient plays an important role in the prevention of extravasation. The patient is the first to notice that something is wrong with the administration, often feeling a stinging or burning sensation or pain. Therefore it is imperative that patient co-operation is gained and adequate information is given, preferably supported by a written information sheet. This will permit early recognition and prompt reporting of these early signs of extravasation (Davis et al 1995) Order of administration Disagreement exists regarding the order of vesicant administration when giving a number of chemotherapy drugs together. As venous integrity declines through the course of successive cytotoxic injections, the vesicant is more likely to be safely administered when given first when the vein is most stable and least irritated (Stuart 1982, Wood & Gullo 1993). For bolus injections, it is important to check patency of the cannula every 3mls by pinching the IV tubing or by gentle aspiration of the syringe (Oncology Nursing Society 19292, Boyle & Engelking 1995)

19 It is not uncommon for cytotoxic drugs to be given via a fast running infusion, this serves the purpose of diluting the drug and subsequently reducing vein irritation and in the event of extravasation, reduces local tissue damage (Seyfer & Solimando 1983). The veins of patients who have cancer are often fragile so nurses must be reassured that if ulceration occurs following careful cannulation and administration of cytotoxic drugs, it is not indicative of negligence (Rudolph & Larson 1987, Boyle & Engelking 1995). Venous spasm occasionally occurs at the beginning of an intravenous bolus injection when the patient may experience pain, making it difficult to differentiate between venous spasm or extravasation. However, pain related to spasm will usually subside within a few minutes (Frogge 1982) Prevention or Minimisation of the problems of extravasation The position, size and age of the venepuncture site are the factors which have greatest bearing on the likelihood of problems occurring. However, if the following points are borne in mind the likelihood of extravasation can be significantly reduced. To ensure patency of a peripheral IV site, it is best to administer cytotoxics through a recently sited cannula. Site the cannula, so it cannot become dislodged, use the forearm and avoid, if possible, sites near joints. Administer vesicants by slow IV push into the side arm post of a fast running IV infusion of compatible solution. The most vesicant drug should be administered first. Assess a peripheral site continually for signs of redness or swelling. Verify patency of the IV site prior to vesicant infusion and regularly throughout, if there are any doubts stop and investigate. Re-site the cannula if the patency of the cannulation is still not entirely satisfactory. Ask the patient to report any sensations of pain or burning in the infusion site. Some investigators suggest delaying the administration of anti emetics until after vesicant administration. The sedative and anti inflammatory effects of anti emetics often mask the early warning signs of extravasation and may impede the patient s ability to report any sensation at the infusion site. Never hurry. Administer drugs slowly to allow the drug to be diluted by the carrier solution and to allow careful assessment of the IV site. Document carefully the rate of administration, location and condition of site, verification of patency and patient s responses, on giving any potentially extravasable drugs. Cancer patients receiving chemotherapy are particularly prone to extravasation because their veins are often fragile, mobile and require multiple punctures (Rudolph & Larson 1987, Graut 1993). These factors are compounded by an increased risk of thrombosed vessels, which inevitably limits the number of accessible veins. Patients with cancer may be debilitated or have other increased risk factors, including superior vena cara obstruction or lymphoedema

20 When cannulating extremities with occluded venous or lymphatic drainage due to these or other conditions should be avoided (Boyle & Engelking 1995). Previous chemotherapy increases the risk of extravasation, and patients who have had radiotherapy at the site of administration may experience severe local reactions in the event of extravasation (Smith 1985). Patients on steroids should be monitored more closely since the inflammatory response may be suppressed and extravasation missed (Porr et al 1989). Once extravasation has occurred, damage can continue for months and involve nerves, tendons and joints. If treatment is delayed, surgical debridement, skin grafting and even amputation may be the unfortunate consequence Venepuncture Site: The site of the cannula (hand, wrist, forearm or cubital fossa) does not significantly affect rates of infusion failure (Hecker 1990). But the majority of the literature suggests that sites of administration most often implicated in extravasation injury are the anticubital fossa and the dorsum of the hand and foot (Linder et al 1983, Smith 1985, Wood & Gullo 1993, Boyle & Engelking 1995). The areas provide little soft tissue protection for underlying structures such as nerves and tendons and should generally be avoided when administering irritant and vesicant drugs as serious injury can occur. The optimum location for administrating of these agents is the forearm, which has superficial veins with sufficient soft tissue to protect tendons and nerves and cannula placement over joint areas must be avoided (Ignoffo & Friedman 1980, Smith 1985). If cannulation fails on the first attempt, then the next attempt should be proximal to the first site or preferably in the other limb, as holes in veins adjacent to the puncture site increase the risk of extravasation (Linder et al 1983, Smith 1985) Symptoms of Extravasation Extravasation should be suspected when: The patient complains of burning, stinging, pain or any acute change at the injection site. The patient is often the first person to become aware that something is wrong with their IV therapy, so instruct them at the beginning of treatment to inform staff of any acute change during treatment. Explain the reason for this in a way, which is not frightening but conveys the need for the patient s input and participation. Given reassurance that, if a leakage should occur it would probably not cause serious problems if the infusion is promptly stopped and the correct treatment instituted. Patient s who are unable to communicate should be particularly closely observed. Induration, erythema, venous discoloration or swelling is observed at the site (discoloration alone may not indicate extravasation as doxorubicin, epirubicin and mitozantrone have been reported to produce this). No blood return is obtained. A lack of blood return from the cannula is commonly quoted as a sign that extravasation has occurred. It is however, the most misleading of all signs and has been implicated in a number of serious incidences. This occurs because although there has been extravasation injury and the cannula has become displaced, the act of trying to draw blood back

21 to test for blood return moves the cannula back into the vein. Thus blood is returned, however, there is a hole in the vein wall in the proximity of the cannula tip. So when administration recommences, a larger and more significant extravasation injury ensues. Alternatively, the bevel of the needle can puncture the vein wall during venepuncture, allowing drug to escape into the tissue whilst the lumen of the needle may still remain in the blood vessel and allow adequate blood return. The flow rate is reduced. A reduced rate may not be observed when using an infusion pump, so close observation is necessary. Increased resistance to the administration, once possible changes in the position of the body e.g. bending of wrist or elbow, or cannula support e.g. the bandaging have been excluded as possible causes of the increased resistance, then a displaced cannula and hence extravasation are the next most likely causes. This is often one of the first signs of a problem or of pre-extravasation syndrome Extravasation kits Extravasation kits MUST be available in all areas where cytotoxics are administered. The procedure for extravasation is outlined in Appendix Documentation of Extravasation Careful recording of the following are recommended: Date and time of incident Needle size, type and insertion site Drug sequence Drug administration technique Approximate amount of drug extravasated Patient's symptoms and statements Appearance of site Physicians notified Follow up procedure Doctors and nurses signature Photograph Posters detailing spillage and extravasation procedures must be displayed in all areas where cytotoxics are administered. These posters are available from pharmacy. 5.5 Health Surveillance The following applies to all staff including pharmacy: Annual Health Surveillance Form Managers should issue a Health Surveillance Form (Appendix 3) annually which should be completed by all members of staff involved in the handling of chemotherapy, whether in administration of chemotherapy or in dealing with patient waste. This contains questions

22 about symptoms and exposures in which the staff member was involved. The completed from should be returned to the Occupational Health Department. Staff members may be reviewed at the Occupational Health Department on the basis of answers to the questionnaire. All members of staff should routinely attend the Occupational Health Department after they have suffered contamination or needlestick incidents. All spillages incidents should be recorded on: an accident form cytotoxic annual health surveillance form for exposed staff: See Appendix

23 6. GUIDELINES FOR ADMINISTRATION 6.1 The Patient Before drug administration, ensure that: Patients receiving cytotoxic drugs have understood as much as they wish to about their treatment; its rationale, process and outcomes. Patients should be explicitly told the nature of the procedure, the route of administration, and the drug to be administered. There are sufficient resources to monitor each patient appropriately Results of all blood counts, investigations and calculations specified by protocol, have been judged to be satisfactory by an appropriately qualified, competent practitioner. Patients receiving cytotoxic drugs have given written informed consent. An example of a consent form can be found in Appendix 4. Patients receiving cytotoxic drugs feel prepared and supported. A consultant or an appropriately trained and nominated deputy from the register of designated personnel has assessed patients receiving cytotoxic drugs. This is to ensure that the patient is fit for treatment, the correct tests have been conducted, and the correct chemotherapy has been prescribed and that arrangements have been clearly made for the chemotherapy to be administered by the appropriate medical or nursing staff. Patients receiving cytotoxic drugs receive appropriate supportive therapy and management of anticipated side effects, including the drugs used to treat anaphylaxis. 6.2 The Prescription Must meet the following guidelines: Safe systems of work ensure that the prescription is clear, unambiguous, accurate, and appropriate for that patient that day. Haematology / Oncology staff should prescribe all cytotoxic drugs using the preprinted chemotherapy prescription charts. Prescriptions for individual areas can be identified as follows: The Chartwell Unit Haematology/Oncology outpatients Doses only require hand writing onto the pre printed white regimen specific proforma. Churchill Ward Haematology Inpatients Hand written on a pink chemotherapy chart Paediatrics Hand written on white cytotoxic chart Schooling Ward Urology inpatients prescriptions for BCG and mitomycin bladder washouts must be prescribed on the pink inpatient chemotherapy chart

24 Hand written prescriptions should be legible and drug names written in full. The total dose of drug must be specified, route of administration, method of administration, frequency of dosing and duration of treatment. Intrathecal route of administration must be written in full. The prescription has been authorised by an appropriately qualified, competent doctor, according to agreed protocols (including clearly specified, agreed regimens which all staff adhere to). Prescriptions including drugs to be given by different routes should be regarded with caution. Administration of the drug by the wrong route can be fatal. The prescription must not include cytotoxic drugs to be administered by both intravenous and intrathecal routes. Intrathecal injections must be prescribed on the separate gold prescription. 6.3 Drug Formulation, Dose Preparation & Administration Ensure that: Drugs doses are fully and appropriately labelled. The right dose of the right drug is administered to the right person via the prescribed route, i.e. with another registered nurse, doctor or pharmacist, check the following details: The date of administration: cytotoxics must be administered on the date stated on the prescription. The drug must be within the expiry date on the label on completion of its administration. The name, dose and infusion fluid (if appropriate) on the pharmacy label must correspond to the prescription chart. Check the patient s wrist label (name and hospital number), or if the patient is an outpatient check their name and date of birth with the patient. The drug formulation and dose are appropriate for the method of administration prescribed. The blood parameters and investigations are within the correct limits for administration These checks should include a two professionals form the trust register i.e. chemotherapy trained nurses, pharmacists, designated medical staff, and the patient, and if appropriate, a relative or guardian in the checking procedure. The checks must be recorded. 6.4 Administration Guidelines Each drug should be administered by the route most appropriate for: The drug formulation The dose prescribed The treatment regimen The goals of treatment The needs of the patient Measure and record vital signs, if appropriate Verify patient's allergy history Assess venous access site (i.e. need for device) Verify patient identity:

25 This should be checked with the chemotherapy trained nurse / doctor who will administer the cytotoxic drugs and another trained nurse, doctor or pharmacist: All inpatients and day cases receiving chemotherapy must wear a patient name band with their name, hospital number and consultant. Check patient name and date of birth with all outpatient chemotherapy patients Initiate pre-treatment therapies, if ordered (e.g. hydration, antiemetics, test dosing)

26 7. ADMINISTRATION OF CYTOTOXIC DRUGS The goals of good practice for administering cytotoxic chemotherapy are to achieve safe practice, patient comfort and therapeutic goals. 7.1 Administration of Oral Cytotoxics Appropriate gloves should be worn when handling containers (see table 5.1.1). The "no touch" principle applies to handling oral preparations of cytotoxic drugs. Whenever possible, tablets should be used in preference to solutions and should be blister or foil packed so that a "no touch" opening technique may be used. In pharmacy departments, only designated counting triangles must be used. If liquids need to be used, advice from the pharmacy department should be sought, about safe handling. Labels on oral preparations should warn all users of the hazards of touching tablets or liquids directly. Crushing tablets, opening capsules or chewing is not recommended. Do not crush tablets. If the patient cannot swallow the tablet, seek advice from pharmacy regarding the possible use of elixir or soluble form. Stop Administration if: There is any doubt about the checks, which have been carried out. The patient requests the treatment to stop. The patient demonstrates side effects or complications, particularly signs of anaphylaxis. 7.2 Administration of Intravenous Cytotoxics The Vascular Access Device Cannula and vascular access devices to be used must be selected and used by a practitioner competent to assess and use them appropriately. See section 9 Education and Training. To provide clinically effective intravenous therapy and minimise the associated complications placing the right device, in the right patient at the right time is essential. Therefore an assessment based on a variety of factors is paramount. Factors for consideration are included in the table below: Therapy Related Factors Type of therapy Length of therapy Device Related Factors Device associated with the least complications Potential complications Maintenance/care Latest technology Cost of placement and aftercare Technical expertise of staff to properly use device Patient Related Factors Suitability/availability of patient veins Self care ability Dexterity of patient Patient preference Co-morbid conditions Patients lifestyle (occupational and recreational activities)

27 Preference for the nurses caring for the device General experience of center No cytotoxic drug should be given if there is any doubt regarding the safety of the venous access device. The administering practitioner must ensure appropriate venous access with regards to: Site Position Patency Integrity Visibility Systematic site management (including dressings) Peripheral venous cannulation Such devices are most suitable for therapies lasting up to 72hours. After this time the risk of complications increases. This is dependent in part, on the PH and osmolarity of the infusate. Current recommendations indicate that cannulae should be routinely changed every hours (Maki and Ringer 1991; Doughherty 1996; Lundren et al 1996). Small gauge, teflon or silicone cannulae which preserve vein integrity and cause least pain to the patient and closed systems with luer lock attachments are mandatory. The superficial veins of the arm, particularly the median, basilic and cephalic veins are the most commonly chosen for the cannulation. These veins are numerous and easily detectable with their wide lumens and thick walls (Marieb 1998). Veins can be identified more easily if heat is applied. (Dougherty 1996) Veins in the lower limbs should not be used and the dominant arm avoided. Other sites to avoid would be the areas of joint flexion, sites distal to recent cannulation or venepuncture, sites proximal to skin lesions or wounds, and limbs where there is lymphatic impairment following surgery, chemical occlusion or radiotherapy. Central Venous Catheters A great deal of evidence indicates that the nature of the infusate administered through a peripheral IV catheter powerfully influences the occurrence of infusion related phlebitis (Maki and Ringer, 1991). Central venous access is the route of choice if the drugs of fluids to be administered are irritant to the peripheral veins or have the potential to cause tissue necrosis should extravasation occur (Weinstein 1997). The Intravenous Nursing Society (1998) recommends that the following drugs and soulutions be infused via a centrally placed VAD(Vascular access device): Infusates with a PH <5.0 and >9.0 Infusates with an osmorlarity of 500mOsm/L Continuous vesicant infusions