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ICID > Clinical Management > Urology > Administration of intravesical chemotherapy  
 

Administration of intravesical chemotherapy 

  •  
  • 1. Indications
  • 2. Clinical Management
  • 3. Patient Information
  • 4. Audit
  • 5. Evidence Base
  • 6. Appendices
    • 1. Indications

    1.1 Background

     

    Bladder cancer is a common disease in the UK, affecting more than 12,500 individuals each year and causing 5000 deaths1. It is the most frequently occurring cancer of the urinary system and accounts for 1 in 20 new cases of cancer each year in the UK.

    Bladder cancer is more common in men than women with a worldwide male: female ration of 3:1.

    About 80% of bladder tumors are confined to the bladder mucosa and called superficial tumors. About 20% are muscle-invading tumors2.

    Bladder tumors may be single or multiple and can occur anywhere in the urothelium but are usually found on the posterior and lateral wall of the bladder especially near the ureteric orifices. They may also be found in the renal pelvis, ureters and urethra3.

    The most common symptom of bladder cancer in approx. 85-90% is painless and intermittent haematuria. Investigation is always necessary, as other causes may be to blame. Other symptoms of bladder cancer include, frequent micturition, dysuria, urgency of micturition.

    Pain, particularly in the suprapubic region, perineum or sacrum is associated with advanced disease. Loin pain may be an indication of ureteric obstruction.

    Patients who present with haematuria undergo a number of investigations, which may include all or some of the following:

    ·         mid stream urine sample

    ·         urine cytology

    ·         Full blood count

    ·         Urea & Electrolytes

    ·         Ultrasound of kidneys & bladder

    ·         Intravenous Urogram

    ·         Cystoscopy

     

    Staging of the tumor is essential for appropriate treatment.

     

     

    Picture supplied by KYOWA.

     

    An accurate assessment of the tumour including depth of penetration into the bladder, involvement of lymph nodes, and spread to other organs are done using the internationally agreed TNM system4.

     

     The pathological grading of tumors, which is based on the degree of anaplasia, is also assessed using the WHO 1973 classification.

    ·         G1 – well differentiated

    ·         G2 – moderately differentiated

    ·         G3 – poorly differentiated

    The stage of the tumour is an important prognostic factor. Superficial tumors have the best prognosis with 90-95% of patients alive, 5yrs from diagnosis5. Patients with muscle invasive tumour have a poorer prognosis.

    Bladder cancer spreads by direct invasion through the bladder wall into adjacent organs. Spread can also occur via the lymphatic system with the pelvic and para-aortic nodes involved leading to circulatory involvement giving rise to metastases in the lungs, liver and bones.

    Intravesical chemotherapy is administered to patients diagnosed with carcinoma of the bladder. The principle behind the treatment is to expose the bladder mucosa to a chemotheraputic agent; thus killing as many malignant cells as possible, but minimising damage to the normal mucosa. It will also reduce the risk of recurrence.

     

     

    1.2 Aim/purpose

     

    The safe administration of cytotoxic drugs.

     

    1.3 Patient/client group

     

    Patients with a diagnosis of bladder cancer under the direct care of a Consultant Urologist.

      

    1.4 Exceptions/ contraindications

     

    This policy does not cover the administration of chemotherapy by any other routes.

     

    Designated Area

    Bladder chemotherapy should only be administered in designated areas: DDU until the service is relocated, Pembroke Unit, Downton Ward, Idmiston Ward, Bishopstone Ward & Day Surgery Theatres only.

     

    When chemotherapy should be administered

    Bladder chemotherapy should only be administered during the "normal working hours" of the Urology Nurse Specialists.

    The only exception being when surgery has taken place on a Friday and chemotherapy needs to be administered 24hrs post-op at a weekend. In this instance a minimum of one Urology chemotherapy-trained nurse should be on duty to ensure safe administration and close monitoring takes place.

    This policy covers the administration of Mitomycin C chemotherapy and BCG Immunotherapy.

    Mitomycin C is administered within 24 hours of bladder tumour resection as a single dose then once a week for 6 weeks. The patient will then have follow up cystoscopies, if further bladder chemotherapy is required the patient will be referred back to the service.

    BCG Immunotherapy commences 2 weeks post surgery to prevent any systemic involvement. BCG is administered once a week for 6 weeks. The patient will then have a Cystoscopy approximately 3 months following treatment. The BCG is then administered at 3 months, 6 months, 9 months and 12 months as "top up immunisation". After this time the patient is put on maintenance therapy which is tapered to the individual.

     

    Prescribers

    Consultant Urologists or a Staff Grade Urologist should prescribe the first dose of bladder chemotherapy on an appropriate chemotherapy chart. Other trained medical staff can prescribe all subsequent doses (See Operational Policy for Chemotherapy within Oncology/Haematology). Pre printed prescriptions will be developed in the near future as the service develops.

     

    Consent

    Written consent must be sought from the patient before bladder chemotherapy can be administered.

    Consent form 3 is to be used where the procedure does not involve any impairment of consciousness.

    (See Policy for Consent to Examination or Treatment)

     

    Transportation and Storage

    An authorised member of the nursing team collects the bladder chemotherapy from the pharmacy department.  Each chemotherapy drug is labeled with specific information on its storage until it is administered. Drugs that require refrigeration must be stored in a separate cytotoxic drug fridge that is lockable.

     

    1.5 Options

    None.
    2. Clinical Management

    2.1 Staff

     

    Nursing

    The administration of prepared cytotoxic drugs is considered to be an advanced practice within this Trust. An advanced practice may be defined as an aspect of care which may be undertaken by registered nurses who have undergone specific training and assessment, accept accountability for their actions and feel competent to undertake the aspect of care.

    In line with guidelines laid down by the NMC on standards for records and record keeping, there must be a current and appropriate plan of care for patients receiving cytotoxic drugs. The plan must incorporate on going evaluation and reassessment of care and evidence that relevant interventions and observations have been communicated to appropriate members of the multidisciplinary team.

    The process for undertaking these advanced practices is:

    1.       Complete the Trust Bladder Chemotherapy Open Learning Pack (accepted as equivalent to N59 at peer review 2001)

    2.       Be assessed as competent in the administration of Intravesical chemotherapy

    3.       Be working as Nurse Specialist in Urology or chemotherapy trained Registered Nurse in the Oncology/Haematology service.

     

    Medical

    Medical staff who are to administer or prescribe chemotherapy should have undergone training in line with the chemotherapy standard (Topic 6 standard 6/11,6/12,6/13) in the Manual Of Cancer Service Standards

     

     2.2 Method/procedure

                                         

    Procedure for the Administration of Mitomycin C  (Mito-In)

    Equipment Required

    Catheter Pack

    1 Urinary Catheter

    1 Catheter Bag

    Disposable gown and apron

    Goggles and mask

    3 pairs of sterile gloves

    Prepared drug to be instilled including Normal Saline for dilution

    Mito-In administration set

    Spillage Kit

     

                   INTERVENTION

                           RATIONALE

    Ensure that pharmacy receives as much notice as possible for prescribed treatment. 

    Enables drug to be ready for collection at the prescribed time.

    Ensure that the patient has a restricted fluid intake 4 hours prior to the procedure.  Diuretics should not be taken until after the treatment.

    This will ensure a low urine output during the treatment, thus preventing dilution of the agent.  The reduced urine output also makes it more likely that the patient will be able to hold the agent for an hour.

    It is preferable that the patient receives the treatment in the morning.

    Encourage the patient to void. Test urine for nitrites, which would suggest possible UTI. (If urine +ve to nitrites delay chemotherapy for 1 week & discuss treatment for UTI with Dr).

    To avoid potentially dangerous outcome of treatment if patient already has UTI.

    Two trained nurses OR a trained nurse & Doctor check the chemotherapy meets the prescription according to the protocol7. Check the identity of the patient with the prescription (Name, Hospital Number & Date Of Birth), and the patient's nameband.

    To ascertain correct drug for correct patient and adherence to the Administration of Drugs Policy.

    Select the correct catheter.  Luer lock or funnel end catheter may be used with Mito-In.

    Apply protective clothing of gown, apron, sterile gloves & mask.

    Ensure that there is a tight connection thus preventing spillage.

    For protection of oneself.

    Reconstitute Mitomycin as per company guidelines. (Appendix 3).

    Remove dirty gown, gloves & apron & dispose of in the cytotoxic bin.

    Ensure safe and correct reconstitution.

    Wash  hands and prepare trolley for catheterisation.

    Explain the procedure to the patient.

    Wash hands and put on clean apron. Apply two pairs of sterile gloves6.

    So all equipment is ready and prepared.

    For informed consent & to answer any questions they may have regarding the procedure.

    To  provide  asepsis.

    Catheterise  patient  as  per  protocol,  using  aseptic  technique.

    If the patient is post-op & has a catheter insitu ensure  that the  3 way  port  is  bunged  and  irrigation  has  been  stopped  prior  to  instillation.

    To  facilitate  instillation  of  treatment.

     

    Prevents  leakage  and  dilution  of  agent.

    Drain  the  bladder  of  any  residual  urine. Obtain and test a urine specimen for nitrites if not previously available. (Follow instruction above if +ve).

    Remove dirty gloves

    Ensures  the  bladder  is  empty. To avoid potentially dangerous outcome of treatment if patient has a UTI.

    To prevent decontamination.

    Instill prepared solution slowly.

    Clamp catheter if to remain in situ.

    Remove catheter if hydrophilic catheter used.

    Aids patient comfort.

    Prevents backflow of the drug.

    Prevents drying out of the catheter.

    Once the chemotherapy is instilled in the bladder remind the patient that the solution is to be retained for 1 hour.

    This may continue at home.

    To ensure that the medication comes into contact with the entire bladder wall.

     

    Reduces patients stay in hospital

    Dispose of all used equipment in the Cytotoxic bin for incineration.

    For protection and safety of oneself and others.

    Refer to waste management policy

    At the end of an hour, or before if the patient is unable to tolerate treatment, reapply safety clothing (apron, gloves etc).

    If the catheter has remained insitu release the clamp & allow drainage of the drug into a catheter bag.

    If the catheter is to remain in situ apply a non-drainable 2-litre bag to the catheter port.  Attach cytotoxic warning tape to the bag. When the bag is full dispose of as cytotoxic waste.

                           OR

    Request that the patient micturates into the toilet, sitting down and explain the reason why. Ensure a dedicated toilet has been identified for bladder chemotherapy patient's use only. (Appendix 2).

    For protection and safety of oneself and others.

     

     

    Prevents spillage of drug.

     

    Allows continued drainage post surgery.

    Alerts staff to the risk of exposure & will warn staff to correctly dispose of the bag and urine.

     

     

    Prevents cytotoxic drug coming into contact with the skin.

    Reduces risk of exposure to other patients.

    If the catheter can be removed, ensure protective clothing worn. Place the catheter & any equipment used into the Cytotoxic bin.

    Protection of oneself & others.

     

    Advise  the  patient  of the need  to  increase their fluid  intake  for the  next  24  hours, a minimum  of  2  litres.

    Encourages  dilution  and  dispersal  of  drug

    Decreases risk of infection.

    Advise the patient again of possible side effects, provide information (Appendix 3) leaflet and ensure the patient has contact telephone number for advice if required.

    Helps to allay anxiety to know a contact available at all time.

    Reinforces the need to inform the hospital if there are any side effects from the treatment

    Ensure that a record of treatment is documented in the patient's case notes and that the administrator & checker of the drug sign the drug chart. 

    Document any complications  or  side  effects  from  the  treatment & any advice given

    Legal requirement to document the patient cares.

                                     

    Procedure for the Administration of BCG  (Immucyst)

    Equipment Required

    Catheter Pack

    1 Urinary Catheter

    1 Catheter Bag

    Disposable gown and apron

    Goggles and mask

    3   pairs  of sterile  gloves

    Prepared drug to be instilled.

    Spillage Kit

     

                   INTERVENTION

                           RATIONALE

    Ensure that pharmacy receives as much notice as possible for prescribed treatment. 

    Enables the drug to be ready for collection at the prescribed time.

    Ensure that the patient has a restricted fluid intake 4 hours prior to the procedure.  Diuretics should not be taken until after the treatment.

    This will ensure a low urine output during the treatment, thus preventing dilution of the agent.  The reduced urine output also makes it more likely that the patient will be able to hold the agent for 2 hours.

    It is preferable that the patient receives the treatment in the morning.

    Encourage the patient to void.  Test urine for nitrites, which would suggest possible UTI. (If urine +ve to nitrites delay treatment for 1 week & discuss treatment for UTI with Dr).

    To avoid potentially dangerous outcome of treatment if patient already has UTI.

    Two Trained Nurses, OR a Trained Nurse and Doctor check the chemotherapy according to the protocol7.  Check the identity of the patient with the prescription (Name, Hospital Number & Date Of Birth), and the patient's nameband.

    To ascertain correct drug for correct patient and adherence to the Administration of Drugs Policy.

    Select the correct catheter.  The  preparation  will  be  reconstituted  in  a  urotainer  bag.

    Ensure  that  there  is  a  tight  connection  thus  preventing  spillage.

    Apply safety clothing, gown, apron, sterile gloves, goggles & mask.

    Reconstitute Immucyst as per drug company guidelines.

    Remove dirty gown, gloves and apron.

    Protection of oneself.

     

    Ensure safe and correct reconstitution.

    Wash hands and prepare a trolley for catheterisation. Put on clean apron.

    Explain the procedure to the patient

    Open packs.

    Wash hands and put on two pairs of sterile gloves6.

     

    To provide asepsis & protection of oneself.

    To gain informed consent

    Catheterise patient as per protocol, using aseptic technique.

     

    To facilitate instillation of treatment.

     

    Drain the bladder of any residual urine. Obtain and test a specimen for nitrites if not previously available. (Follow instruction above if +ve).

    Remove dirty gloves.

    Ensures the bladder is empty & the catheter is in the correct position. To avoid potentially dangerous outcome if the patient has a UTI.

    Prevents decontamination.

    Instill prepared solution slowly.

     

    Aids patient comfort.

    Once the chemotherapy is in the bladder instruct the patient to lie on the abdomen for 15 minutes. After this time the patient may mobilise as desired for the remainder of the 2-hour treatment period.  This may continue at home.

    To ensure that the medication comes into contact with the entire bladder wall.

     

     

    Reduces the time the patient is in hospital.

    Dispose of all used equipment in the cytotoxic bin for incineration.

    For protection and safety of oneself and others. Refer to waste management policy.

    At the end of 2 hours,  (or before if patient unable to tolerate treatment), request that the patient micturates sitting down into a designated toilet. (Appendix 2).

    Disinfect toilet before flushing by placing an Actichlor tablet into the toilet bowl: leave for 15 minutes before flushing.

     

    Prevents cytotoxic drug coming into contact with the skin.

    Inactivates the BCG. Disinfects toilet for the protection of others.

    Advise the patient of need to increase fluid intake for next 24 hours, minimum of 2 litres.

    Encourages dilution and dispersal of drug.

    Decreases risk of infection.

    Advise patient again of possible side effects, provide information leaflet (Appendix 4) and ensure he/she has contact telephone number for advice if required.

    Helps to allay anxiety to know a contact available at all time.

    Ensure that a record of treatment is documented in the patient's case notes and that the administrator & checker of the drug sign the drug chart. 

    Document any complications  or  side  effects  from  the  treatment & any advice given

    Legal requirement to document the patient care.

     

     

    2.3 Potential complications / Risk Management

     

    Spillage (see Protocol for the Management of Cytotoxic Chemotherapy Spillage and Waste Management Policy)

    Drug Error (see Medicines Policy)

    Anaphylactic reactions (See The Emergency Medical Treatment of Anaphylactic Reaction, Resuscitation Council, UK 1999)

     

    2.4  After  care

     

    All patients will receive information on their specific treatment, either from the Drug Company or from Salisbury District Hospital, which has been written by the Urology Specialist Nurses.

    All patients will receive contact telephone numbers for advice and support.
    3. Patient Information
    Patients should receive information about their specific disease and chemotherapy treatment before their first treatment. (Appendix 3 and 4).
    4. Audit

    4.1 Audit Indicators

     

    1.       The patient is to receive written and verbal information according to their individual needs.

    2.       The patient will receive the care according to trust policy and their individual needs.

    3.       Chemotherapy will be administered safely by a chemotherapy trained nurse.

    4.       The patient will be well informed during the process.

    5.       The patient will be given opportunities to express their anxieties and needs during each visit.

    6.       The chemotherapy will be administered in a designated area.

     

    4.2 Audit design

     

    A review of the bladder chemotherapy service will take place after 6 months. The bladder chemotherapy service is being taken over by the Urology Nurse Specialists from May 2004. Problems may be encountered, which will be discussed and solutions found accordingly with the Urology Nurse Specialists, the Chemotherapy Sister and Lead Cancer Nurse all involved.

     

    4.3 User Involvement

     

    Patients will be encouraged to communicate their thoughts on the service, and how improvements may be made.
    5. Evidence Base

    5.1 Sources of information

     

    1.       Cancer Stats, Bladder Cancer UK. Cancer Research UK 2002.

    2.       Bladder Cancer, Clinical Review, British Medical Journal, Vol. 317, 1998.

    3.       Bladder Cancer: its diagnosis & treatment, Nursing times, Vol. 95, NO 41, 1999.

    4.       International Union Against Cancer cited Sobin LH, Wittekind C, TNM Classification of Malignant Tumors, 5th Edition, New York, Willey-Liss, 1997.

    5.       Bladder Cancer: its diagnosis & treatment, Nursing Times, Vol. 95, No 41, 1999

    6.       Urethral Catheterisation (male & female), Clinical Procedure Policy, Salisbury Healthcare Trust, March 1998

    7.       The Joint Council for Clinical Oncology 1994. Quality Control In Cancer Chemotherapy, Managerial & Procedural Aspects, (1st Edition) Oxford:Oxprint Ltd.

               

    5.2 Summary of evidence, review and recommendations

     

    The information contained within this policy has been collated from reputable resources. Attention has been paid to ensure that the administration of Intravesical chemotherapy is not only safe for patients but also for the staff. Administration of Intravesical chemotherapy by Nurses is not a new practice but one that requires robust training and policies. The training and practices should be reviewed annually to ensure that practice remains safe and staff continue to be competent to administer chemotherapy.

    The safe handling of chemotherapy is crucial for the handler. Intravesical Chemotherapy may be frightening for the patient and many myths exist about the side effects. It is vital that the Doctor and Nurse spend time in explaining the treatment and addressing the patient's anxieties.
    6. Appendices

    1.       Mito-In reconstitution guidelines (available on CD Rom)

    2.       Toilet sign: Toilet sign

    3.       Bladder Chemotherapy information – Mitomycin C

    4.       BCG Immunotherapy – Immucyst Company Information
    Document Owner Peter Guy 
    Department
    Review Date
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    Revision Number
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    Please direct comments to the ICID Team at icid.author@salisbury.nhs.uk