CLINICAL GUIDELINE Prescription, Dispensing and Administration of Cytotoxic Drugs For use in (clinical areas): For use by (staff groups): For use for (patients): Document owner: Status: All areas of Trust involved with cytotoxic drug therapy Doctors, Nurses, Pharmacists and Healthcare Support Workers All patients requiring cytotoxic drug therapy Cytotoxic Users Group Approved 1 Contents Page No 2 Purpose 1 3 Introduction 1 4 Roles and Responsibilities 2 5 Training and Accreditation 2 6 Prescriptions 3 7 Dispensing 5 8 Labelling 6 9 Distribution and Storage 6 10 Checking and Administration of Cytotoxic Drugs 6 11 Health & Safety 7 12 References 7 2 Purpose To provide comprehensive guidance to the Trust s staff who are involved in prescribing, dispensing checking and administering cytotoxic drugs to in and out patients within the West Suffolk Hospital. 3 Introduction 3.1 The prescription and administration of cytotoxic medications are active events that require professional judgement. Medications must be prescribed, administered and recorded in a manner which is clearly understood by the prescriber, pharmacist, and practitioner administering the medication in accordance with national and local guidelines and procedures. 3.2 Cytotoxic drugs can be life threatening to patients if prescribed, dispensed or administered incorrectly. 3.3 This policy guides staff on the principles surrounding the prescription and administration of cytotoxic medications. It should be adhered to by all Trust staff and read in conjunction with procedures for prescribing and administering medicines outlined in the West Suffolk Hospital NHS Policy for the use of Medicines. 3.4 This policy does not cover the use of intrathecal chemotherapy. Anyone responsible for prescribing, verifying, dispensing, issuing, checking or administering intrathecal drugs must refer to the Trust s policy & procedure for Intrathecal chemotherapy & national guidance on Intrathecal chemotherapy. Source: Cytotoxic Users Group Issue date: April 2011 Page 1 of 9
3.5 This policy does not cover the use of oral, subcutaneous or IM Methotrexate and Intravessical Mitomycin outside Oncology/Clinical Haematology practice. Anyone prescribing or administering Methotrexate or Mitomycin under these circumstances must refer to local policies. 3.5.1 For oral/subcutaneous use of Methotrexate within Rheumatology, guidelines are available PP(10)234 Prescribing, dispensing and administration of Methotrexate or contact the for the Rheumatology Clinical Nurse Specialist. 3.5.2 For Intravessical Mitomycin within Urology contact the Urology Nurse Practitioners Remove 4. Roles and Responsibilities 4.1 The Cytotoxic Users Group manages and reviews the use of cytotoxic drugs within the Trust including prescribing, dispensing and administration practices. This group meets regularly and includes representatives from: Pharmacy Oncology Clinical Haematology Medicine Surgery Paediatrics Nursing Full Terms of Reference are available from the, Chair of the Cytotoxic Users Group. 4.2 All separate management areas in which patients receive cytotoxic drugs must have written guidelines for the safe prescription and administration of cytotoxic drugs. Such documents should include the following key features: 4.2.1 The respective roles of medical practitioners, nurses, pharmacists and any others involved should be clearly delineated. 4.2.2 Cytotoxic drugs must only be prescribed, reconstituted, dispensed, checked and administered by specialist staff who have received appropriate training and accreditation and whose names appear on the Register of personnel authorized to prescribe, check and administer cytotoxic intravenous and/or intrathecal chemotherapy (held by the Oncology and Haematology Pharmacist). 4.2.3 Training and accreditation processes must be clearly documented. 4.2.4 Procedures for all stages of the processes of prescribing, dispensing, distribution, storage, handling, checking and administration must be documented. 4.3 All staff responsible for prescribing, dispensing, distribution, storage, checking and administration of cytotoxic drugs must adhere to Trust and departmental policies and procedures at all times. 5. Training and Accreditation 5.1 Areas assigned to cytotoxic administration must have documented training requirements for the prescription, dispensing, distribution, storage, checking and administration of cytotoxic drugs. 5.2 All new staff will undergo formal training for the processes outlined above. Source: Cytotoxic Users Group Issue date: April 2011 Page 2 of 9
5.3 All designated areas must maintain records of training and competence. 5.4 An agreed, and regularly updated, list of approved individuals permitted to prescribe, check and administer cytotoxic drugs will be held by the Oncology and Haematology Pharmacist. Managers of individual departments are responsible for maintaining records of staff training and forwarding updates to the Oncology and Haematology Pharmacist at regular intervals. 5.5 Records of pharmacist and technician training will be maintained within the aseptic training manual. 6. Prescriptions 6.1 Medical staff can only prescribe drugs/regimens with the agreement of the D&T Committee ie those on the Trust Formulary or agreed under exceptional circumstances. 6.1.1. For cancer treatment, medical staff can only prescribe those regimens on the WSH Approved List of Chemotherapy Regimens for Malignant Disease. 6.1.2. In the event that a Consultant wishes to prescribe a regimen/drugs not on the agreed list, the prescriber should complete a concession form. This should be forwarded to the Oncology Haematology Pharmacist and approval sought from the D&T committee as appropriate. 6.1.3. Any prescription for an unlicensed medicine, or the use of a licensed medicine outside it licensed indication, must be in line with the Trust policy on The Use of Unlicensed Medicines (CG10048). 6.2 All prescriptions of cytotoxic drugs should be completed by Consultants or assessed Specialist Registrars. They should be signed and dated accordingly and indicate clearly when therapy is to be administered to the patient. 6.2.1 Within Oncology and Clinical Haematology all first cycles of treatment should be prescribed by a Consultant. 6.2.2 Prior to prescribing a cycle of treatment the Oncology/Haematology doctor should undertake an assessment of the patient s physical condition 6.2.3 Prior to the patient receiving cytotoxic therapy, an assessment of the patients psychological, emotional and spiritual needs should be undertaken and documented by the Oncology/Haematology Clinical Nurse Specialist/Trained chemotherapy nurse 6.3 Non specialists who prescribe on going anti cancer mediation should have ready access to appropriate written protocols and treatment plans including guidance on monitoring and treatment of toxicity, 6.4 Unless there are exceptional circumstances, all prescriptions for all parenteral cytotoxics should be completed on pre-printed cytotoxic prescription charts, which include details of the treatment protocol and concurrent medications. 6.4.1 Hand written prescriptions for any parenteral cytotoxics should only be used in exceptional circumstances. Such prescriptions must be signed or countersigned by a Consultant. They must contain all the information specified in paragraph 6.5. Such protocols must be specified and agreed with the Oncology and Haematology pharmacist. 6.5 Pre-printed prescription charts will include treatment and/or prophylactic medication for regimen specific complications ie: IV pre and post hydration Source: Cytotoxic Users Group Issue date: April 2011 Page 3 of 9
Folinic Acid rescue Use of MESNA rescue Prevention of serious hypersensitivity reactions Use of Atropine for cholinergic diarrhoea Prevention of bacterial/fungal infections Delayed nausea and vomiting 6.6 All prescriptions should include: Patient name Date of birth Consultant in charge of patients treatment Ward/department Height Weight Surface area Full blood count results (taken within agreed time frames see CG10091-8) Biochemistry Liver function tests Pertinent organ function test results Clear start and end dates Allergies 6.8 The prescribing doctor must sign and print his/her name on all chemotherapy prescriptions. 6.9 Extreme caution should be taken when transcribing cytotoxic drugs to TTO charts to ensure drug dose, route, frequency and start/stop date correspond exactly with the original prescription. 6.10 All patients must sign a consent form prior to receiving any cytotoxic drug therapy. It is the responsibility of the prescribing doctor to obtain written consent prior to prescribing chemotherapy. 6.10.1 Within Oncology & Clinical Haematology practice: 6.10.1.1 A West Suffolk Hospital Macmillan Unit Chemotherapy Consent form should be used, with an additional Clinical Trial consent form if appropriate. 6.10.1.2 Consent forms should be completed in full with a patient addressograph, treatment for which the patient is being consented and which information sheets have been given to the patient 6.10.1.3 For oncology patients the details should include: For trial treatment, the trial name and arm of the trial. For non-trial treatment, the name of the treatment protocol. 6.10.1.4 For haematology patients the details should include: For trial treatment, the trial name. Source: Cytotoxic Users Group Issue date: April 2011 Page 4 of 9
For non-trial treatment, where a patient is going to be prescribed a specific drug regimen, the name of the treatment protocol should be stated. For non-trial treatment, where a patient may receive a different drug regimen each cycle, the name of the diagnosis should be stated. 6.11 If a course of therapy is altered i.e., a new regimen selected a new consent form should be completed. 6.12 It is the responsibility of the consenting doctor to discuss the treatment intent, scheduling, potential side effects, including specific information about unlicensed medication, and late complications with the patient. 6.13 The prescribing doctor must ensure information is sent to the GP to advise the GP what action should be taken in the event that s/he is contacted by chemotherapy patients with regimen specific complications or symptoms of: Neutropenic sepsis Cytotoxic extravasation Nausea & vomiting 7. Dispensing Stomatitis, mucositis or diarrhoea 7.1 Parenteral cytotoxic drugs will only be dispensed from pharmacy Monday to Friday 0830hrs to 1700hrs. There is NO out of hours service available after the above times and at weekends. 7.2 Parenteral cytotoxic drugs will only be dispensed for the following designated areas within West Suffolk Hospital NHS Trust: Macmillan Unit (Ward and Day Treatment Unit) Paediatric Outpatients Endoscopy unit (Mitomycin) F12 (Methotrexate for Ectopic Pregnancies) 7.3 All other requests for the dispensing of parenteral cytotoxic drugs must be referred to a senior pharmacist. The senior pharmacist must then review the request and consider/undertake the following actions as appropriate: Contact the Ward Manager/Clinical Manager for the area of intended administration to assess the need for an urgent risk assessment Completion of an Trust Incident form Request a protocol/reference from prescriber Contact the Consultant responsible for prescribing the medication, checking on familiarity with this policy Contact the Ward Pharmacist for the relevant ward After consideration of the above, make a decision whether to supply based on the identified risks involved 7.4 All dispensing must be under the supervision of a pharmacist at all times. Source: Cytotoxic Users Group Issue date: April 2011 Page 5 of 9
7.5 All parenteral cytotoxic drugs should be dispensed in a ready-to-use form by the production unit. 7.6 The dispensing against the prescription of all cancer chemotherapy drugs must meet all criteria relevant to section 6 Prescriptions. Where prescribers fail to meet these criteria a written record of this will be made together with an indication of action taken to remedy this matter. 7.7 Sufficient information must be available each time a cytotoxic drug is dispensed. 7.8 Evaluation of each prescription must include verification of the following: Patient details (full name, hospital number, date of birth, diagnosis, allergies) Recognition of the regimen/protocol (an appropriate reference source must be provided by the prescriber or be available on file) Therapy is correct and complies with this reference source Drug doses are calculated correctly against surface area/height/weight, or other relevant clinical criteria The form of administration (route, diluent, volume, infusion rate) is acceptable and appropriate Given all available information, be clinically appropriate for the designated patient All chemotherapy correctly dated 7.9 All dispensing of parenteral cytotoxic drug therapy must take place using an approved worksheet. 8. Labelling 8.1 All labels for parenteral cytotoxic drugs should comply with national regulations and must contain the following information: Contain the words Cytotoxic on yellow labels Intended route of administration Name of the drug Quantity of the drug Vehicle containing the drug (infusion solution as appropriate) Final volume Batch number allocated to the product Expiry date and time where applicable Storage conditions that ensure stability Patients name and location and hospital number Name and address of the cytotoxic dispensary 8.2 All labels for oral cytotoxic chemotherapy should comply with national regulations and must contain the following information: Contains the words Caution Cytotoxic Intended route of administration Source: Cytotoxic Users Group Issue date: April 2011 Page 6 of 9
Name of the drug Quantity of the drug Expiry date and time (not applicable unless short dated) Storage conditions that ensure stability (ie stored in a refrigerator) Patients name and location Name and address of the dispensary 9. Distribution and Storage 9.1 The transport of all parenteral cytotoxic drugs must ensure that the products are secure, leak proof, protected from heat and light, and intended ward/department of use are clearly identified. 9.2 Under normal circumstances cytotoxic drugs will be distributed to the wards detailed in section 7.2 9.3 Parenteral cytotoxic drugs must be packed separately from other drugs 9.4 Only trained personnel should transport parenteral cytotoxic drugs in designated boxes to the designated wards. All such personnel must have knowledge of spillage procedures for cytotoxic drugs and read the relevant production procedures relating to the delivery of chemotherapy. 9.5 Parenteral cytotoxic drugs must be stored completely separately from all other drugs in designated refrigerators or drug cupboards. 9.6 Where products are refrigerated, the refrigerators are monitored for temperatures in the appropriate range. 10. Checking and Administration of Cytotoxic Drugs 10.1 As standard practice parenteral cytotoxic drugs should only be administered within normal working hours ie 0830am to 1700pm 10.1.1 If there are exceptional circumstances in which outpatient parenteral chemotherapy needs to be administered outside these hours, prior agreement should be sought from the Service Manager for Specialist Medicine 10.1.2 If treatment regimens dictate, inpatient chemotherapy may be administered anytime 24 hours a day, seven days a week according to individual schedules. 10.1.2.1 It is the doctor s responsibility to assess the risks posed by administering the regimen out of hours when prescribing the regimen 10.1.2.2 It is the administering nurse s responsibility to assess the risks posed by administering the drugs out of hours and to ensure that appropriate support is available should an emergency occur 10.1.2.3 Unless there are exceptional circumstances bolus vesicant cytotoxic drugs should only be administered within normal working hours ie 0830am- 1700pm Monday to Friday when full support is available should extravasation occur. 10.1.2.4 If schedules dictate that bolus vesicants need to be administered at weekends the administering nurse should plan the administration timing to ensure that a Consultant is on site. 10.1.2.5 All newly diagnosed patients will be assessed by the Consultant who will consider referral to the Cancer Centre if emergency parenteral chemotherapy is required. Source: Cytotoxic Users Group Issue date: April 2011 Page 7 of 9
10.2 Only staff who are on the register of approved personnel and assessed as competent should administer chemotherapy. For the purposes of training new staff, those who are not on the register of approved personnel may only administer chemotherapy in the presence of authorized staff 10.3 Cytotoxic drugs should only be administered within the departments detailed in section 7.1. 10.4 Cytotoxics drugs are only available from pharmacy Monday to Friday 0830hrs and 1700hrs. There is NO out of hours service available after the above times and at weekends. 11. Health and Safety 11.1 Refer to the West Suffolk Hospital NHS Trust policy and procedure for Handling and administration of cytotoxic drugs reference PP(09)034 12. References 12.1 West Suffolk Hospital Approved List of Chemotherapy Regimens for Malignant Disease 12.2 West Suffolk Hospitals Policy for the Use of Medicines. 12.3 West Suffolk Hospitals Intrathecal Chemotherapy Policy 12.4 West Suffolk Hospitals procedure for Intrathecal Chemotherapy Administration 12.5 West Suffolk Hospitals policy for Handling and Administration of Cytotoxic Drugs PP(09)034 12.6 West Suffolk Hospitals policy for The use of Unlicensed Medicines (CG10048) 12.7 West Suffolk Hospitals NHS Trust Health & Safety Manual 12.5.1 Accidents, incidents and near misses (including RIDDOR) 12.5.2 Health surveillance of employees 12.5.3 Management of health & safety at work 12.5.4 New & expectant mothers: Risk assessment 12.5.5 Personal protective equipment 12.5.6 Waste disposal 12.8 www.doh.gov.uk/consent Department of Health Reference Guide to Consent for Examination or Treatment (2001) 13 Development of the guideline Statement of clinical evidence This document has be updated with minor changes to reflect practice. Contributors and peer review The guideline was developed by the Cytotoxic Users Group. The document has been circulated to the D & T Committee, via Dr Clare Laroche, for review and comment to ensure it is appropriate for implementation, for the management of all cancer patients, within the Trust. All feedback was discussed and queries resolved. Source: Cytotoxic Users Group Issue date: April 2011 Page 8 of 9
Distribution list/dissemination method Haematology and Oncology medical and nursing staff and pharmacy staff will receive an internal memo informing them of the location of the new guideline on the Pink Book. Document configuration information Author(s): Other contributors: Approved by: Issue no: 3 File name: Members of the Cytotoxic User Group N/R Supercedes: Version 2 Additional Information: Cytotoxic User Group D&T Committee Medical Directorate Clinical Governance Steering Group Surgical Directorate Clinical Governance Steering Group Support Services Clinical Governance Steering Group Paediatrics Services Clinical Governance Steering Group N/R Source: Cytotoxic Users Group Issue date: April 2011 Page 9 of 9