NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST

Transcription

1 NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST Medicines Policy: Code of Practice THE PRESCRIBING, ADMINISTRATION AND SUPPLY OF CYTOTOXIC CHEMOTHERAPY FOR ANY INDICATION, AND OTHER DRUGS REQUIRING SPECIALIST HANDLING POLICY Reference CL/MM/013 Approving Body Directors Group Date Approved 28 October 2014 Implementation Date 28 October 2014 Version version 4 Summary of Changes from added in non-medical prescriber Previous Version References to East Midlands Cancer Network removed List of areas authorised to administer chemotherapy placed in appendix 2 Nye Bevan ward removed as and authorised area and Hogarth ward added added pharmacy technician Only ST3 and above or nonmedical prescribers can prescribe oral cytotoxics for cancer indications on the inpatient chart added Appendix 1 NUH oral methotrexate procedure for non-cancer use added Supersedes CL/MM/013 version 3 October 2010 Consultation Undertaken Chemotherapy Strategy Group Individual consultation with specific specialties (full list available from MMC secretary) Paediatric pharmacists team Date of Completion of 10 th September 2014 Equality Impact Assessment Date of Completion of We 10 th September 2014 Are Here for You Assessment Date of Environmental 10 th September

2 Impact Assessment (if applicable) Legal and/or Accreditation Implications Target Audience Multiple- refer to section 10 All NUH staff involved in the prescribing, supply, administration and disposal of cytotoxic medication, and other high risk medicines requiring specialist handling. Review Date October 2017 Lead Executive Medical Director Author/Lead Manager Mo Rahman Head of Pharmacy and Clinical Director for Medicines Management Ext Further Guidance/Information Sonia Gilmore Medicines Management Committee secretary Ext

3 CONTENTS Paragraph Title Page 1. Introduction 5 2. Executive Summary 5 3. Policy Statement 5 4. Definitions (including Glossary as needed) 5 5. Roles and Responsibilities 6 6. Policy and/or Procedural Requirements Prescribing Authorisation to prescribe cytotoxic chemotherapy 6 for cancer indications 6.3 Authorisation to prescribe cytotoxic chemotherapy 8 by non-specialists for continuation of established treatment for cancer or non-cancer indications 6.4 Prescribing of cytotoxic chemotherapy as new 8 therapy for routine treatment of non-cancer conditions 6.5 Prescribing of cytotoxic chemotherapy by a noncancer 9 specialist for a new/novel indication 6.6 Prescribing of cytotoxics for continuation on ettos 9 on discharge 6.7 Non-medical and supplementary prescribers Training for prescribing Consent for cancer chemotherapy Communication Prescription documentation New regimens, deviations from standard regimes, 12 and one-off protocols 6.13 Timeliness of prescribing chemotherapy that 13 requires manufacturing 6.14 Supply of cytotoxic chemotherapy Transport of cytotoxic chemotherapy Administration of cytotoxic chemotherapy Storage of cytotoxic chemotherapy in clinical areas Out of hours supply of cytotoxic chemotherapy from 21 Pharmacy 6.19 Other non-cytotoxic drugs that require specialist 21 3

4 handling 7. Training, Implementation and Resources Impact Assessments Monitoring Matrix Relevant Legislation, National Guidance and 25 Associated NUH Documents Appendix 1 NUH oral Methotrexate procedure (for non-cancer 26 use in adult and paediatric patients) Appendix 2 Areas authorised at NUH to administer parenteral 30 chemotherapy Appendix 3 Cut off time for items requiring manufacture by 32 Pharmacy production unit Appendix 4 Equality Impact Assessment 33 Appendix 5 Environmental Impact Assessment 36 Appendix 6 Here For You Assessment 38 Appendix 7 Certification Of Employee Awareness 40 4

5 1.0 Introduction 1.1 This policy outlines the requirements and responsibilities of staff who are involved in the prescribing, administration, supply, storage and disposal of cytotoxic medicines. It also outlines specific requirements for other related medicines or medicines requiring specialist handling. 2.0 Executive Summary 2.1 This policy covers cytotoxic chemotherapy (i.e. anti-cancer medicines as listed in chapter 8.1 of the BNF) administered via any route for both cancer and non-cancer indications. Other drugs that require specialist handling, such as monoclonal antibodies (e.g. rituximab), or immunomodulating drugs such as thalidomide (as listed in chapter 8.2 of the BNF) are also included. All staff working in areas that use cytotoxic medicines must be aware of the risks and hazards associated with their use. Prescribers and practitioners who administer cytotoxic medicines must be aware of both the immediate and long-term side effects of any cytotoxic medicine administered. 3.0 Policy Statement 3.1 All staff involved in the prescribing, dispensing, administration and disposal of cytotoxic medicines at NUH must be familiar with and adhere to this policy. This policy also applies to prescriptions generated by NUH for Homecare services or for dispensing external to NUH. This policy does not apply to the use of cytotoxic medicines in the Treatment Centre, or in any other non-nuh organisation. For guidance on dispensing and supply on outpatient prescriptions refer to Trust Pharmacy SOPs. 4.0 Definitions 5

6 4.1 Chemotherapy -refers to any drug used as an anticancer agent as in BNF chapter 8 Cytotoxic - an agent that is toxic to cells as in BNF chapter 8 Cytostatic - an agent that inhibits cell growth / multiplication as in BNF chapter8 5.0 Roles and Responsibilities 5.1 Committees MMC are responsible for ratifying and maintaining this policy Chemotherapy strategy group are responsible for keeping a list of authorised prescribers for haematology and oncology Local governance forums- should perform risk assessments as appropriate and implement any controls necessary to mitigate those risks relating to cytotoxic medicines. They should also maintain a list of practitioners who can authorise or prescribe cytotoxic drugs where appropriate 5.2 Individual Officers Individual practitioners- are responsible for following this policy 6.0 Policy and/or Procedural Requirements 6.1 PRESCRIBING Prescribers must adhere to the principles of prescribing as detailed in section CL/MM/006 of the NUH Medicines Policy. Medical students and clinical observers must never write out a prescription for any cytotoxic medicines, even under the supervision of a prescriber who is authorised to prescribe such medicines. 6.2 AUTHORISATION TO PRESCRIBE CYTOTOXIC CHEMOTHERAPY FOR CANCER INDICATIONS Anti-cancer medicines (cytotoxic chemotherapy, small molecule 6

7 targeted treatments and monoclonal antibodies) for cancer indications may only be prescribed within a recognised, approved treatment protocol Intrathecal chemotherapy Only staff who have been trained and assessed as competent in procedures for intrathecal cytotoxics and are on the appropriate register on the intranet may be involved at any stage in the process of prescribing, dispensing, transport, administration and disposal of these medicines. All staff involved with the handling or administration of intrathecal cytotoxics must update themselves at least annually with the Trust intrathecal policy and the National guidance issued by the Department of Health Parenteral chemotherapy Only approved ST3 doctors and above or authorised nonmedical prescribers can prescribe parenteral chemotherapy Oral chemotherapy adult oncology patients: A prescriber of ST3 or above or an authorised non-medical prescriber must prescribe oral cytotoxic chemotherapy to be administered during an in-patient stay in hospital, In exceptional circumstances, ST1 and ST2 doctors may prescribe such medicines on the advice of a specialist of ST3 or above. A Foundation level 1 or 2 doctor must never prescribe oral cytotoxic medicines. For outliers, the clerking doctor must contact the specialist team Adult haematology patients: A doctor of ST3 or above or an authorised non-medical prescriber must prescribe oral cytotoxic medicines for adult haematology patients. For outliers, the clerking doctor must contact the specialist team Paediatric patients: A doctor of ST3 or above or an authorised non-medical prescriber must prescribe oral cytotoxic medicines for paediatric patients Topical chemotherapy (including use for eyes, ENT, skin) Only a doctor of ST3 or above (including clinical fellows) who has undergone a specialist assessment and is deemed competent may prescribe and administer topical cytotoxic 7

8 chemotherapy. 6.3 AUTHORISATION TO PRESCRIBE CYTOTOXIC CHEMOTHERAPY BY NON-SPECIALISTS FOR CONTINUATION OF ESTABLISHED TREATMENT FOR CANCER OR NON-CANCER INDICATIONS Non- cancer indications Examples may include patients admitted on established oral methotrexate (also see Appendix 1 of this policy) or hydroxycarbamide treatment etc. for non-cancer indications. Any grade of medical staff or a non-medical prescriber who has this on their prescribing list may prescribe oral cytotoxics for adult patients as a continuation of a patient s treatment. Unless details of the dosing regime and protocol are available in the notes or a patient hand-held record, the prescriber must contact the supervising team to clarify the regime and protocol for that individual patient and the plan must be documented in the medical notes before it is prescribed Cancer indications Even if there is a regime or protocol in the notes, where the patient is admitted on oral cytotoxics for cancer therapy the prescriber must always contact the specialist team before prescribing, as it may no longer be appropriate to continue. A doctor of ST3 or above or an approved non-medical prescriber must prescribe cytotoxic medicines for paediatric patients. 6.4 PRESCRIBING OF CYTOTOXIC CHEMOTHERAPY AS NEW THERAPY FOR ROUTINE TREATMENT OF NON-CANCER CONDITIONS Examples include the initiation of a cytotoxic e.g. oral methotrexate for the treatment of Rheumatoid arthritis by a specialist, IV cyclophosphamide for the treatment of SLE, topical or subconjunctival injections of 5FU. Any medical prescriber of ST3 level or above may prescribe new or continuation treatment of cytotoxic chemotherapy where the cytotoxic drug is established therapy in their specialist area. Medical prescribers below this grade may prescribe new or continuation treatment of cytotoxic chemotherapy if permitted to do so in accordance with local procedures. No specialist list of authorised prescribers is kept 8

9 6.5 PRESCRIBING OF CYTOTOXIC CHEMOTHERAPY BY A NON-CANCER SPECIALIST FOR A NEW/NOVEL INDICATION If a clinician, who is not an approved cytotoxic medicine prescriber, wishes a patient to receive a cytotoxic medicine, that clinician must seek advice from an approved NUH cytotoxic medicine prescriber, who will then prescribe the medicine if appropriate. The requesting clinician must provide a protocol or references to the approved NUH cytotoxic medicine prescriber to justify the prescription If the medicine is also a one-off request or for an unlicensed indication, then the DTC Chairman must also approve the request. The prescriber must follow the process for one-off requests; see the DTC website for further information. The prescriber must consult with a clinician who is familiar with cytotoxic medication if they have any reservations about prescribing in a particular instance. If the prescriber of the cytotoxic medicine is from a specialty other than the requesting team, the patient must be made explicitly aware that the prescribing doctor is an expert in the use of chemotherapeutic agents, but not in that specific indication. The prescriber only takes responsibility for the prescribing, the correct route of administration and monitoring of the chemotherapy agent. The overall responsibility for the treatment of the patient s care lies with the requesting clinician. The requesting clinician must determine if the cytotoxic medicine is producing the expected outcome and it is a joint decision between the requesting and authorised prescriber whether the treatment is to stop or continue. PRESCRIBING OF CYTOTOXICS FOR CONTINUATION ON ettos ON DISCHARGE Cancer indications Medical staff writing discharge prescriptions for patients who have been receiving oral cytotoxics for cancer indications, should write these on the etto. Supply will NOT usually be made against this by Pharmacy as the patient will usually have received an appropriate course length already, but it serves as a complete description of the patient s discharge medication for 9

10 the purposes of the discharging nurse and the GP. Supply will be made against approved prescriptions forms as described in Non-cancer indications Oral cytotoxics for non-cancer indications that are to be continued on discharge can be prescribed on the etto and supplies made against this if the patient does not have their own supply. See also Appendix 1 (methotrexate procedure). 6.7 NON-MEDICAL AND SUPPLEMENTARY PRESCRIBERS Non-medical prescribers are only permitted to prescribe cytotoxic medicines under independent prescribing provided these drugs have been listed on their NUH approved independent prescribing agreement, or under supplementary prescribing with clinical management plans. These both require approval at the Non-Medical Prescribing Committee TRAINING FOR PRESCRIBING Cytotoxic medication for cancer indications Prescribers may only be involved in the prescribing of anticancer medicines (cytotoxic chemotherapy, small molecule targeted treatments and monoclonal antibodies) for cancer indications if they have been specifically trained for this, using agreed training packages, and are assessed as competent. A register must be kept of approved doctors competent to prescribe oral and parenteral anti-cancer medicines and must be updated at each staff change. A named consultant within each specialty is responsible for keeping this register up to date. This includes prescribing of topical anti-cancer agents e.g. vesicular mitomycin, or other topical preparations Non cancer indications Individual departments may develop local procedures which determine what grade of staff may prescribe cytotoxic medication, and their Head of Department is responsible for keeping a register of competent medical staff. The head of any department where cytotoxics are prescribed is responsible for ensuring appropriate training is provided for their staff, and that records of that training are maintained. 6.9 CONSENT FOR CANCER CHEMOTHERAPY Written informed consent must always be obtained before the initial treatment course for the relevant treatment protocol, and 10

11 filed in the medical notes. Information about treatment protocols must be available to patients and carers. Treatment must always be discussed with patients and their relatives/carers to avoid confusion and anxiety. COMMUNICATION Information for patients All patients must be given verbal and written information about their chemotherapy and about possible side-effects. They must also be given a list of contact telephone numbers to call with any queries and if they are feeling unwell during a course of their treatment Information for Primary Care The medical team will provide written information for the GPs of patients undergoing chemotherapy regarding side-effects and possible complications of treatment, such as neutropenic sepsis, extravasation, nausea and vomiting PRESCRIPTION DOCUMENTATION Designated cytotoxic prescription charts, computer generated cytotoxic prescriptions or pre-printed cytotoxic prescription charts must be used where available. The prescriber must ensure that the most current version of the pre-printed prescription is used. Specialised charts are not necessary when prescribing oral cytotoxics for non-cancer use for in-patients, but may be developed and used if appropriate Electronic prescribing All cytotoxic chemotherapy regimes prescribed for oncology patients must be prescribed electronically on the Chemocare system. This includes all oral and parenteral therapy. Haematology regimes available on Chemocare, must be prescribed using the electronic system, in preference to preexisting pre-printed charts Specialist pre-printed charts Where a pre-printed specialist chart is available this must be used. All chemotherapy for haematology patients will be prescribed on specialist charts (for parenteral medication), or a generic chemotherapy chart (for oral medication) in cases where electronic prescribing is not used. 11

12 Oral cytotoxic chemotherapy (non-cancer chemotherapy) prescribed on the NUH in-patient chart Oral cytotoxic medicines for inpatients may be prescribed on the standard Trust inpatient prescription chart (General Medicine Prescription and Administration Record). A purple cytotoxic warning sticker must be attached to the prescription by the pharmacist, or the appropriate wording endorsed on the chart. The sticker alerts the nurses administering that gloves must be worn and two people are required to check the administration. Refer to the prescribing standards as stated in chapter CL/MM/006 of this Code of practice. In addition the prescription chart must also state, where appropriate: length of course or review date patient s weight patient s height patient s regimen being followed course number Oral cytotoxics prescribed for out-patients Oral cytotoxics for both cancer and non-cancer use must be prescribed ideally via Chemocare, or on a specialist prescription where available, or on the Trust out-patient prescription Parenteral cytotoxics for in-patients (non-cancer chemotherapy) All parenteral cytotoxic medicines for in-patients must be prescribed on a designated blue NUH cytotoxic prescription chart. There is also a generic blue NUH cytotoxic prescription chart for use in paediatrics, and specialist yellow charts for paediatric rheumatology and paediatric gastroenterology patients. Parenteral cytotoxic must not be prescribed on the standard Trust inpatient prescription chart Topical cytotoxics for cancer and non-cancer use Specialist charts must be used where available, e.g. specialist pre-printed cytotoxic prescribing charts must be used for prescribing mitomycin for bladder instillation and methotrexate for ectopic pregnancy NEW REGIMENS, DEVIATIONS FROM STANDARD 12

13 REGIMES, AND ONE-OFF PROTOCOLS Chemotherapy Strategy Group must approve all new chemotherapy protocols and new indications for existing cytotoxic medicines for use in the Trust, for cancer indications, in liaison with the East Midlands Chemotherapy Group. The NUH Research and Development committee must approve all clinical trials before use. The Drug and Therapeutics Committee must approve all requests for new cytotoxics and new indications for existing cytotoxic medicines within the Trust for non-cancer use. Variations in the chemotherapy regimen must be clearly endorsed on the prescription chart or documented via e- prescribing system and discussed with an appropriate pharmacist. The prescriber must document any changes in the required dose in the patient s notes or record. If the prescription has been written, it must not be amended but must be crossed through and completely re-written (as per section CL/MM/006 of this Medicines Code of Practice). If a pre-printed prescription has been used, the prescriber must re-prescribe the drugs on a new chart. If the drugs have been prescribed electronically on Chemocare, the patient s record must be changed electronically, and NOT on the printed version, in order to ensure that dose amendments are carried through to future cycles. Consult the East Midlands Cancer Network Policy for preventing regular deviation from approved Network chemotherapy treatment algorithms for one-off protocol process. Despite the cessation of the Network, this policy is still in effect TIMELINESS OF PRESCRIBING OF CYTOTOXIC CHEMOTHERAPY THAT REQUIRES MANUFACTURING Routine prescriptions should be prescribed and professionally screened two working sessions before treatment is due to start (See Appendix 3). If the final decision to prepare and administer the chemotherapy depends on the results of patient investigations, pharmacy must still be informed in advance of the intention to treat. Failure to prescribe planned chemotherapy in advance may lead to treatment delays. This does not apply to items manufactured for topical use in ophthalmology clinics as these are manufactured in batches in 13

14 advance SUPPLY OF CYTOTOXIC CHEMOTHERAPY Authorisation of the Pharmacist to professionally screen a cytotoxic prescription. The DOH report from 2009 states that All chemotherapy prescriptions should be professionally checked by a pharmacist who has undergone specialist training, demonstrated the appropriate competence, and is locally authorised or accredited for the task. A list of designated pharmacists should be kept in the pharmacy department. This apples to oral as well as parenteral therapy All new pharmacists must undergo appropriate training and demonstrate competency as part of their induction process. Any qualified pharmacist may professionally screen cytotoxic medication for conditions unrelated to cancer. Only pharmacists who have undergone specialist training and have passed a competency assessment may professionally screen cancer chemotherapy. They must follow SOPs at all times. Professional screening of oral cytotoxics by a pharmacist must be carried out to the same standard as injectable therapy Dispensing and manufacture Preparation of cytotoxic chemotherapy for parenteral use must be carried out by the pharmacy in dedicated cytotoxic production units. These cytotoxics must only be prepared and checked by pharmacy staff (following Pharmacy SOPS) that have undergone appropriate training and demonstrated competency. Preparation of cytotoxic chemotherapy for oral, topical or other routes, where the preparation is licensed and available readymade, must be carried out in designated areas in the dispensaries. If an oral cytotoxic medicine is required in a liquid formulation and an injection can be given orally, this must be prepared in the pharmacy production unit at either campus. If not, a special 14

15 preparation must be manufactured in the pharmacy non-sterile manufacturing unit on QMC campus. Bladder instillations that are provided as a closed system may be prepared on the ward or clinic TRANSPORT OF CYTOTOXIC CHEMOTHERAPY Reconstituted cytotoxics Cytotoxics prepared by the pharmacy cytotoxic production units must be supplied in chemotherapy transport bags Specific bags are available for vinca alkaloids and these should be used when appropriate. Staff transporting these items must be aware of what they are carrying and of the Trust s cytotoxic spillage policy. The items must be signed out from pharmacy when collected. QMC campus Cytotoxics are signed out of pharmacy, against the prescription chart, on collection by trained members of staff. On receipt on the ward, a cytotoxic log sheet must be completed to allow tracking of the medication and the medication stored in the designated locked area. If chemotherapy is to be given immediately, the ward or department log must still be completed. The nurse administering the chemotherapy must write used immediately on the sheet. City campus All reconstituted chemotherapy is delivered to the appropriate area by the cytotoxic lab staff who have awareness of handling chemotherapy. Any collections made by ward staff are logged by pharmacy staff, with staff name, date, time, patient name, and clinical area recorded Liquid oral or topical therapy (including eye and ENT preparations) QMC campus Cytotoxic liquids, and topical and subconjunctival eye preparations will be sealed in a bag by pharmacy staff. Staff transporting these items must be aware of what they are carrying and of the Trust s cytotoxic spillage policy. The items must be signed out by ward staff against the prescription chart when they 15

16 are collected Oral therapy (solid dosage form, i.e. tablets) Oral cytotoxic tablets will be placed in a designated purple printed cytotoxic bag for collection or delivery Intrathecal therapy See section of this chapter of the Code of Practice Returning of cytotoxic medicines to Pharmacy The transport requirements stated above also apply to returning unused chemotherapy back to the pharmacy department. Under no circumstances should cytotoxics be returned to pharmacy in ward tins, boxes or envopaks. For parenteral chemotherapy, the log sheet must be completed or documentation made on the relevant production worksheets when chemotherapy is returned to the pharmacy department. The ward must also affix a sticker to the returned chemotherapy stating whether it is a fridge item, when removed from the fridge and the reason for nonadministration. These stickers are provided by Cytolab to chemotherapy areas ADMINISTRATION OF CYTOTOXIC CHEMOTHERAPY The principles in section CL/MM/008 of this Medicines Code of Practice apply to staff administering cytotoxics. The person in charge of the ward or department is responsible for ensure that all staff involved in the handling of cytotoxic chemotherapy are aware of the relevant procedures. All staff involved with cytotoxics must familiarise themselves with these procedures and to make themselves aware of the hazards of exposure to cytotoxic drugs Spillage Medical and nursing staff must familiarise themselves with the procedure for spillage of cytotoxics. A spillage kit must be readily available in any clinical areas where cytotoxic bladder instillations and parenteral or liquid preparations of cytotoxics are to be administered. 16

17 Handling of waste and bodily fluids Waste must be disposed of in designated bags & bins in accordance with the relevant local policies and procedures. Bodily fluids and contaminated linen must be disposed of in accordance with relevant local policies and procedures Extravasation Extravasation of cytotoxic medication is an emergency and must be treated immediately. All clinical areas where parenteral cytotoxic administration takes place must have appropriate extravasation kits and a copy of the current East Midlands Cancer network extravasation policy. Despite the cessation of the network this policy is still in effect. Medical and nursing staff must familiarise themselves with the local policy and procedure, the use of the kits and the management of patients who have experienced extravasation of cytotoxic chemotherapy Administration of parenteral cytotoxic chemotherapy Administration via a parenteral route must only occur in designated areas of the Trust that are used regularly for this purpose and equipped to deal with any emergency that may arise from this treatment (see local procedures). This includes the availability of extravasation kits, spillage kits, protective masks, aprons and gloves and appropriate cytotoxic waste disposal facilities. See Appendix 2 for a list of authorised areas Exceptions to administration of parenteral chemotherapy on a designated ward Circumstances where chemotherapy may be administered on a non-designated ward - In exceptional circumstances, i.e. only when it is not possible to transfer a patient to a designated ward for medical reasons, parenteral chemotherapy may be administered to a patient who is not on a designated ward. - In these instances the following must occur: Consultant decision that chemotherapy cannot be delayed until patient can be transferred to a designated clinical area Discussion and agreement between pharmacy, 17

18 doctors and nurse in charge of non-designated ward. Administration of chemotherapy only by a nurse or doctor trained in administration of cytotoxics (requires liaison with oncology or haematology nursing team). Chemotherapy is stored on designated ward and taken to non-designated ward at time of administration only, by trained nurse or doctor. Cytotoxic cin bin, extravasation kit and cytotoxic spillage kit must be made available. Details of all the above must be documented including a risk assessment, and must be signed by the consultant and relevant pharmacist (oncology, haematology, production or senior pharmacist). An incident form must be completed These records will be held in pharmacy and monitored and reviewed annually by the NUH chemotherapy strategy group Authorisation of personnel to administer parenteral cytotoxic chemotherapy Parenteral cytotoxics must be administered by a practitioner who has received the necessary training and been assessed as being competent in the procedure for administration of cytotoxics. This may be a senior doctor, or a nurse. Whoever administers the cytotoxic must be second checked by a nurse following the process in section CL/MM/008 (Administration of medicines) of this Medicines Code of Practice. Any member of nursing staff who is unsure about any detail of the administration must not proceed, but must seek help and advice from a more senior and/or experienced colleague. Any ambiguity in the prescription must be discussed with the prescriber before administration takes place Normal working hours for administration Wherever possible all inpatient and outpatient intravenous chemotherapy administered to patients within the oncology and haematology specialties will be within normal working hours. These are defined as Monday to Friday 9am to 5pm i.e. when 18

19 the usual complement of trained medical and nursing staff are on duty. Where it is clinically necessary to initiate and administer intravenous chemotherapy to a patient urgently out of hours, i.e. emergency chemotherapy., exceptions to this policy are: Inpatients on oncology and haematology wards (Fraser, Gervis Pearson, Hogarth, Toghill and Fletcher) at City campus, and E38 and E39 at QMC campus receiving approved chemotherapy regimens consisting of several days of chemotherapy, which require prolonged, continuous infusions, repeated daily doses or planned treatment that may need to be administered during the night or at weekends. Ideally all treatment should be commenced during normal working hours Administration of intrathecal cytotoxic chemotherapy See section of this chapter of the Code of Practice Administration of oral cytotoxic chemotherapy Oral cytotoxics must be checked by two nurses who are aware of the hazards of administering oral cytotoxic preparations. Any concerns over a prescription must be checked with the prescriber. If there are still concerns the nurses must check with a pharmacist before any oral cytotoxic medicines are administered. A patient s own medication must be checked for its suitability for use by a pharmacist or pharmacy technician before it is administered to that patient Administration of bladder instillations Administration must occur in designated areas of the Trust (see Appendix 2). Cytotoxic bladder instillations must be administered by a senior doctor or nurse who have been trained and assessed as competent in the procedure for administration. Whoever administers the cytotoxic must be second checked by a competent registered practitioner. Any member of nursing staff 19

20 who is unsure about any detail of the administration must not proceed, but must seek help and advice from a more senior and/or experienced colleague. Any ambiguity in the prescription must be discussed with the prescriber before administration takes place Other routes of administration Eye subconjunctival and topical and laryngeal/pharyngeal topical cytotoxics may only be administered by eye/ ENT surgeons of ST3 and above who are competent in the procedure for administration of cytotoxic medicine by that route. The administration must be second checked by a competent registered practitioner. An exception to this is that a nurse assessed as competent can administer Mitomycin C eye drops to patients on a ward. The administration must be second checked by another registered competent practitioner STORAGE OF CYTOTOXIC CHEMOTHERAPY IN CLINICAL AREAS Some cytotoxics may be stored in the clinical area if the expiry allows. However, some drugs deteriorate rapidly after reconstitution, and so must be used as soon as possible after receipt on the ward/clinic. All preparations will have storage instructions on the pharmacy label. Storage conditions must be checked on receipt onto the ward. It is the responsibility of the ward staff to ensure that the prepared cytotoxics are correctly stored and used in the correct order. Parenteral cytotoxics for storage at room temperature must be locked in a designated cupboard. Parenteral cytotoxics to be refrigerated must be locked in a designated cytotoxics drugs refrigerator, where the temperature is in the range of 2 C - 8 C. Refrigerated products should be warmed to room temperature before they are administered to the patient. Oral and topical cytotoxics may be stored in the patient s drug locker, or in the normal medicines fridge if they 20

21 need to be stored at 2 C 8 C. Intrathecal cytotoxic chemotherapy is not stored outside of Pharmacy. It is used immediately in the clinical area or returned to Pharmacy. See of this chapter of the Code of Practice. Oral liquid chemotherapy that requires refrigeration may be stored in the purple printed cytotoxic bag from Pharmacy in the normal ward medicines fridge, if no separate designated cytotoxic fridge is available. Oral liquid chemotherapy that does not require refrigeration may be stored in the patient s bedside drug locker inside the purple printed pharmacy bag 6.18 OUT OF HOURS SUPPLY OF CYTOTOXIC CHEMOTHERAPY FROM PHARMACY Parenteral chemotherapy Parenteral chemotherapy will not routinely be manufactured by pharmacy outside of agreed pharmacy working hours for any patients, except in the cases of: Adult and paediatric patients with newly diagnosed Acute Myeloid Leukaemia (AML) or Acute Lymphoblastic Leukaemia (ALL) with a high white cell count who may be supplied with pre-filled syringes of intravenous daunorubicin or cyclophosphamide; see supporting procedure. If an infusion is spiked or has expired, or has been incorrectly stored, the nurse or doctor must contact the on-call pharmacist who will be able to advise on the correct course of action. See supporting procedure Provision of reconstituted cytotoxic preparations outside normal working hours Oral chemotherapy Oral chemotherapy may be supplied until 10pm when two pharmacists are available. After 10pm oral chemotherapy will not be supplied with the exception of single dose hydroxycarbamide pre-packs OTHER NON-CYTOTOXIC DRUGS THAT REQUIRE SPECIALIST HANDLING There are a few drugs that are not cytotoxics which require similar preparation and handling precautions to be taken. These 21

22 drugs include: Monoclonal antibodies: Specialist preprinted charts or electronic prescribing must be used for prescribing where available. The handling requirements of these products vary between drugs, and Pharmacy must be contacted for advice if the prescriber or nurse is unsure. Oral Immunomodulators (e.g. thalidomide and lenalidomide): These drugs are not cytotoxic agents, however due to the risks with handling these drugs, a cytotoxic sticker must be added when prescribing. Some drugs for the treatment of infections (e.g. IV ganciclovir, IV pentamidine): These drugs are always prepared in Pharmacy. If they are required out-of-hours contact the on-call pharmacist for advice 7.0 Training and Implementation 7.1 Training Staff involved in any part of the process of handling intrathecal chemotherapy must undertake the appropriate annual training (see6.2.1) 7.2 Implementation This is an established policy and implementation will take place via the induction and training arrangements already in place. 7.3 Resources No additional resources are required. 22

23 8.0 Trust Impact Assessments 8.1 Equality Impact Assessment An equality impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. 8.2 Environmental Impact Assessment An environmental impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. 8.3 Here For You Assessment A Here For You assessment has been undertaken on this document and has not indicated that any additional considerations are necessary. 23

24 9.0 Policy / Procedure Monitoring Matrix Minimum requirement to be monitored Responsible individual/ group/ committee Process for monitoring e.g. audit Frequency of monitoring Responsible individual/ group/ committee for review of results Responsible individual/ group/ committee for development of action plan Responsible individual/ group/ committee for monitoring of action plan Review of adherence to policy Local governance groups and Chemotherapy Strategy group Review of any Datix incidents, new legislation, new guidelines Annually Local governance groups and Chemotherapy Strategy group Local governance groups and Chemotherapy Strategy group Local governance groups and Chemotherapy Strategy group 24

25 10.0 Relevant Legislation, National Guidance and Associated NUH Documents 10.1 NUH Intrathecal policy National Guidance on Intrathecal chemotherapy from the DOH Best practice procedures for handling, administration and disposal of Mitomycin C and 5-Fluoruracil solutions in Eye and ENT Theatres, and Eye out-patient clinics East Midlands Cancer Network Extravasation policy Provision of reconstituted cytotoxic preparations outside normal pharmacy working hours Guidance on the safe handling of monoclonal antibody (MAB) products: NHS Pharmaceutical Quality Assurance Committee National Cancer Peer Review Programme. Manual for Cancer Services: Chemotherapy Measures, Version 1.0. April 2014 East Midlands Cancer Network Policy for preventing the regular deviation from approved network chemotherapy treatment algorithms. July

26 Appendix 1 Procedure for use of oral methotrexate for non-cancer conditions at NUH (adults and paediatric patients) Introduction It is classed as a Department of Health Never Event 1 to prescribe, supply or administer daily oral methotrexate to a patient for non-cancer treatment, irrespective of whether it causes harm. If this occurs the patient is subjected to potential harm and the Trust receives a financial penalty. The purpose of this procedure is to: outline the process and responsibilities of NUH staff (including prescribers, nurses and pharmacy staff) when prescribing, supplying, or administering oral methotrexate for non-cancer conditions to adult and paediatric patients to reduce the risk of a methotrexate Never Event to reduce the potential harm to a patient caused by methotrexate if prescribed or administered incorrectly This procedure is not a clinical guide as to whether methotrexate is appropriate for an individual patient and does not provide guidance on monitoring of patients whilst on methotrexate. In Nottinghamshire, only 2.5mg strength are dispensed by pharmacies, including NUH (except for paediatrics where 10mg strength may be used), as per the NPSA alert 2 Prescribing for in-patients and on discharge In line with Medicines Policy CL/MM/013 (cytotoxics), doctors must be ST3 or above to initiate oral methotrexate where it is established therapy in their specialist area, but any grade of medical staff may prescribe oral cytotoxics to adult patients for continuation of therapy. Non-medical prescribers may prescribe oral methotrexate only when it is on their approved prescribing list. Medical staff of ST3 or above must prescribe methotrexate for paediatric patients. Refer to CLMM013 for more information 3. Oral methotrexate is administered ONCE A WEEK. Exceptionally (rheumatology only), the weekly dose may be split into two doses. For all prescriptions of methotrexate, including initiation and continuation, the prescriber must: Prescribe as WEEKLY, state the day of the week for administration, and strike through on the treatment chart the days where treatment is not to be administered Ensure co-prescription of oral folic acid where indicated Ensure when drug charts are rewritten the above applies 26

27 Rewrite the prescription in full if any amendments to the prescription are required. Issue patient with patient-held methotrexate booklet if initiating, and update booklet if dose changed (and patient s booklet is available). Prescribers should check this booklet for details when performing medicines reconciliation. Methotrexate booklets should be purchased by individual directorates. Pharmacists will annotate prescription charts for methotrexate with the endorsement Caution cytotoxic, Wear gloves or handle by patient only. Two person check required for administration, or will attach a purple sticker containing this information. Refer to Pharmacy procedure 4. Prescribing for outpatients If initiating methotrexate, the prescriber should issue the patient with a patientheld methotrexate booklet. The prescriber must prescribe the dose required in milligrams. Pharmacy will only supply 2.5mg tablets. Paediatric prescriptions must state the tablets strength required. Methotrexate must not be prescribed as directed. Patient s own supplies of methotrexate brought into hospital Patient s own supplies of methotrexate (including those in a dosette or similar device) may not be used in hospital for inpatient administration unless the patient has been assessed is self-administering in accordance with Trust policy. Pharmacy will assess methotrexate tablets brought in as part of the medicines reconciliation process, and will confirm the dose and day of the week the tablets are taken. Pharmacy staff will store these in a separate purple printed bag with a printed sticker attached stating NOT TO BE USED FOR IN- PATIENT STAY. These supplies should be kept in the patient s medicine locker and not used, and will be returned to the patient if appropriate by Pharmacy staff when they are supplying medicines for discharge 4. Pharmacy Supply Pharmacy will supply all patients taking methotrexate with one dose at a time. The supply from Pharmacy will state the dose (in mg) and the dose in equivalent number of 2.5mg tablets. Where the patient does not have their own appropriately labelled supply at home or with them, up to two week s supply will be provided on discharge. Supplies received from pharmacy should be stored in the purple printed bag in which they are dispensed, until ready for administration 4. Administration Nurses must ensure that they: 27

28 Only administer the methotrexate tablets to the patient named on the dispensing label, and not to any other patient. Keep the methotrexate in the purple printed cytotoxic bag when it arrives on the ward, if supplies ordered from Pharmacy Do not use patient s own supply whilst in-patient, unless patient has been assessed and is self-administering in line with Trust policy. Pharmacy must first assess suitability of tablets for use Administer using a two person check, and wear gloves when handling (as with other cytotoxics- see CL/MM/013) Return any unused tablets to pharmacy immediately after single dose is administered. Also refer to NUH administration policy CL/MM/008. Reporting Errors on DATIX (all staff) If prescriptions are prescribed as WEEKLY but the non-administration days are not crossed through, this should be fedback to the prescriber at the earliest opportunity. Report on DATIX (prescribing error) If there are other errors or ambiguities, contact the prescriber at the earliest opportunity to amend the chart. Report on DATIX If prescription is prescribed as daily but an administration error has not occurred, nurse must not administer until prescription has been amended by the prescriber, and this should be documented in the patient notes. Contact the prescriber to amend the prescription. Report on DATIX (prescribing error). If methotrexate has been incorrectly administered on consecutive days, this must be escalated immediately to the on-call consultant for that specialty (because it is a never event and is regardless of harm to patient). Report on DATIX (administration/prescribing error). In addition the Trust Medication Safety Officer (MSO) and the Trust Clinical Risk Lead should be informed at the earliest opportunity. References 1. DH never events Inappropriate administration of daily methotrexate 2. NPSA patient safety alert 13 Improving compliance with oral methotrexate guidelines 28

29 3. CL/MM/013 NUH Medicines policy: Policy for the prescribing, administration and supply of cytotoxic chemotherapy for any indication, other drugs requiring specialist handling 4. NUH pharmacy procedure for screening, dispensing and supply of oral methotrexate for non-cancer use in adults an paediatrics 29

30 Appendix 2- Named wards and clinical areas authorised to administer parenteral chemotherapy at NUH In the event of wards moving to a different ward location, the new ward location is authorised to administer parenteral chemotherapy. QMC Campus Parenteral cytotoxic chemotherapy must only be routinely issued to the following clinical areas: - E17 - E38 day case - E39 - E40 - PICU - PHDU - D57 Day case - C32 Emergency gynaecology (IM methotrexate only) City Campus Parenteral cytotoxic chemotherapy must only be routinely issued to the following clinical areas: - Gervis Pearson Ward - Fraser Ward - Oncology Chemotherapy clinic - Oncology Research treatment area - Fletcher Ward - Toghill Ward - Haematology Day Case Unit - Hogarth Ward Specific parenteral cytotoxic chemotherapy may be issued to the following clinical areas: - Nightingale 2 Ward (ganciclovir, IV azathioprine only) - Bramley Ward (ganciclovir, IV cyclophosphamide and IV azathioprine only) - Carrell Ward (ganciclovir, IV cyclophosphamide and IV azathioprine only) - Urology Out-patient Department (mitomycin for bladder instillations only) - Urology Theatre, Theatre 20 (mitomycin for bladder instillations only) - Harvey 2 Ward (mitomycin for bladder instillations only) - Loxley Ward (mitomycin for bladder instillations only) 30

31 - Critical care 1-10 (HDU) &11-18 (ITU) (ganciclovir only) Some areas, such as Gillies ward, may receive patients following administration of cytotoxic chemotherapy and require spill kits in order to deal with any cytotoxic waste. See spillage procedure for list of wards that have a cytotoxic spillage kit. Ganciclovir and pentamidine are not true cytotoxics, but because of potential side effects, handling precautions for cytotoxics must be employed. These drugs may be issued to any ward. Nursing staff involved must be are aware of handling precautions (suitable gloves, apron, disposal in cytotoxic cin bin, aware of location of nearest spillage kit). If a request is received to send cytotoxic chemotherapy to a non-designated ward, the prescriber must be contacted and made aware of this policy. Arrangements may need to be made by the doctor to transfer the patient to a designated ward. If this is not possible for medical reasons refer to section refer to relevant pharmacist (oncology, haematology, production or senior pharmacist) who will follow the exceptional circumstances procedure 31

32 Appendix 3: Cut-off times for manufacture of Chemotherapy and Monoclonal antibodies in the pharmacy cytolab unit In order to ensure a safe and timely service, effective from 30 th June 2014, the following cut-off times apply: Time treatment is planned for: Cut off time for authorised prescription to reach screening pharmacists Cut off time for authorised and screened prescription to reach Cytolab Monday 8am-12pm Pilot of making chemotherapy in advance of bloods and Monday 12pm-5pm authorisation. To be delivered on Friday evening* Screened, unauthorised prescriptions to be received in Cytolab by 5pm Thursday (10am Friday for bortezomib only). Tuesday 8am-12pm Monday 10am Monday 12pm Tuesday 12pm-5pm Monday 10am Monday 12pm Wednesday 8am-12pm Monday 3pm Monday 5pm Wednesday 12pm-5pm Tuesday 10am Tuesday 12pm Thursday 8am-12pm Tuesday 3pm Tuesday 5pm Thursday 12pm-5pm Wednesday 10am Wednesday 12pm Friday 8am-12pm Wednesday 3pm Wednesday 5pm Friday 12pm-5pm Thursday 10am Thursday 12pm Saturday Thursday 3pm Thursday 5pm Sunday Thursday 3pm Thursday 5pm * excludes regimes containing any of the following drugs: Amsacrine Brentuximab Cidofovir Mitomycin C Romidepsin Arsenic trioxide Busulfan Dacarbazine Ofatumumab Thiotepa Azacitidine Carboplatin Liposomal Daunorubicin Pemetrexed Tocilizumab Bendamustine Carmustine Liposomal Doxorubicin Pentamidine Trabectedin Bevacizumab Cetuximab Melphalan Raltitrexed Vinorelbine In-patient chemotherapy Whenever possible in-patient chemotherapy should follow the above cut-off times. However the very latest Cytolab can receive a pharmacist screened prescription is 1pm for treatment to start that day, and a screened prescription request for emergency chemotherapy listed in the out of hours chemotherapy procedure will be accepted by Cytolab up to 4pm on the day of treatment. Any exclusion to these times will require the consultant to complete the necessary form to explain the clinical need for treatment to start that day. Otherwise treatment will be made the following working day. For patients who require emergency treatment, please contact the relevant Clinical pharmacist who will advise and liaise with Cytolab. 32

33 APPENDIX 4 Equality Impact Assessment (EQIA) Form (Please complete all sections) Q1. Date of Assessment: 17 th September 2014 Q2. For the policy and its implementation answer the questions a c below against each characteristic (if relevant consider breaking the policy or implementation down into areas) Protected Characteristic a) Using data and supporting information, what issues, needs or barriers could the protected characteristic groups experience? i.e. are there any known health inequality or access issues to consider? The area of policy or its implementation being assessed: b) What is already in place in the policy or its implementation to address any inequalities or barriers to access including under representation at clinics, screening Race and N/A N/A N/A Ethnicity Gender N/A N/A N/A Age N/A N/A N/A Religion N/A N/A N/A Disability N/A N/A N/A Sexuality N/A N/A N/A c) Please state any barriers that still need to be addressed and any proposed actions to eliminate inequality 33

34 Pregnancy and N/A N/A N/A Maternity Gender N/A N/A N/A Reassignment Marriage and N/A N/A N/A Civil Partnership Socio-Economic N/A N/A N/A Factors (i.e. living in a poorer neighbour hood / social deprivation) Area of service/strategy/function Q3. What consultation with protected characteristic groups inc. patient groups have you carried out? None Q4. What data or information did you use in support of this EQIA? none Q.5 As far as you are aware are there any Human Rights issues be taken into account such as arising from surveys, questionnaires, comments, concerns, complaints or compliments? N/A Q.6 What future actions needed to be undertaken to meet the needs and overcome barriers of the groups identified or to create confidence that the policy and its implementation is not discriminating against any groups What By Whom By When Resources required 34

35 Q7. Review date October

36 Environmental Impact Assessment Appendix 5 The purpose of an environmental impact assessment is to identify the environmental impact of policies, assess the significance of the consequences and, if required, reduce and mitigate the effect by either, a) amend the policy b) implement mitigating actions. Area of impact Waste and materials Soil/Land Water Air Environmental Risk/Impacts to consider Is the policy encouraging using more materials/supplies? Is the policy likely to increase the waste produced? Does the policy fail to utilise opportunities for introduction/replacement of materials that can be recycled? Is the policy likely to promote the use of substances dangerous to the land if released (e.g. lubricants, liquid chemicals) Does the policy fail to consider the need to provide adequate containment for these substances? (e.g. bunded containers, etc.) Is the policy likely to result in an increase of water usage? (estimate quantities) Is the policy likely to result in water being polluted? (e.g. dangerous chemicals being introduced in the water) Does the policy fail to include a mitigating procedure? (e.g. modify procedure to prevent water from being polluted; polluted water containment for adequate disposal) Is the policy likely to result in the introduction of procedures and equipment with resulting emissions to air? (e.g. use of a furnaces; combustion of fuels, emission or particles to the Action Taken (where necessary) No N/A No No N/A No No N/A No 36

37 Energy Nuisances atmosphere, etc.) Does the policy fail to include a procedure to mitigate the effects? Does the policy fail to require compliance with the limits of emission imposed by the relevant regulations? Does the policy result in an increase in energy consumption levels in the Trust? (estimate quantities) Would the policy result in the creation of nuisances such as noise or odour (for staff, patients, visitors, neighbours and other relevant stakeholders)? N/A N/A No no 37

38 Appendix 6 We Are Here For You Policy and Trust-wide Procedure Compliance Toolkit The We Are Here For You service standards have been developed together with more than 1,000 staff and patients. They can help us to be more consistent in what we do and say to help people to feel cared for, safe and confident in their treatment. The standards apply to how we behave not only with patients and visitors, but with all of our colleagues too. They apply to all of us, every day, in everything that we do. Therefore, their inclusion in Policies and Trust-wide Procedures is essential to embed them in our organization. Please rate each value from 1 3 (1 being not at all, 2 being affected and 3 being very affected) Value Score (1-3) 1. Polite and Respectful 1 Whatever our role we are polite, welcoming and positive in the face of adversity, and are always respectful of people s individuality, privacy and dignity. 2. Communicate and Listen 1 We take the time to listen, asking open questions, to hear what people say; and keep people informed of what s happening; providing smooth handovers. 3. Helpful and Kind 1 All of us keep our eyes open for (and don t avoid ) people who need help; we take ownership of delivering the help and can be relied on. 4. Vigilant (patients are safe) 1 Every one of us is vigilant across all aspects of safety, practices hand hygiene & demonstrates attention to detail for a clean and tidy environment everywhere. 5. On Stage (patients feel safe) 1 38

39 We imagine anywhere that patients could see or hear us as a stage. Whenever we are on stage we look and behave professionally, acting as an ambassador for the Trust, so patients, families and carers feel safe, and are never unduly worried. 6. Speak Up (patients stay safe) 1 We are confident to speak up if colleagues don t meet these standards, we are appreciative when they do, and are open to positive challenge by colleagues 7. Informative 1 We involve people as partners in their own care, helping them to be clear about their condition, choices, care plan and how they might feel. We answer their questions without jargon. We do the same when delivering services to colleagues. 8. Timely 1 We appreciate that other people s time is valuable, and offer a responsive service, to keep waiting to a minimum, with convenient appointments, helping patients get better quicker and spend only appropriate time in hospital. 9. Compassionate 1 We understand the important role that patients and family s feelings play in helping them feel better. We are considerate of patients pain, and compassionate, gentle and reassuring with patients and colleagues. 10. Accountable 1 Take responsibility for our own actions and results 11. Best Use of Time and Resources 1 Simplify processes and eliminate waste, while improving quality 12. Improve 1 Our best gets better. Working in teams to innovate and to solve patient frustrations TOTAL 12 39

40 APPENDIX 7 CERTIFICATION OF EMPLOYEE AWARENESS Document Title The Prescribing, Administration And Supply Of Cytotoxic Chemotherapy For Any Indication, And Other Drugs Requiring Specialist Handling Policy Version (number) 4 Version (date) 28 October 2014 I hereby certify that I have: Identified (by reference to the document control sheet of the above policy/ procedure) the staff groups within my area of responsibility to whom this policy / procedure applies. Made arrangements to ensure that such members of staff have the opportunity to be aware of the existence of this document and have the means to access, read and understand it. Signature Print name Date Directorate/ Department The manager completing this certification should retain it for audit and/or other purposes for a period of six years (even if subsequent versions of the document are implemented). The suggested level of certification is; Clinical directorates - general manager Non clinical directorates - deputy director or equivalent. The manager may, at their discretion, also require that subordinate levels of their directorate / department utilize this form in a similar way, but this would always be an additional (not replacement) action. 40