Policy on Pharmacological Therapies Practice Guidance Note The use of Oral Anti-Cancer Medicines and Oral Methotrexate within - V03 V03 - Issued Issue 1 Dec 15 Planned review December 2018 PPT-PGN 09 Part of NTW(C)38- Pharmacological Therapies Author/Designation Martina Khundakar - Senior Clinical Pharmacist Teresa Barnes - Lead Clinical Pharmacist - Specialist Care Responsible Officer / Designation Timothy Donaldson, Trust Chief Pharmacist Section Contents Page No: 1 Introduction 1 2 Prescribing of Oral Anti-Cancer Medication 2 3 Administration of Oral Anti-Cancer Agents 3 4 Monitoring of Medication 3 5.1-5.3 Methotrexate 4 5.4 Inpatient Treatment of Patients Taking Methotrexate 4 5.5 Prescribing of Methotrexate 5 5.6 Administration of Oral Methotrexate in Hospitals 5 5.7 Symptoms Indicating Possible Toxicity 6 1 Introduction 1.1 The prescribing and administration of oral anti-cancer medicines and oral methotrexate presents a significant risk to patients within Northumberland, Tyne and Wear NHS Foundation Trust (the Trust/NTW). 1.2 Medication which is prescribed at the wrong dose or frequency can result in death or significant morbidity. As a result, it is essential that the prescribing of these medicines takes place under the supervision of an appropriate specialist. 1.3 Treatment with oral anti cancer agents and methotrexate may be necessary for the continuing care of patients with concomitant physical illness, however the prescribing of these agents represents a significant deviation from the expertise and experience of prescribers, pharmacists and nursing staff working within the Trust. 1
1.4 The list of oral anticancer medicines currently used can be accessed at: www.bnf.org 1.4.1 These medicines are prescribed primarily as anticancer agents but may be prescribed for the treatment of other physical illnesses. 1.4.2 Methotrexate may also be prescribed for the treatment of rheumatoid and psoriatic arthritis, psoriasis and for the treatment of severe Crohn s disease (unlicensed indication). 2 Prescribing of Oral Anti-Cancer Medication 2.1 Treatment with oral anti-cancer medicines and methotrexate must be initiated by an appropriate specialist and not a doctor employed by the Trust. 2.2 Oral anticancer medicines may be prescribed under the direction of a cancer specialist working outside of NTW, provided that they take responsibility for the review of the patient and are able to provide advice to both medical and nursing staff. 2.3 A copy of the patient s treatment plan must be made available to those who are involved in the prescribing, dispensing and administration of oral anticancer agents. 2.4 In the majority of patients, methotrexate is given ONCE WEEKLY ON A SPECIFIED DAY. If prescribed more frequently than this, the prescription (medicine chart) MUST be validated and signed by a clinical pharmacist before being administered to the patient. 2.5 Where patients are to be initiated on an oral anticancer agent within the Trust following steps must be taken to minimise the risks to the patient. The patient should be given the opportunity to ask any relevant questions of the specialist prescribing the medicine or from another specialist familiar with the treatment regime. The patient must have ready access to the Patient Information Leaflet for the prescribed medication. The patient should be aware of the risks associated with treatment and any signs and symptoms that they may need to be aware of during treatment which could be an indication of a problem. The dosage, form and frequency of the medicine must be documented and communicated to the team in writing before any treatment is provided. Where this is not provided this should be requested to prevent unnecessary delay in treatment. Changes in dosage, formulation or frequency must be communicated in writing before these are implemented. Specialists must inform patients directly of any changes to their medication giving opportunity for questions. 2
3 Administration of Oral Anti-Cancer Agents 3.1 The pharmacy department will label these medicines with a purple Caution this is a cytostatic or cytotoxic agent sticker to aid recognition of such items. 3.2 Nursing staff must check that all medication is prescribed at the appropriate dosage and frequency before administering to the patient. This should be done by checking the patient s notes for the documented treatment plan. 3.3 Copies of the treatment plan should be made available to the Pharmacy department supplying the medication as an additional safeguard. 3.4 If the patient and medicine are unfamiliar to the nurse administering the medication a secondary check should be made with another colleague who knows the treatment plan and the patient before administration. It should be considered good practice to have a second person check the medicine being administered to the patient 3.5 Nurses involved in the handling of oral anticancer agents must wear appropriate protective clothing in accordance with the instructions provided by the pharmacy department. 3.6 If the dose is anything other than ONCE WEEKLY then the chart MUST have been validated and signed by a clinical pharmacist BEFORE the dose can be given. 4 Monitoring of medication 4.1 Any necessary monitoring of treatment must be stipulated in the treatment plan provided by the specialist. 4.2 The Trust may support the necessary monitoring where possible through regular blood tests as stipulated by the specialist in the treatment plan and assessment of adverse effects. 4.3 Nursing and medical staff must be warned of any additional monitoring that may be necessary during treatment and be aware of signs and symptoms of toxicity. 4.4 These signs/symptoms must be communicated with the named nurse responsible for the patient and all staff involved in his/her care. 4.5 The specialist must be consulted where there are any matters of concern with regard to the patient s treatment and physical health. 3
5 Methotrexate 5.1 Overdose of methotrexate for non-cancer treatment is classed as a never event by NHS England. Never Events are serious incidents that are wholly preventable as guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers. Each Never Event type has the potential to cause serious patient harm or death. 5.2 The following safe practice checklist has been developed in response to the National Patient Safety Agency (NPSA) alert 03 (2004) updated as alert 13 (2006) Improving compliance with oral methotrexate guidelines issued to prevent incorrect dosing incidents. 5.3 There are many patients being treated with weekly subcutaneous injections of methotrexate for a variety of inflammatory conditions. Although not covered by the National Patient Safety Agency (NPSA) Safety Alert, it has been agreed that the above recommendations should be applied to these patients, as far as they are relevant. 5.4 Inpatient Treatment of Patients Taking Methotrexate 5.4.1 The following should have been completed by the specialist prescribing team (e.g. rheumatology, dermatology) at the point of prescribing. It is the responsibility of NTW staff to ensure that patients have been given access to this information. Information on the risks and benefits of oral (and subcutaneous) methotrexate should be given to the patient (or parent/carer) Confirmation that the patient understands and consent should be sought Baseline monitoring tests should be conducted The arrangements for monitoring and the monitoring schedule should be explained to the patient The patient should be issued with a patient held monitoring booklet and information on methotrexate 5.4.2 Inpatient staff should ensure that the prescribing, monitoring and administration of oral methotrexate are continued whilst the patient is an inpatient receiving treatment for co-morbid conditions. 5.4.3 Medicines reconciliation on admission to hospital must be conducted on admission to hospital (Please refer to the Trust s NTW(C)17 - Medicines Policy practice guidance note, UHM-PGN-02 - Prescribing Medicines. 5.4.4 The prescribing, monitoring and administration requirements for the methotrexate should be recorded in the patient s notes. 4
5.5 Prescribing of Methotrexate 5.5.1 The prescriber is responsible for recording the correct dosage and frequency on the hospital drug administration chart (Kardex). Days on which a dose is not to be administered must be struck out (see example below). 5.5.2 Prescriptions must state the dose of methotrexate and frequency of administration (usually weekly). 5.5.3 Handwritten prescriptions and discharge summary information must be complete, legible and include the dosage form and strength. It is hospital trust policy that the only strength of methotrexate tablet used in the hospital is 2.5mg. Letters to GPs and outpatient/discharge prescriptions should clearly indicate the dose in terms of 2.5 mg tablets e.g. a 15 mg dose should be prescribed as Methotrexate 2.5mg tablets, take SIX tablets ONCE Weekly or Methotrexate, SIX 2.5mg tablets ONCE Weekly. 5.5.4 The results of any patient monitoring and changes in dose must be entered into the patient s hand held record. 5.5.5 It is hospital trust policy that the only strength of methotrexate tablet used in the hospital is 2.5mg. Letters to GPs and outpatient/discharge prescriptions should clearly indicate the dose in terms of 2.5 mg tablets e.g. a 15 mg dose should be prescribed as Methotrexate 2.5mg tablets, take SIX tablets ONCE Weekly or Methotrexate, SIX 2.5mg tablets ONCE Weekly. 5.5.6 Ensure details of dose changes recommended by specialists are recorded in the patient s monitoring booklet. 5.5.7 In the majority of patients, methotrexate is given ONCE WEEKLY ON A SPECIFIED DAY. If prescribed more frequently than this, the prescription (medicine chart) MUST be validated and signed by a clinical pharmacist before being administered to the patient. 5.6 Administration of Oral Methotrexate in Hospitals 5.6.1 Follow the guidance detailed within the Trust s NTW(C)17 - Medicines Policy practice guidance note UHM-PGN-03 - Administration of Medicines. 5
5.6.2 In addition, ask the patient to confirm the following: That they are still taking methotrexate The dose of the medication How often they take the medicine and when they last took it. For conditions usually seen by this Trust methotrexate should be prescribed once weekly 5.6.3 Record the medication given on the prescription/administration chart (Kardex) at the time of administration. A delay in recording administration can result in one or more additional doses being given. If the dose is anything other than ONCE WEEKLY then the chart MUST have been validated and signed by a clinical pharmacist BEFORE the dose can be given. 5.7 Symptoms Indicating Possible Toxicity 5.7.1 Patients complaining of the following symptoms and taking methotrexate could have methotrexate toxicity or intolerance: Rash or oral ulceration Nausea and vomiting Diarrhoea Dry, persistent cough Breathlessness Any sign of infection, particularly sore throat Abnormal bruising 6