PROCEDURE REFERENCE NUMBER SABP/EXECUTIVE BOARD/0017/PROCEDURE15 PROCEDURE NAME MEDICINES PROCEDURE 15: METHOTREXATE

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1 PROCEDURE REFERENCE NUMBER SABP/EXECUTIVE BOARD/0017/PROCEDURE15 PROCEDURE NAME MEDICINES PROCEDURE 15: METHOTREXATE BRIEF OUTLINE OF THIS PROCEDURE This procedure sets out the requirements for prescribing, administering, monitoring and dispensing of methotrexate for indications other than cancer chemotherapy. Version Number 4.0 Approving Committee Policy Category Executive Lead Name of Author Executive Board Clinical Chief Medical Officer Medicines Optimisation Committee Date Approved 25 th January 2019 Date Issued 2 nd April 2019 Review Date 25 th January 2022 Target Audience All staff prescribing, administering and dispensing medication. All pharmacy staff. KEY PRINCIPLES ABOUT THIS PROCEDURE 1. Reduce risk associated with methotrexate prescribing and administration 2. Facilitate confident prescribing, administration and dispensing of methotrexate 3. Improve awareness of the risks associated with methotrexate This procedure has been reviewed and is compliant with the most up to date Code of Practice and NICE Guidelines Title of Code of Practice NPSA Patient safety alerts 03 & 13: Reducing the harm caused by oral methotrexate and improving compliance with oral methotrexate guidelines Equality Act 2010 NICE Reference Number(s)

2 VERSION CONTROL LIST Version Date Author Status Comment 1.0 November 2009 Fiona Lockwood live 1.1 July 2011 Simon Whitfield draft /09/11 Simon Whitfield 2.1 October 2014 Fiona Lockwood 2.2 November 2014 Fiona Lockwood Draft for October PAG Draft ready for Nov 14 PAG Draft amended 3.1 January 2019 Alison Marshall Draft 4.0 January 2019 Alison Marshall Approved Procedure formal review date to expire in November 11. Version 1.1 sent out for consultation. Reviewed but no changes necessary Summary of Changes since Version 3.0 Numbers Page Paragraph Appendix Original/New/Amendment/Deleted Statement New template used minor typographical changes. Page 2 of 7

3 Contents Page Section Page Version Control List 2 Summary of Changes 2 PROCEDURE SECTION 1.0 Roles and Responsibilities Procedure Statement Related Policies Glossary of Terms References Procedure Monitoring Table Equality Analysis 7 Page 3 of 7

4 PROCEDURE SECTION 1.0 ROLES AND RESPONSIBILITIES The overarching policy for this procedure is the Medicines Policy, to view the Executive roles and responsibilities please refer to this policy under section 6 on page Prescribers To prescribe methotrexate in accordance with the policy below to ensure the safe use of this medicine 1.2 Staff Administering Medication (The term nurse used in the procedure may also include other staff trained and authorised to administer medicines). To be aware of the risks associated with methotrexate use, and to ensure that administration is in accordance with the policy. 1.3 Pharmacists To promote the safe prescribing and administration of methotrexate and only to supply this medicine when it is safe and appropriate to do so. 2.0 PROCEDURE STATEMENT Oral methotrexate is a safe and effective medication if taken at the right dose and with appropriate monitoring. However, very occasionally problems with taking the medication can cause serious harm and even death. The Trust will implement the National Patient Safety Agency (NPSA) action points (as applicable to a mental health trust). 3.0 RELATED POLICIES: The Medicines Policy Page 4 of 7

5 4.0 GLOSSARY OF TERMS mg MHRA NSPA 5.0 REFERENCES Milligram Medicines and Healthcare Products Regulatory Agency National Patient Safety Agency NPSA Alert: Improving compliance with oral methotrexate guidelines (NPSA/2006/13) NPSA. Towards the safer use of methotrexate PROCEDURE 6.1 SAFE PRESCRIBING PRACTICE CHECKLIST For individuals with rheumatoid arthritis, the vast majority are prescribed methotrexate ONCE A WEEK, and if given any more frequently this medicine CAN BE FATAL The prescriber should ensure the individual has previously been given information on the risks and benefits of oral methotrexate, issued with a monitoring booklet, and monitoring tests conducted. Confirmation of the individual s understanding and consent should be sought All prescribers must avoid the use of as directed in prescribing; a specific dose must be applied to each prescription Healthcare professionals should be aware of individuals who attend with symptoms such as breathlessness, dry persistent cough, vomiting or diarrhoea, as these can be signs of oral methotrexate toxicity or intolerance Individuals receiving oral methotrexate could be admitted to any ward or receive outpatient treatment for co-existing conditions. Staff in all areas may therefore be involved in ensuring continuity of prescribing, and monitoring or administering oral methotrexate. Full medication reviews, conducted where possible by pharmacists, should be undertaken on admission and prescribing, monitoring and administration requirements should be recorded in the individual s notes It is the prescriber s responsibility to record the correct dosage and Page 5 of 7

6 frequency on the hospital drug administration chart, and to strike out the six days of the week when a dose must not be administered Handwritten prescriptions and discharge summary information must be complete, legible and include the form, strength, dose and directions in full. 6.2 SAFE DISPENSING PRACTICE CHECKLIST Ask to see the individual s monitoring booklet and check if any dose changes have been made since the last prescription issue Assess the manual dexterity of each individual to reduce the likelihood of them decanting the tablets into another container at home (Equality Act applies) The strength of tablet supplied to the individual must stay consistent to prevent any confusion about the number of tablets they need to take, and the individual s monitoring document and Patient Medication Record should be checked to confirm the previous supply Tell the individual their dose in terms of quantity of tablets and weekly frequency. Give the individual a monitoring booklet if they have not already got one Some individuals will be taking oral folic acid to alleviate the side effects of methotrexate. Show the individual how to differentiate between the oral methotrexate and folic acid packaging. If they take both medicines at the same time, they will need to know how to distinguish between them, given that both may be round yellow tablets of similar size Ensure that 2.5mg and 10mg oral methotrexate are visually distinguishable by shape, and that packaging contains the cautionary wording required by the MHRA The dispensing software program must include oral methotrexate alerts and prompts. 6.3 SAFE ADMINISTRATION PRACTICE CHECKLIST Check the identity of the individual against the pharmacy labels attached to Page 6 of 7

7 the medicine container. Check the individual s name, the medicine, the strength of tablet, the dose and the timing Ask the individual (if possible) to confirm that the medicine is required. This includes checking whether any new medications have been started since the last dose of methotrexate was administered. If it is not possible to obtain this information from the individual, consider asking their family or carer Record the medication given on the medication administration record at the time of administering it; a delay in recording it can result in one or more additional doses being given. 6.4 MONITORING REQUIREMENTS Full blood count and renal and liver function must be tested before starting treatment and repeated weekly until therapy stabilised; thereafter individuals should be monitored every 2-3 months All healthcare professionals should ensure that the monitoring requirements are being carried out as set out for each individual. 7.0 MONITORING TABLE The monitoring table for this procedure can be located in the Medicines Policy which is the overarching policy for this document. 8.0 EQUALITY ANALYSIS The equality analysis for this procedure can be located in the Medicines Policy which is the overarching policy for this document Page 7 of 7