Document ref. no: Trust Policy and Procedure PP(16)234 Prescribing, Dispensing and Administration of Methotrexate Policy For use in: For use by: For use for: Document owner: Status: All Clinical Areas Excluding Paediatrics All Clinical Staff To ensure safe use of oral methotrexate Simon Whitworth, Chief Approved Contents Page 1. Introduction 1 2. Background 1 3. Scope 2 4. Prescriber information 2 5. Pharmacy Staff information 3 6. Nursing Staff information 4 7. Document Configuration 5 8. Appendix 1 Summary of information for Junior Doctors 6 Key messages Oral methotrexate MUST only be prescribed by Consultant Staff Oral methotrexate MUST only be prescribed once a week, the remaining six days of the week on the inpatient drug chart MUST be cancelled Patients receiving methotrexate MUST NOT be prescribed trimethoprim or co-trimoxazole (Septrin) preparations, the following wording MUST be added to the drug chart allergy box: Prescribed methotrexate - NOT to be prescribed trimethoprim or cotrimoxazole (Septrin) It is advised that methotrexate is not administered by nursing staff until the prescription has been authorised by the Pharmacy department If methotrexate is temporarily discontinued on admission to hospital, due to clinical reasons, the plan for restarting the methotrexate MUST be clearly stated on the drug chart and in the medical notes 1. Intoduction The purpose of this document is to ensure that all prescribing, dispensing and administration of oral methotrexate within West Suffolk NHS Foundation Trust is in accordance with NPSA Patient Safety Alerts 3 & 13 2. Background Oral methotrexate is routinely prescribed once weekly in rheumatology, gastroenterology and dermatology. Inadvertent daily prescribing of the weekly dose has lead nationally to a number of avoidable patient deaths. This policy does not cover the use of high dose methotrexate in oncology or haematology treatment regimes. Status: Approved Page 1 of 6
3 Scope This policy will apply to all areas of the Trust and all individuals employed by the Trust, including, contractors, voluntary workers, students, locum and agency staff and those holding honorary contracts. 4. Prescriber Information a. Methotrexate may only be prescribed by Consultant Staff b. Information on the risks and benefits of oral methotrexate should be given to the patient before treatment is initiated. Confirmation of the patient s understanding and consent should be sought, baseline tests conducted, monitoring schedule explained. If the treatment is initiated in the outpatient setting a patient-held monitoring booklet should be issued. c. Clear documented arrangements MUST be in place for all patients prescribed methotrexate to ensure that the following are clearly defined for the hospital prescriber, GP and patient: i. clarity of prescribing and monitoring responsibilities; ii. how often blood tests will be conducted and in which location; iii. which clinician will be responsible for receipt and review of the results; iv. who will communicate any necessary dosage changes to the patient and the GP; v. who will record test results on the patient-held monitoring booklet d. All prescribers must avoid the use of as directed in prescribing a specific dose must be applied to each prescription. Bear in mind that patients often understand their dose by the number of tablets they take rather than mg. The required quantity and frequency of dose should be regularly discussed with the patient. e. Repeat (installment) prescribing MUST NOT occur on Trust Outpatient or FP10HP prescription forms. The quantity supplied on the prescription must therefore be appropriate to the clinical needs of the patient but be supplied in one installment f. All staff involved in the care of patients prescribed methotrexate MUST be aware of patients who attend with symptoms such as breathlessness, dry persistent cough, vomiting or diarrhoea, as these can be signs of oral methotrexate toxicity or intolerance. g. It is advised that methotrexate is NOT administered against an inpatient prescription for methotrexate until the prescription has been authorised by a pharmacist, during normal working hours (see 5b-c). It is safer for a dose of methotrexate to be delayed or missed than for a dose to be inadvertently administered. It is recommended that patients own supplies of methotrexate are not used until the prescription has been authorised by a Status: Approved Page 2 of 6
The following steps MUST be followed i. All prescriptions must state: Once weekly treatment administer on..day only. ii. All patients prescribed methotrexate MUST have their prescription charts marked by a doctor, nurse or pharmacist: Prescribed methotrexate - NOT to be prescribed trimethoprim or co-trimoxazole (Septrin) in the Drug Reactions / Sensitivities / Allergies section of the drug chart h. If the clinical condition of a patient prescribed methotrexate deteriorates the continued need for methotrexate prescribing should be carefully considered and fully documented in patients notes. If treatment is discontinued this should be fully documented in the medical notes and on the inpatient drug chart and a clear plan documented for potential reintroduction of treatment. The methotrexate prescription should be cancelled on the prescription chart in such a way that it is clear that the patient was prescribed methotrexate but that it is not possible to administer any further doses unless the prescription is rewritten i. It is the prescriber s responsibility to record the correct dosage and frequency on the hospital drug administration chart, and to strike out the six days of the week when a dose must not be administered. j. Handwritten prescriptions and discharge summary information must be complete, legible and include the form, strength, dose and directions in full. 5. Pharmacy Staff Information a. On presentation of a methotrexate out-patient prescription Pharmacy staff will ask to see the patient s monitoring booklet and check if any dose changes have been made since the last prescription issue. b. All prescriptions screened by a pharmacist as appropriate for administration should be clearly marked Authorised and include the pharmacists initials and date and the statement Once weekly treatment administer on....day only. c. All patients prescribed methotrexate MUST have their inpatient prescription charts marked Prescribed methotrexate - NOT to be prescribed trimethoprim or cotrimoxazole (Septrin) in the drug allergy section of the drug chart if not completed by medical staff d. The strength of tablet supplied to the patient must stay consistent to prevent any confusion about the number of tablets they need to take, and the patient s monitoring document and Patient Medication Record should be checked to confirm the previous supply. The West Suffolk NHS Foundation Trust routinely uses only 2.5mg tablets, other than for paediatric patients being treated under specific shared care oncology regimes e. Patients will be informed of their dose in terms of milligrams and the quantity of tablets and weekly frequency. The patient will be given a monitoring booklet if they have not already got one. Status: Approved Page 3 of 6
f. If the patient is prescribed methotrexate and folic acid tablets it is essential that the patient is shown 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. g. Pharmacy staff must be aware of patients who attend with symptoms such as breathlessness, dry persistent cough, vomiting or diarrhoea, as these can be signs of oral methotrexate toxicity or intolerance. Patients reporting these symptoms must be referred back to the prescriber. It is good practice to record of any overthe-counter items supplied to the patient on their out patient prescription form or in their methotrexate treatment booklet. 6. Nursing staff information a. Check the patient s wristband against the medication administration record and the pharmacy labels attached to the medicine s container. Check the patient s name, the medicine, the strength of tablet, the dose and the timing. b. Check that the methotrexate prescription has been marked as authorised by a pharmacist. If this is not the case, withhold the dose and refer to the pharmacy department during normal working hours c. If the prescription is authorised, ask the patient to confirm that the medicine is required. d. Nursing staff must be aware of patients who report symptoms such as breathlessness, dry persistent cough, vomiting or diarrhoea, as these can be signs of oral methotrexate toxicity or intolerance. Patients reporting these symptoms must be referred back to the prescriber. e. 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. f. DO NOT administer trimethoprim or co-trimoxazole (Septrin) to patients if methotrexate is prescribed Status: Approved Page 4 of 6
Appendix 1 Summary of Methotrexate prescribing information for Medical Staff Treatment initiation a. Information on the risks and benefits of oral methotrexate should be given to the patient before treatment is initiated. Confirmation of the patient s understanding and consent should be sought, baseline tests conducted, monitoring schedule explained. If the treatment is initiated in the outpatient setting a patient-held monitoring booklet should be issued. a. Clear documented arrangements MUST be in place for all patients prescribed methotrexate to ensure that the following are clearly defined for the hospital prescriber, GP and patient: i. Clarity of prescribing and monitoring responsibilities; ii. How often blood tests will be conducted and in which location; iii. Which clinician will be responsible for receipt and review of the results; iv. Who will communicate any necessary dosage changes to the patient and the GP; v. Who will record test results on the patient-held monitoring booklet Prescribing a. Methotrexate may only be prescribed by Consultant Staff b. Junior medical staff may write methotrexate in the drug section of a drug chart, to act as a reminder for the next consultant ward round. This however must not be signed, dated or state a dose. This information will be added by Consultant staff only. c. All prescribers must avoid the use of as directed in prescribing a specific dose must be applied to each prescription. Bear in mind that patients often understand their dose by the number of tablets they take rather than mg. The required quantity and frequency of dose should be regularly discussed with the patient. d. The West Suffolk Hospital routinely uses only methotrexate 2.5mg tablets for adult patients e. All prescriptions must state: Once weekly treatment administer on..day only. f. It is the prescriber s responsibility to record the correct dosage and frequency on the hospital drug administration chart, and to strike out the six days of the week when a dose must not be administered. g. All patients prescribed methotrexate MUST have their prescription charts marked: Prescribed methotrexate - NOT to be prescribed trimethoprim or co-trimoxazole (Septrin) in the Drug Reaction / Sensitivities / Allergies section of the drug chart. h. All staff involved in the care of patients prescribed methotrexate MUST be aware of patients who attend with symptoms such as breathlessness, dry persistent cough, vomiting or diarrhoea, as these can be signs of oral methotrexate toxicity or intolerance. i. It is advised that methotrexate is NOT administered against an inpatient prescription for methotrexate until the prescription has been authorised by a pharmacist, during normal working hours. It is safer for a dose of methotrexate to be delayed or missed than for a dose to be inadvertently administered j. If the clinical condition of a patient prescribed methotrexate deteriorates the continued need for methotrexate prescribing should be carefully considered and fully documented in patients notes. If treatment is discontinued this should be fully documented in the medical notes and on the prescription chart and a clear plan documented for potential reintroduction of treatment. The methotrexate prescription should be cancelled on the prescription chart in such a way that it is clear that the patient was prescribed methotrexate but that it is not possible to administer any further doses unless the prescription is rewritten k. Handwritten prescriptions and discharge summary information must be complete, legible and include the form, strength, dose and directions in full. Status: Approved Page 5 of 6
Document Configuration Author(s): Simon Whitworth, Chief Other contributors: Approvals and endorsements: Drugs and Therapeutics Committee (Review 6.1.16) Drugs and Therapeutics Committee (Review 5.2.14) Drugs and Therapeutics Committee (Review 11.1.12) Drugs and Therapeutics Committee (Review 27.1.10) Operations Group (18.2.08) Medical Staff Committee (11.3.08) Consultation: Nursing directorate Pharmacy department Operations group Drugs and Therapeutics Committee Medical Staff Committee Issue no: 5 File name: H:\Personal\Simon\Policies\Methotrexate\Review Clinical Guideline Jan 2014.doc Supercedes: PP(16)234 Equality Assessed Yes Implementation Via Trust Policy site and inclusion in training programmes Monitoring: (give brief details how this As part of the associated NPSA required audit will be done) programme Other relevant policies/documents & Patient Safety Alert 13, Improving compliance with oral references: methotrexate guidelines, National Patient Safety Agency June 2006 Additional Information: Status: Approved Page 6 of 6