West Suffolk Clinical Commissioning Group (WSCCG) Safety audit for methotrexate prescribing for patients in primary care

Transcription

1 West Suffolk Clinical Commissioning Group (WSCCG) Safety audit for methotrexate prescribing for patients in primary care Year Safety 100% of patients prescribed oral methotrexate should have their treatment recommendation reviewed to ensure appropriate monitoring is taking place in order to reduce the risk of harm Background Oral methotrexate is a well-established and effective medicine that can help treat many conditions. Over 50,000 patients are given oral methotrexate each year and most people receiving it are greatly helped. However, harm can be caused to patients if methotrexate is not taken correctly. The National Patient Safety Agency (NPSA) issued an alert in June highlighting the potential hazards of methotrexate. Methotrexate is a safe and effective medication if taken at the right dose and with appropriate monitoring. Aim To identify patients currently taking oral methotrexate and ensure that clear dose instructions are present To review patients currently prescribed oral methotrexate and ensure all monitoring is taking place and up to date Inclusion Criteria All patients prescribed oral methotrexate 2.5mg tablets and methotrexate 10mg tablets Monitoring Requirements 2 Full blood count (FBC), liver function tests (LFTs) and renal function tests (U&Es) should be carried out before treatment with methotrexate commences and repeated every 1-2 weeks until therapy stabilised, thereafter patients should be monitored every two to three months Dose Instructions 2 All doses for oral methotrexate must be as a single weekly dose To avoid potential dosing errors, it is recommended that; only one strength of methotrexate is prescribed and dispensed (usually 2.5mg tablets) the patient is carefully advised of the dose and frequency and interacting medications Prepared by: Leanne Bartholomew, Senior Medicines Management Technician Version 1.0 December 2013

2 Additional considerations: In order to successfully complete this audit, practices must also demonstrate compliance with NPSA actions 1 : Information given to patient on risks and benefits of oral methotrexate. Confirmation of patient s understanding and possession of patient-held methotrexate monitoring booklet Practice prescribing software is updated with the latest version, including methotrexate alerts and prompts Practice repeat prescribing protocol includes instruction to separate methotrexate prescriptions from surgery repeats pile prior to signing by GP (to alert prescriber to high-risk drug) Responsibilities The WSCCG technician and/or pharmacist are responsible for: o obtaining authorisation from the GP to perform the safety audit; both parties should sign the agreement on the data collection sheet. All work should be carried out as per the WSCCG Generic Technicians & Pharmacists Protocol for working in practice o carrying out the audit procedure in the GP practice (e.g. performing the search to identify patients being prescribed oral methotrexate, highlighting relevant patient information and risk factors to the GP, completing the audit worksheet, submitting the worksheet to GP action, making agreed entries in patient records, and adding notes to consultation records, when necessary) o communicating changes or monitoring requests to the patient (e.g. via letter). o advising local community pharmacies/practice dispensaries of the audit work to be undertaken, and provide them with any supporting information which may be necessary to answer patient queries The GP is responsible for: o authorising the safety audit to be carried out in practice o reviewing the audit worksheet submitted by the technician/pharmacist and agreeing which patients need to be recalled for monitoring o completing and returning the audit worksheet to the technician/pharmacist within an agreed timeframe o authorising the communication of changes/review invitations to the patient (e.g. the approval of the letter sent to patients) o ensuring that patients are followed-up and any additional monitoring is undertaken Procedure 1. A computer search should be run to identify all patients currently prescribed oral methotrexate using the following search terms 2 (where relevant): Methotrexate 2.5mg tablets, Matrex 2.5mg tablets, methotrexate 10mg tablets 2. Patient details identified from the search should be recorded on the audit worksheet, including ID number, name, age, and GP. 3. Drug details identified from the search should be recorded on the data collection worksheet, including the indication, dose, and quantity prescribed. 4. Consider recommending monitoring actions where details are out of recommended time frame or range (see appendix 1). 2

3 5. Complete the data collection sheet provided for each patient and then forward to the relevant GP(s) for review; once the worksheet is returned, make the agreed actions on the patient s medical record as instructed by the GP. 6. Patients due monitoring should be informed by a letter on practice-headed paper and signed by the GP/Practice/Technician/Pharmacist (as appropriate). GPs must ensure that patients who are invited for a blood test or review receive appropriate follow-up. References 1. Patient Safety Alert, National Patient Safety Agency, June 2006 (accessed online via 2. British National Formulary, 66th Edition, September Ed. Ryan R. BMJ Group and Pharmaceutical Press (accessed online via 3

4 Appendix 1 Normal test range values Normal test ranges: Test requested Test contains Normal range Full Blood Count Hb Male g/dl (FBC) (Haemoglobin) Female g/dl MCV 77-95Fl (Mean Cell Value) WBC (White Blood Count) x 10 9 /l Liver Function Tests (LFTs) Urea and electrolytes (U&Es) RBC x 10 9 /l (Red Blood Cell Count) Platelets x 10 9 /l Neutrophils x 10 9 /l Lymphocytes x 10 9 /l ALT <36units/l (Alanine aminotransferase level) Alk phos units/l (Alkaline phosphatase) Bilirubin level 5 17umol/l Protein 60 80g/L Albumin 35 50g/L Urea mmol/L Creatinine umol/L Sodium mmol/L Potassium umol/L N.B Test ranges are taken from clinical system ranges and these may vary slightly. If test results have been looked at by a GP and states normal this is acceptable Signs of toxicity or intolerance include: Sickness Diarrhoea/stomach upset Mouth ulcers/sore throat/sore mouth Skin rashes Infections Bleeding Bruising Jaundice Itching Breathlessness Dry persistent cough 4

5 Monthly Quantity Oral methotrexate data collection sheet Practice Technician/Pharmacist Date GP authorisation Date Patient Methotrexate Interacting medicines? (If yes, please specify) ID Name Age GP Drug & strength Indication Dose Signs of toxicity or intolerance? (If yes, please specify) Date of most recent monitoring test All test results within normal range? FBC LFTs U&Es Yes No Actions for GP* Significant Interacting drugs (as listed in the BNF) Nitrous oxide NSAIDs (ibuprofen, aspirin, diclofenac, indomethacin, ketoprofen, meloxicam, naproxen) Antibacterials (neomycin, ciprofloxacin, sulfamethaxazole, doxycycline, sulfonamides, penicillins, trimethoprim) Clozapine Ciclosporin Cisplatin Leflunomide Probenecid Acitretin *Actions which must be flagged for the GP to address: Methotrexate is not prescribed as 2.5mg tablets only The patient is taking interacting medicines All monitoring is not being carried out every 2-3 months The methotrexate dose is not weekly GP to confirm with patient that they have a methotrexate booklet and that it is up to date when patient next seen. Record in patient notes. 5

6 Oral methotrexate data collection sheet Practice Technician/Pharmacist Date GP authorisation Date Please tick correct option(s) 1. What computer software system do you use in your practice? EMIS LV EMIS Web SystmOne Other (Please specify).. 2. When prescribing methotrexate, does your computer system bring up any alerts about methotrexate risks and safety? Yes No 3. Are methotrexate prescriptions separated from the rest of the surgery repeats pile prior to signing by GP (to alert prescriber to high-risk drug)? Yes No 4. Does the practice repeat prescribing protocol include the correct instructions about separating out methotrexate prescriptions? Yes No If any answer to questions 2, 3 or 4 is NO highlight to GP and refer to practice manager 6