Supplying Oral Methotrexate

NPA

STANDARD OPERATING PROCEDURE

GUIDANCE NOTES

SUPPLYING ORAL METHOTREXATE

In 2006 the National Patient Safety Agency (NPSA) issued a patient safety alert on oral methotrexate therapy: NPSA Alert 13 – Improving Compliance with Oral Methotrexate Guidelines. This alert was originally issued in 2004 but the advice was updated and reissued as the NPSA continued to receive high numbers of reports of patient safety incidents, some of which were fatal, involving methotrexate. The NPSA guidance is designed to help NHS organisations, including community pharmacies, in England and Wales to take steps to minimise the risks associated with oral methotrexate therapy. The NPSA alert should have been implemented by 31 January 2007.

The NPSA patient safety alert includes guidance and recommendations that are relevant to community pharmacy. This resource aims to help you review your dispensing procedures and prepare a written standard operating procedure (SOP) to ensure that you are following the guidance when methotrexate is supplied in your pharmacy. You can use the model NPA SOP (Appendix 1) for the supply of oral methotrexate to write a separate SOP for the supply of methotrexate or you can incorporate the guidance into your existing dispensing SOPs.

The NPSA patient safety alert includes the following recommendations of relevance to community pharmacy:

· All patients prescribed oral methotrexate should receive appropriate information before and during treatment.

· Pharmacy staff should ask to see the patient’s monitoring booklet and should check to see if there have been any dose changes since the last prescription.

· Patients should be given a monitoring booklet if they have not already got one.

· The strength of the tablet supplied should stay the same to prevent any confusion about the number of tablets the patient needs to take.

· Prescribers should avoid “as directed” prescriptions for methotrexate so the container should always be labelled with a specific dose.

· The dosage instructions on dispensing labels should be expressed in terms of the number of tablets to be taken rather than in mg. In most cases the dose will be weekly rather than daily.

· When ordering methotrexate tablets ensure that the different strength tablets are easily distinguishable by shape and that the packaging contains appropriate warnings.

· Patients who are also taking folic acid should be shown how to differentiate between the two medicines.

· Patients presenting with symptoms such as breathlessness, dry persistent cough, vomiting or diarrhoea should be referred to their doctor.

· It is good practice to maintain a record of any OTC items supplied to the patient.

Packaging

The NPSA is working with the pharmaceutical industry on new packaging for methotrexate tablets. The new packaging will be designed for patients with reduced manual dexterity and will have new labelling and safety information. It is also likely that the packaging will contain reduced quantities of tablets which will be equivalent to one, two or three month’s treatment depending on dose.

Until the new packaging is available the NPSA advises that the patient’s needs should be assessed to see if patients with reduced manual dexterity require larger containers or ribbed easy to open lids (contact NPA Information for details of suppliers of winged caps). You could do this as part of a medicines use review (MUR) for the patient if appropriate.

RESOURCES AND FURTHER INFORMATION

NPSA

The full patient safety alert and further supporting materials are available at -

http://www.npsa.nhs.uk/patientsafety/alerts-and-directives/alerts/oral-methotrexate/

NPA resources

The following items can be obtained from NPA Sales on 01727 800401 -

· Prescription alert stickers – can be placed onto dispensed medicines, including methotrexate, to alert the pharmacist that counselling is required.

· Check strength, check name, check dose shelf edge stickers.

· Medicine care cards – can be used to provide further information and/or reminders to help patients remember to take their medicines correctly.

· Disability Discrimination Assessment record book – to record DDA assessments and action taken.

Appendix 1

MODEL STANDARD OPERATING PROCEDURE

Supplying oral methotrexate

The template standard operating procedure (SOP) below should be read in conjunction with the accompanying guidance notes and should be tailored to meet your individual circumstances.

PURPOSE

To ensure the supply of oral methotrexate is carried out in a safe, efficient way which complies with the NPSA recommendations on the supply of oral methotrexate.

SCOPE

This procedure covers the supply of oral methotrexate by the pharmacy including prescription receipt, pharmaceutical assessment, interventions and problem solving, assembly and labelling, accuracy checking and transfer to patient. It does not include the supply of methotrexate injections.

PROCESS/PROCEDURE

Typical steps may include some of the following (the order and the way in which you do these in your pharmacy may vary from the list below so choose those most suited to your own practice).

Prescription receipt

· If the patient presents a prescription for methotrexate for the first time check whether the patient has had methotrexate before (e.g. from the hospital or from another pharmacy)

· Ask the patient whether they have received a pre-treatment information leaflet.

· Ask the patient whether they have received a patient held monitoring booklet.

· If the patient has not received a copy of the pre treatment information leaflet or patient held monitoring booklet, further copies can be obtained from …………………………….(Check with your PCO how these are distributed in your area).

· Ask the patient or representative presenting the prescription whether the pharmacist can see a copy of the patient’s monitoring booklet.

· Clip this to the prescription before passing it onto the dispensary team.

· If the patient or representative does not have the monitoring booklet, remind them that it is very important that the pharmacist sees it on each occasion and ask them to bring it next time.

· If the monitoring booklet is not presented, alert the dispensary team.

· Ask the patient whether they take any other medicines (prescribed, OTC, supplements, vitamins, herbal products etc).

· Pass any relevant information obtained to the dispensary team.

Additional steps when regular or repeat prescriptions are presented

· Ask the patient if the dose has been changed recently or since their last supply was dispensed.

· Ask the patient if they have any questions about their therapy or if they have noticed any side effects from the methotrexate.

· Ask the patient if they have experienced any symptoms such as breathlessness, dry persistent cough, vomiting or diarrhoea as these can be signs of methotrexate toxicity or intolerance. Refer any patients with these symptoms to the pharmacist.

· Pass any relevant information obtained to the dispensary team.

Pharmaceutical assessment

· Where possible, try to ensure that the indication for methotrexate therapy is noted in the PMR.

· Check the monitoring booklet and any information obtained by prescription receipt staff for any dose changes.

· Check the dose on the prescription against the PMR record to see if there have been any changes.

· Check the patient’s PMR to see if there have been any changes to the patient’s other medication.

· Several drugs interact with methotrexate so check to see if there has been a new drug added, a dose change to another medicine or whether an interacting drug has been discontinued.

Interventions and problem solving

· If the patient’s representative does not have the monitoring booklet, contact the patient/carer by telephone if possible to obtain the necessary information.

· If the patient is prescribed other potentially interacting medicines or if an interacting medicine is discontinued, contact the prescriber to make sure he/she is aware of the interaction and that arrangements have been made for additional tests to be carried out if necessary.

· If the patient is experiencing possible symptoms of toxicity, contact the prescriber.

Assembly and labelling

· Check the PMR records to find out which strength of tablets the patient takes (2.5mg or 10mg) as this should be consistent each time methotrexate is dispensed.

· Produce a label which has instructions for the number of tablets to be taken rather than the number of milligrams to be taken.

· Never use ‘as directed’ on the label.

· Make sure the instructions advise weekly and not daily dosage.

· If the patient is to have a mixture of 10mg and 2.5mg tablets, where possible, make sure the tablets look different and have different packaging.

· If dispensing a mixture of 2.5mg and 10mg tablets, double check that the labels have not been transposed.

Accuracy checking

· Make sure all prescriptions for methotrexate are double checked by another qualified member of staff.

· Check that the correct strength has been selected.

· Check that the label states weekly dosage.

· Check that the instructions are for number of tablets, not milligrams.

Transfer to patient

· Find out what the patient already understands and remembers about their methotrexate therapy.

· Advise the patient of their dose in terms of number of tablets and weekly frequency.

· If the patient has also been prescribed folic acid, demonstrate the difference between the oral methotrexate and folic acid, especially if the packaging is similar.

· Accurately answer any questions relating to the patient’s therapy at an appropriate pace and level.

· Explain in clear and simple terms what the medicines are for and when the patient needs to take them.

· Ensure the patient is aware of the potential for methotrexate to interact with other medicines, including those bought over the counter, and that they understand the need to consult with a pharmacist or the prescriber before taking other medicines.

· Where possible, record on the PMR any OTC medicines supplied to patients taking methotrexate.

· Remind the patient that they should report all signs and symptoms of infection, including a sore throat, to their GP.

· Offer compliance aids, such as reminder charts if appropriate, to help the patient to remember to take every dose prescribed.

· Assess the patient’s manual dexterity to see if they require larger containers or ribbed easy to open lids.

· Assess the patient’s visual status to find out whether they can read label instructions.

· Give the patient a leaflet if appropriate.

· Return the monitoring booklet to the patient

RESPONSIBILITY OF STAFF

Your SOP needs to specify who is responsible for dealing with all aspects of the supply of oral methotrexate from prescription receipt through to transfer to patient. All staff involved in the supply of methotrexate should have received adequate training to ensure they have the necessary work competences.

KNOWN RISKS

This section should contain a description of anything you are aware of that can make the procedure more risky than usual. These are circumstances that you know can increase the likelihood of things going wrong and where you believe extra care and attention should be paid. For example, known risks might include:

· Prescriptions presented without monitoring booklets

· Prescriptions without a dose

· Prescriptions presented by representatives

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