NPA

STANDARD OPERATING PROCEDURE

Supplying Oral Anti-CancerMedicine

GUIDANCE NOTES

SUPPLYING ORAL ANTI-CANCER MEDICINES

In January 2008 the National Patient Safety Agency (NPSA) issued a rapid response report: Risks of Incorrect Dosing of Oral Anti-cancer Medicines. The report was in response to reports of three deaths and 400 patient safety incidents concerning oral anti-cancer medicines between November 2003 and July 2007. These medicines are increasingly being used in the community – during 2006-2007 nearly 18 million doses were used in hospitals and 6 million doses used in the community and these figures are likely to increase. 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 anti-cancer medicines. The NPSA report recommendations should be implemented by 22nd July 2008.

The NPSA rapid response report includes guidance and recommendations that are relevant to community pharmacy. This resource aims to help you review your dispensing procedures and standard operating procedures (SOPs) to ensure that you are following this guidance when anti-cancer medicines are supplied in your pharmacy. You can use the accompanying template NPA SOP (Appendix 1) to write a separate SOP for the supply of anti-cancer medicines 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:

  • The prescribing, dispensing and administering of oral anti-cancer medicines should be carried out and monitored to the same standard as injected therapy.
  • All oral anti-cancer medicine should be initiated by a cancer specialist and prescribed according to a written protocol and treatment plan.
  • Patients prescribed oral anti-cancer medicines should be supplied with written information about their medicines from the hospital where their anti-cancer therapy is initiated.
  • This information should include:
  • Details of the intended oral anti-cancer regimen
  • Treatment plan
  • Arrangements for monitoring
  • Guidance on treatment of toxicity
  • Contact details for specialist advice including contact details for a local hospital pharmacist with experience of treating cancer

This information is designed to be shared with pharmacists and pharmacy staff to enable you to meet the NPSA guidance on dispensing these medicines.

RESOURCES AND FURTHER INFORMATION

NPSA

The full NPSA rapid response report and further supporting materials are available at

Standards for cancer therapy

Further information can be found on the standards for cancer therapy in England at

Further information can be found on the standards for cancer therapy in Wales at

NPA resources

NPA Sales

  • Prescription alert stickers – can be placed onto dispensed medicines, including oral anti-cancer medicines, 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.

Appendix 1

TEMPLATE STANDARD OPERATING PROCEDURE

Supplying oral anti-cancer medicines

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 anti-cancer medicines is carried out in a safe, efficient way which complies with the NPSA recommendations for the supply of oral anti-cancer medicines.

SCOPE

This procedure covers the supply of oral anti-cancer medicines 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 these medicines when they are prescribed for non-cancer indications, or hormonal or anti-hormonal medicines used for cancer treatment.

The following medicines are defined as anti-cancer medicines by the NPSA and are included in the scope of this SOP:

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bexarotene

busulfan

capecitabine chlorambucil cyclophosphamide estramustine

etoposide

fludarabine

hydroxycarbamide idarubicin

lomustine

melphalan mercaptopurine methotrexate

mitotane

procarbazine

tegafur/uracil

temozolomide tioguanine

treosulfan andvinorelbine

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In addition targeted therapies such as the kinase inhibitors: dasatinib, erlotinib,imatinib, sorafenib, and sunitinib are also included.

The SOP only covers the use of these medicines when they are being used to treat cancer. If the medicine is being used for non-cancer treatment, a risk assessment will be carried out and relevant parts of the process applied as appropriate.

Please see the NPA SOP for the supply of methotrexate (available to download from the NPA website) which covers the supply of methotrexate for non-cancer treatment e.g. for dermatology or rheumatology.

Hormonal or anti-hormonal drugs which are used for cancer treatment are not included in the scope.

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 a patient presents a prescription for a medicine listed above for the first time, refer to a member of the dispensary team.
  • A member of the dispensary team should tactfully check that the treatment has been initiated by a hospital cancer specialist. (Remember these drugs are sometimes used to treat other non-cancer conditions so be careful not to alarm the patient.)
  • If the prescription is presented by a representative you will need to protect patient confidentiality – you should not discuss the patient’s condition or treatment with the representative, relative or carer without the patient’s consent.
  • Ask the patient/representative whether they have a copy of the treatment plan.
  • Ask the patient’s/representative’s permission to review the treatment plan.
  • Clip this to the prescription before passing it onto the dispensary team.
  • If the patient does not have the treatment plan, 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 treatment plan is not presented, alert a member of the dispensary team.
  • Ask the patient whether they take any other medicines (prescribed, OTC medicines, supplements, vitamins or herbal products).

Additional steps when regular or repeat prescriptions are presented

  • Ask the patient if their dose has been changed recently or since their last supply was dispensed.
  • Ask the patient if they have any questions about their treatment or if they have noticed any side effects from their treatment.
  • Ask the patient if they have experienced any symptoms of infection such as sore throat. 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 therapy is noted in the PMR.
  • Check the treatment plan against the prescription to confirm that the prescribed dose is appropriate for the patient.
  • Check the dose on the prescription against the PMR record to see if there have been any changes and check that this has been confirmed against the treatment plan.
  • Check the patient’s PMR to see if there have been any changes to the patient’s other medication.
  • Anti-cancer medicines can interact with many other drugs 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.
  • If the prescription is for another medicine, assess whether it may have been prescribed to counteract a side effect of the oral anticancer medicine and whether it is appropriate.

Interventions and problem solving

  • If the patient’s representative does not have the treatment plan, 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 ensure he/she is aware of the interaction and that arrangements have been made for additional monitoring to be carried out if necessary.
  • Obtain specialist advice if necessary e.g. using the local contact details on the patient’s treatment plan.
  • If the patient is experiencing possible symptoms of toxicity or signs of an infection, contact the prescriber.

Assembly and labelling

  • Pregnant staff should not handle cytotoxic medicines.
  • Staff should wear protective clothing, including gloves, if cytotoxic medicines are handled or removed from their packaging.
  • Cytotoxic medicines should not be used in monitored dosage systems because of the increased risks associated with handling these medicines.

Accuracy checking

  • Make sure all prescriptions for anti-cancer medicines are double checked by another qualified member of staff.
  • Check that the correct strengths have been selected.

Transfer to patient

  • Check that the patient is aware of the required monitoring arrangements.
  • Find out what the patient already understands and remembers about their anticancer medicines.
  • Explain in clear and simple terms what the medicines are for and when the patient needs to take them.
  • Accurately answer any questions relating to the patient’s therapy at an appropriate pace and level within your level of competence.
  • Refer the patient to the sources of advice listed in their treatment plan if necessary.
  • Signpost the patient to information available on NHS cancer centre websites e.g. and
  • Ensure the patient is aware of the potential for their medicines 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 anticancer medicines.
  • Remind the patient that they should report all signs and symptoms of infection, including a sore throat, to their prescriber.
  • Offer compliance aids, such as reminder charts if appropriate, to help the patient to remember to take every dose prescribed.
  • Advise carers that they should avoid handling these medicines if possible.
  • Return the treatment plan to the patient

RESPONSIBILITY OF STAFF

Your SOP needs to specify who is responsible for dealing with all aspects of the supply of anti-cancer medicines. All staff involved in the supply of anti-cancer medicines should have received adequate training to ensure they have the necessary work competences. You may decide that some aspects of the supply of these medicines should only be carried out by the pharmacist.

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:

  • Patients presenting without treatment plans
  • Prescriptions presented by representatives
  • Prescriptions for other medicines (the GP prescribing system may not throw up interaction alerts if the oral anticancer treatment is prescribed by the hospital)

© National Pharmacy Association, April 2008

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