Non-Formulary Medicines

  • When initiating treatment, prescribers are requested to prescribe medicines included in the Formulary (link). However, it is accepted that, when all alternatives have been tried and failed or not suitable, a non-formulary medicine may be needed. In such circumstances the form below must be completed (can only be completed by a CONSULTANT or SpR. Expensive medicines may need Directorate approval.
  • For unlicensed medicines, part 2 needs to be completed.
  • This form needs to be completed for EACH PATIENT. If usage extends to MORE THAN ONE PATIENT, then a formal submission to the Area Prescribing Committee WILL BE necessary.
  • ANY STOCK, PURCHASED FOR THIS APPLICATION WILL BE CHARGED TO THE WARD OR DIRECTORATE CONCERNED.
  • Prescribing data for non-formulary drugs will be sent to the STS Area Prescribing Committee who may review and ask for more information.
  • Please ensure that continued supply by the patient’s GP is possible. If the GP refuses then the Trust may have to fund and supply long-term treatment.
    For an in-patient – the medicine will only be ordered after the request has been approved. Please note that it may take up to 48 hours before pharmacy obtains and supplies stock.
    For a patient seen in an out-patient clinic – inform the patient that this medicine is not available and there may be a delay; they will be contacted later. DO NOT SEND PATIENTS TO PHARMACY. Please do not request the GP to prescribe the medicine as it is likely to be refused. Requests are deemed to be non-urgent and the approval process can take up to two weeks.

Unlicensed Medicines

  • This form does not cover the use of licensed medicines for an indication not included in the product license details, i.e. ‘off-label’ use. The prescriber must take their own responsibility for using a medicine in this way.
  • The majority of medicines sold to or prescribed for patients in the UK have a Marketing Authorisation (MA) issued by the Medicines and Healthcare Products Regulatory Authority (MHRA), or a pan-EU Marketing Authorisation issued by EMA (European Medicines Agency). However in order to meet the needs of some patients it is sometimes necessary that they receive treatment with a product that does not have a marketing authorisation in the UK (i.e. an unlicensed medicine).
  • ​​​​​​​​​​​​​​Unlicensed medicines should not therefore be used unless their use can be justified. Justification may include recognised clinical guidelines, common practice, peer support, or advice of a specialist.
  • Responsibility for deciding if the patient has ‘special needs’ which a licensed product cannot meet falls upon the doctor responsible for the patient’s care. ​​​​​​​​​​​​​​The prescriber assumes legal liability when he/she prescribes an unlicensed medicine. The prescriber must be satisfied that there is a sufficient evidence base and/or has experience of using the medicine to demonstrate its safety and efficacy..​​​​​​​
  • Where possible the clinician should give the patient (or appropriate relatives/carers) sufficient information about the medicine and its possible adverse effects; this should be recorded in the patient’s notes. In circumstances where the patient may be considered to be at increased risk, clinicians are advised to obtain written consent from the patient (or relative).
  • ​​​​​​​It is important that junior medical and nursing staff is aware of the additional risks and responsibilities with regard to unlicensed medicines. They should be given sufficient information as to the handling, administration, monitoring the patient, and dealing with possible adverse events etc. The pharmacy staff may be able to help with the provision of this information if required.
  • Any adverse drug reactions (ADRs), defect (or suspected defects) of the product must be reported to the hospital pharmacy.​​​​​​​​​​​​​​​​​​​​
  • Prescribers are advised to read the General Medical Council (GMC) guidance on prescribing unlicensed medicines:
    ​​​​​​​http://www.gmc-uk.org/guidance/ethical_guidance/14327.asp

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Patient Details

Please give patient details

By completing and submitting this form, I agree that there is no appropraite formulary medicine and the above will only be prescribed by me or on my instructions for the indication and the reason stated above. I also read and taken note of the guidance provided in the form. Approval to use an unlicensed medicine may be withdrawn should problems arise with safety, or if a suitable licensed alternative becomes available.

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