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The Royal College of Psychiatrists Improving the lives of people with mental illness

CR210. Use of licensed medicines for unlicensed applications in psychiatric practice (2nd edition)


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Approved: Oct 2017

Published: Dec 2017

Status: current

Number of pages: 17

Review by: Dec 2022

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Pharmacological treatment is an important component of much of psychiatric practice. Many psychotropic medications and psychological interventions are available for patients with mental health problems, but patients often remain troubled by distressing symptoms despite undergoing a series of pharmacological and psychological treatments. In this situation, doctors may wonder whether they might prescribe a medication outside the narrow terms of its market authorisation (‘product licence’) in an attempt to improve clinical outcomes. Many authorities agree that use of a drug outside the terms of its licence can be a necessary and beneficial part of clinical practice, whereas others have raised concerns about patient safety and medical liability.

The Royal College of Psychiatrists first issued guidance on recommended procedures for the use of licensed medicines for unlicensed applications in psychiatric practice in 2007. In the subsequent decade, evidence on this aspect of practice has increased and other bodies have also provided guidance (e.g. General Medical Council, 2013). The Royal College of Psychiatrists’ Psychopharmacology Committee was therefore asked to consider and, if necessary, revise current College guidance and did so in consultation with representatives from the British Association for Psychopharmacology (BAP). We considered the potential benefits and risks of this aspect of clinical practice and believe that prescription of a drug outside the narrow terms of its market authorisation can be an appropriate part of overall management and in the best interests of a patient. The Committee strived to make ten balanced recommendations that it judged would be feasible to implement within current psychiatric practice.


Recommendations

  1. First check that medicines with a licence (market authorisation) for the particular indication have either had an adequate therapeutic trial or have been considered carefully but excluded on clinical grounds (such as treatment contraindications or risk of drug–drug interactions).

  2. Become familiar and be satisfied with the evidence base for the proposed pharmacological intervention, including its probable effectiveness, acceptability, treatment-emergent adverse effects, and drug interactions.

  3. Obtain the advice of another prescribing clinician (and possibly a specialist pharmacist) with greater experience or expertise if the medicine to be used does not have an extensive evidence base to support its use for the proposed indication, or if you have particular concerns, or if you feel insufficiently expert in this field.

  4. Consider the anticipated risks and benefits of treatment, giving particular thought in vulnerable groups such as children and adolescents, women of child-bearing age, elderly patients, physically ill patients, and patients with impaired insight and judgement; and document your thoughts on the likely balance of risk and benefit.

  5. Explain fully the anticipated benefits and potential risks of the proposed medication to the patient (and if possible their relative or partner) stating that the medicine will be used outside the restricted terms of its product licence and make a record of this explanation.

  6. In a situation where prescribing an unlicensed medicine is supported by authoritative guidance, describe in general terms why the medicine is not licensed for the proposed indication, but if you intend to prescribe an unlicensed medicine where that is not routine, provide the patient with a more detailed explanation.

  7. Record the agreement of the patient to the proposed intervention. If the patient is unable to provide consent to a necessary treatment, document that it has not been possible to obtain formal consent.

  8. Start the medicine at low dose and monitor its effects carefully. If it is well tolerated but not effective, give thought to cautiously increasing the dose, with further careful monitoring of its effects.

  9. Tell other health professionals involved in the care of the patient that the medicine is being prescribed outside the terms of its licence and encourage them to discuss their observations of its beneficial and untoward effects.

  10. If the medicine has no beneficial effects or the emergent risks and hazards outweigh the benefits, withdraw it (generally, best done gradually) and document the reasons why it is being withdrawn. If there is a persistent need for further treatment, consider possible alternatives (using the process described above) and after a suitable ‘wash-out’ cautiously introduce the next medicine.

 

 

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Please note: In March 2015, the review date for this report was extended to 2016.