This report makes ten balanced recommendations on the prescription of a drug outside the narrow terms of its market authorisation, while remaining within current psychiatric practice.
Key Messages for clinicians
- 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).
- 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.
- Get 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.