No medicine can be placed on the market without a Marketing Authorisation (formerly known as a Product Licence) granted by the Medicines and Healthcare Products Regulatory Authority (MHRA). This Marketing Authorisation signifies that the medicine concerned meets the appropriate quality standards and is safe and efficacious for its designated use. However, fully licensed products will not always meet the clinical needs of an individual patient in every situation. Therefore, the legislation provides an exemption to allow the manufacture, supply and administration of unlicensed medicines (i.e. medicines without a Marketing Authorisation) when necessary. In addition, provision is also made for licensed medicines (i.e. medicines with full Marketing Authorisation) to be prescribed for unlicensed indications, in unlicensed dosages or in unlicensed formulations i.e. "off-label".
The following issues must be considered before prescribing an unlicensed / off-label medicine:
- Unlicensed medicines and off-label medicines should only be prescribed if their use can be clearly justified from a clinical / pharmaceutical perspective.
- Products with the appropriate Marketing Authorisation should be used to treat patients in preference to unlicensed medicines or off-label use whenever possible. However, use of unlicensed / off-label medicines may be necessary in order to provide the optimum treatment for patients.
- The decision to prescribe unlicensed medicines may only be made by a consultant.
- Any practitioner prescribing an unlicensed medicine or a licensed medicine for an unlicensed indication must take responsibility for their actions. The prescriber carries the burden of the patient's welfare and in the event of adverse reactions may be called upon to justify the decisions that they have taken.
- Appropriate documentation must be completed by the responsible consultant before an unlicensed medicine or a high risk off-label medicine is prescribed as per NHSGGC Unlicensed Medicines (ULM) Policy. Clinical pharmacists can advise further on the process and when forms need to be completed.
- Suitable patient information should be provided and informed consent obtained for patients prescribed unlicensed medicines.
- Appropriate arrangements must be made for continuity of supply when a patient is required to continue to take an unlicensed medicine after their discharge from hospital (see Policy for more details).
- The full policy together with the appropriate forms and some frequently asked questions can be found within the medicines policies section of the GGC Medicines website at www.ggcmedicines.org.uk