The Efficacy and Safety of Prescribing in Transplantation (ESPRIT) multi-disciplinary group has issued a consensus statement on the implications of, and practical recommendations for generic immunosuppressants for transplantation.

The group discusses the potential for errors in prescribing immunosuppressants in the transplant setting, especially in paediatric patients who may be on various capsule, liquid, and granule formulations of their different immunosuppressants.

The following recommendations have been made (taken directly from source):

• The only practical way to ensure safety of transplant patients, both adults and children, is for any change in immunosuppressant treatment to be initiated in secondary care under specialist medical supervision, with appropriate monitoring.
• All prescriptions, and related correspondence, should specify the brand on which the patient is stabilised, the dose and the frequency – be it the originator brand or a generic immunosuppressant.
• Everyone in a position to influence safe prescribing of immunosuppressants, from transplant consultants through to the patients themselves, should be aware of these recommendations and seek to reinforce their implementation.

The document also highlights that generic products are not licensed on the basis of clinical assessment in the relevant patient group, but on simple bioequivalence assessment, generally in a small number of healthy volunteers. Thus licensed bioequivalence does not automatically mean clinical equivalence in practice.

Please see attached document for details.