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CP-064 Analysis of oral immunosuppressant use in off-label indications in a hospital pharmacy service
  1. A Lizardi,
  2. P Carmona,
  3. G Liceaga,
  4. J Barral,
  5. M Umerez,
  6. M Urretavizcaya,
  7. E Esnaola,
  8. MJ Gayán,
  9. MB Irastorza,
  10. MP Bachiller
  1. Donostia University Hospital, Hospital Pharmacy, San Sebastian, Spain


Background Our Hospital Pharmacy Service (HPS) participates in the process of authorising off-label indications (OLIs) of drugs. Immunosuppressants are often used in OLIs.

Purpose To analyse prescriptions for oral immunosuppressants dispensed as OLI in our HPS Outpatient Unit (HPSOU) to identify points in the system that could be improved.

Material and methods Retrospective study of oral immunosuppressants dispensed at our centre between March 2012 and March 2014.

Variables collected were age, sex, drug, prescribing service and indication; obtained from the HPSOU database and the electronic medical history.

Results 269 patients (median age 52 years (5–92), 135 women (50%) and 134 men (50%)) were evaluated.

6 drugs were dispensed in 8 different medicinal products: tacrolimus 94 patients (35%), mycophenolate mofetil 78 (29%), mycophenolic acid 56 (21%), ciclosporin 34 (17%), everolimus 6 (2%) and sirolimus 1 (0.3%).

11 services were involved: Haematology (89 patients: 33%), Rheumatology (61: 23%), Nephrology (56: 21%), Ophthalmology (15: 6%), Digestive (14: 5%), Pneumology (10: 4%), Paediatrics (9: 3%), Neurology (8: 3%), Internal Medicine (4: 1%), Dermatology (2: 0.7%) and Oncology (1: 0.3%).

Immunosuppressants were dispensed for 35 different indications. Main indications and their treatments were: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) for 75 patients (28%), with tacrolimus (71%), mycophenolate mofetil (17%) and ciclosporin (12%); Systemic Lupus Erythematosus (SLE) for 46 (17%), with mycophenolate mofetil (62%), mycophenolic acid (30%) and tacrolimus (8%) and Membranous Glomerulonephritis (MGN) for 20 (7%), with mycophenolic acid (50%) and tacrolimus.

Conclusion The use of oral immunosuppressants as OLI is an established treatment for various indications, specially, allo-HSCT, SLE and GMN. The creation of multidisciplinary groups to develop protocols for the management of these drugs is required.

References and/or Acknowledgements Summaries of product characteristics of the evaluated medicinal products.

No conflict of interest.

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