Article Text

Download PDFPDF

2SPD-006 Development of a prioritisation protocol for the use of immunoglobulins in view of the global supply problem
  1. M Mejias Trueba1,
  2. M Zaforteza Dezcallar1,
  3. M Vilanova Bolto2,
  4. J Ramakers Ramakers3,
  5. L Pallares Ferreres4,
  6. F Miralles Morell5,
  7. A Cladera Serra6,
  8. O Delgado Sánchez7,
  9. M Cañellas Fuster8,
  10. JA Salinas Sanz9,
  11. J Pons De Ves10
  1. 1Servicios Centrales de las Islas Baleares, Servicios Centrales, Palma de Mallorca, Spain
  2. 2Hospital Son Llatzer, Pharmacy Service, Palma de Mallorca, Spain
  3. 3Hospital Son Espases, Paediatric Immunodeficiency and Rheumatology Unit, Palma de Mallorca, Spain
  4. 4Hospital Son Espases, Internal Medicine Unit, Palma de Mallorca, Spain
  5. 5Hospital Son Espases, Neurology Unit, Palma de Mallorca, Spain
  6. 6Hospital Son Llatzer, Haematology Unit, Palma de Mallorca, Spain
  7. 7Hospital Son Espases, Pharmacy Service, Palma de Mallorca, Spain
  8. 8Servicio de Salud de las Islas Baleares, Paediatrician Regional Coordinator, Palma de Mallorca, Spain
  9. 9Hospital Son Espases, Paediatric Haemato-Oncology Unit, Palma de Mallorca, Spain
  10. 10Hospital Son Espases, Immunology Unit, Palma de Mallorca, Spain


Background and importance Highly purified immunoglobulins (95%) are obtained from the purification of human plasma extracted from healthy donors. The mechanism of action consists of an antigen-specific activity, exerting immunomodulatory functions in addition to those of the natural immunoglobulins. The increase in demand, the dependence exclusively on plasma donations, and the pandemic situation have reduced the supply of immunoglobulins worldwide.

Aim and objectives To elaborate a protocol at regional level (seven hospitals) to prioritise, rationalise and reduce the use of immunoglobulins in view of the worldwide supply problem.

Material and methods A multidisciplinary work team was created comprising professionals involved in the use of these therapies (immunologists, haematologists, internists, neurologists, paediatricians and pharmacists). The main pathologies involved were specified.

Subsequently, the indications depicted in the technical data sheet and the available scientific evidence were reviewed, to define three priority groups:

  • Priority 1: Necessary treatment, there is no other therapeutic alternative.

  • Priority 2: Pathologies or clinical situations where the use of immunoglobulins is recommended.

  • Priority 3: Clinical situations without sufficient scientific evidence.

Finally, the indications and dose regimen of all patients under active treatment were reviewed.

Results The work team defined Priority 1 as follows:

  • Chronic treatments: primary and secondary immunodeficiencies, CAR–T hypogammaglobulinaemia in paediatrics, pure motor chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy.

  • Acute treatments: Kawasaki disease, primary immune thrombocytopenia (PIT) before undergoing urgent surgery or PIT with severe thrombopenia/large bleeding diathesis.

Priority 2 included: Guillain-Barré syndrome, myasthenia gravis, PIT with high risk of bleeding, CIDP (excluding pure motor), severe neonatal sepsis, alloimmune haemolytic disease in neonates, alloimmune neonatal thrombocytopenia, haemophagocytic syndrome and paediatric multisystem inflammatory syndrome due to SARS-CoV-2.

Pathologies not mentioned above were considered Priority 3, being evaluated by a multidisciplinary Experts Committee.

After reviewing the active treatments, 21% of them were temporarily suspended. Since the protocol approval, eight new cases have been assessed as Priority 3, with only one of them being denied.

Conclusion and relevance The creation of the protocol has made it possible to rationalise the use of immunoglobulins, reducing their consumption and promoting the use of therapeutic alternatives. Thus, completely necessary treatments are guaranteed through equitable and equal access throughout the region.

Conflict of interest No conflict of interest

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.