Limited availability of intravenous immunoglobulins: recommendations to the attention of hospital pharmacists and the physician-specialists within hospitals where there is an availability problem.

Through possible limited availability of intravenous immunoglobulins, there is a threat of a shortage in some hospitals in Belgium. The Federal Agency for Medicines and Health Products (FAMHP) is giving recommendations for hospital pharmacists and physician-specialists within the hospitals.

To find a short term solution for any stock shortages of essential medications, a Task Force of experts can be convened within the “unavailabilities” working group. In order to handle the situation of intravenous immunoglobulins as well as possible, the Task Force formulated the following recommendations:

The Task Force advises to switch to subcutaneous immunoglobulins if clinically possible and to take into consideration the individual patient situation within the provisions or article 3410000.  As a reminder, subcutaneous immunoglobulins are only reimbursed for the following indications:

  • primary immune deficiency syndromes (PID)
  • chronic lymphatic leukaemia (CLL) or multiple myeloma (MM)
  • with serious secondary hypogammagobulinemia with life threatening or recurrent clinically significant infections 
  • Relevant B-cell malignancy or latrogenic B-cell deficiency through the use of monoclonal antibodies or chemotherapy with serious secondary hypogammagobulinemia with life threatening or recurrent clinically significant infections 

The task force emphasizes the importance of prescribing intravenous immunoglobulins rationally, and only within the reimbursable indications. The reimbursable indications are already limited, which makes prioritizing difficult. In this it is important to limit inappropriate or off label (non-reimbursable) use as much as possible, so that the product is available in the first instance for the indications which are reimbursed. As a reminder, intravenous immunoglobulins are reimbursed for the following indications articles 6790100, 6790200, 6790300 and 6790400:

  • primary immune deficiency syndromes (PID)
  • chronic lymphatic leukaemia (CLL) or multiple myeloma (MM)
  • with serious secondary hypogammagobulinemia with life threatening or recurrent clinically significant infections 
  • Relevant B-cell malignancy or latrogenic B-cell deficiency through the use of monoclonal antibodies or chemotherapy with serious secondary hypogammagobulinemia with life threatening or recurrent clinically significant infections 
  • idiopathic thrombocytopenic purpura (ITP)
  • Guillain-Barré syndrome
  • Kawasaki's disease
  • Serious invasive infections with  group A streptococci with streptococci toxic shock syndrome
  • Chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Multifocal motor neuropathy (MMN)
  • Allogenic or autologous stem cell transplant with serious secondary hypogammagobulinemia with life threatening or recurrent clinically significant infections 

The task force advises not to stockpile unnecessary inventories.

The FAMHP is closely following the situation and is working with the RIZIV, Ministry of Public Health and the policy department in the search for additional solutions.

 

Last updated on
29/04/2019