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Originator: National Patient Safety Alert - DHSC

Issue date: 30-Jul-2024 15:20:01

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Special Health Authorities
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Integrated Care Boards

Action category: Action

Title: Shortage of Human Albumin 4.5% and 5% dose vials

Broadcast content:

There will be limited stock of Human Albumin from July 2024 until at least December 2024. Resolution date for a resumption of full market coverage is still to be confirmed.

The supply disruption is caused by a combination of increased global demand for Human Albumin resulting in one supplier being unable to bring in sufficient stock and a sustained overall increase in demand for the product.

Volumes of Human Albumin 20% remain available but cannot support an uplift to meet the additional demand from the 4.5% and 5% preparations.

Human Albumin is licensed for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate. However, in practice it is used extensively for:

  • Plasma expansion after paracentesis
  • Plasma exchange in neuroinflammatory crises
  • Treatment of hepatorenal failure in association with terlipressin

Remaining volumes of Human Albumin should be prioritised for patients that clinical leads have indicated are critical.

This National Patient Safety Alert provides further background, clinical information and actions for providers.



Additional information: This alert is not relevant to Primary Care.

Alert reference: NatPSA/2024/009/DHSC

Action underway deadline: 01-Aug-2024

Action complete deadline: 07-Aug-2024

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency