Inspired Question · S5W-25219 · Session 5
Whether it has plans to amend the blood safety requirements for plasma and platelets, in light of expert advice.
The question
To ask the Scottish Government whether it has plans to amend the blood safety requirements for plasma and platelets, in light of expert advice.
The answer
Along with the UK Government and the Welsh Government, the Scottish Government has agreed to update some specific variant Creutzfeldt-Jakob disease (vCJD) precautionary measures in Scotland, England and Wales.
In 2004, the Scottish Government was advised to establish precautionary vCJD risk reduction measures in the UK, acknowledging the unknown risks of vCJD to recipients of UK plasma and platelets. A number of measures were introduced, such as the introduction of leucodepletion of all blood components and the deferral of previously-transfused donors. These specific risk reduction measures are highly effective and will remain in place to maintain the safety of the UK blood supply.
An additional risk reduction measure adopted involved the treatment of patients born on or after 1 January 1996 with imported plasma and/or apheresis platelets, along with providing imported plasma for patients with Thrombotic Thrombocytopenia Purpura (TTP, a rare blood disorder). This was to reduce the risk of exposure to components that were thought to have potentially increased their risk of developing vCJD.
Over the last 15 years, accrued scientific evidence has indicated that the risk of vCJD through the transfusion of UK plasma or platelets is much lower than initially thought; there have been no known transfusion transmissions of vCJD from any blood components since the leucodepletion process was introduced. In March 2019, the independent Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) reviewed the scientific evidence and operational practices and engaged with stakeholders. As a result SaBTO has recommended that the specific risk reduction measures requiring the use of imported plasma and apheresis platelets for individuals born on or after 1 January 1996 and imported plasma for patients with TTP can be withdrawn.
SaBTO’s final advice has been published, providing a comprehensive analysis of the risk attributed with updating these vCJD risk reduction measures. This advice is available online at: https://www.gov.uk/government/collections/sabto-reports-and-guidance-documents .
In light of SaBTO’s advice, the Scottish Government has approved the use of domestic plasma and pooled platelets for patients born on or after 1 January 1996 and of domestic plasma for patients with TTP. Other risk reduction measures will remain in place, including leucodepletion, deferral of previously-transfused donors and a ban on the manufacture of plasma-derived medicinal products from plasma sourced in the UK.
The Scottish National Blood Transfusion Service (SNBTS) already sources the majority of plasma from donors in Scotland and increasing domestic plasma use will provide further benefits relating to equitable provision of blood components, reduced operational complexity for hospitals and increased accessibility at the point of use. Clinicians who wish to prescribe and source commercial imported plasma for patients, based on patient need and clinical preference, will continue to be able to do so.
The Scottish Government has therefore asked SNBTS to begin implementing SaBTO’s recommendations.
In 2004, the Scottish Government was advised to establish precautionary vCJD risk reduction measures in the UK, acknowledging the unknown risks of vCJD to recipients of UK plasma and platelets. A number of measures were introduced, such as the introduction of leucodepletion of all blood components and the deferral of previously-transfused donors. These specific risk reduction measures are highly effective and will remain in place to maintain the safety of the UK blood supply.
An additional risk reduction measure adopted involved the treatment of patients born on or after 1 January 1996 with imported plasma and/or apheresis platelets, along with providing imported plasma for patients with Thrombotic Thrombocytopenia Purpura (TTP, a rare blood disorder). This was to reduce the risk of exposure to components that were thought to have potentially increased their risk of developing vCJD.
Over the last 15 years, accrued scientific evidence has indicated that the risk of vCJD through the transfusion of UK plasma or platelets is much lower than initially thought; there have been no known transfusion transmissions of vCJD from any blood components since the leucodepletion process was introduced. In March 2019, the independent Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) reviewed the scientific evidence and operational practices and engaged with stakeholders. As a result SaBTO has recommended that the specific risk reduction measures requiring the use of imported plasma and apheresis platelets for individuals born on or after 1 January 1996 and imported plasma for patients with TTP can be withdrawn.
SaBTO’s final advice has been published, providing a comprehensive analysis of the risk attributed with updating these vCJD risk reduction measures. This advice is available online at: https://www.gov.uk/government/collections/sabto-reports-and-guidance-documents .
In light of SaBTO’s advice, the Scottish Government has approved the use of domestic plasma and pooled platelets for patients born on or after 1 January 1996 and of domestic plasma for patients with TTP. Other risk reduction measures will remain in place, including leucodepletion, deferral of previously-transfused donors and a ban on the manufacture of plasma-derived medicinal products from plasma sourced in the UK.
The Scottish National Blood Transfusion Service (SNBTS) already sources the majority of plasma from donors in Scotland and increasing domestic plasma use will provide further benefits relating to equitable provision of blood components, reduced operational complexity for hospitals and increased accessibility at the point of use. Clinicians who wish to prescribe and source commercial imported plasma for patients, based on patient need and clinical preference, will continue to be able to do so.
The Scottish Government has therefore asked SNBTS to begin implementing SaBTO’s recommendations.
In the Official Report
No contribution in the Official Report cites S5W-25219 by reference.