Jim Shannon – 2016 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Jim Shannon on 2016-03-16.

To ask the Secretary of State for Health, how many people have reported side-effects related to an organ transplant in each of the last five years.

Jane Ellison

Post-transplant side-effects are monitored by the transplant centre, and all serious adverse events and reactions associated with organ donation and transplantation are required to be reported to the Human Tissue Authority (HTA), in accordance with the Quality and Safety of Organs Intended for Transplantation Regulations 2012.

Under these regulations, a serious adverse reaction is defined as an unintended response, including a communicable disease, in the living donor or in the transplant recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity. The reporting of a reaction does not necessarily mean that someone involved has made a mistake. For example a donor may have an infection that was not known or indeed detectable at the time of donation.

The available information is shown in the following table:

Organ Donation and Transplant

Reported serious adverse reactions* in the United Kingdom, 2012 to 2016

	2012/2013** (Q3 and Q4)	2013/2014	2014/2015	2015/2016 (up to and including Q3)
Serious adverse reactions	5	12	10	10

Source: HTA

Notes:

* The data is not reflective of all side effects associated with transplantation, since they are limited only to serious adverse reactions associated with the quality and safety of the transplanted organs.

** the requirement for transplant centres to report Serious Adverse Reactions set out in Quality and Safety of Organs Intended for Transplantation Regulations 2012, commenced 27 August 2012.

NHS Blood and Transplant (NHSBT) is responsible for investigating the reports it receives from relevant clinical personnel, and reports to the HTA incidents which meet the definition under the 2012 Regulations. It also notifies the HTA of the steps being taken to manage the reported events or reactions and provides confirmation that all actions have been concluded. NHSBT then feeds back to the clinical community to share learning and promote best practice from incidents both in the UK and across Europe.

NHSBT also works with professional and patient organisations to ensure that all potential transplant recipients are given as much information as possible about the risks as well as the huge benefits of transplantation.