IBTS to introduce further changes to its donor eligibility policies

December 21st, 2021

 

In 2020, a Social Behaviour Review Group was established to review the current blood donor deferral policies of the Irish Blood Transfusion Service (IBTS). The group was Chaired by Professor Mary Horgan and membership included IBTS Donor Consultants, Infectious Disease Physicians, Public Health Physicians, an Epidemiologist, and the IBTS Risk & Resilience Manager. Stakeholders were represented by participants from the Irish Haemophilia Society (Chief Executive, Brian O Mahony), Sickle and Thalassemia Ireland and HIV Ireland.

The Terms of Reference stated that the Advisory Committee will: “review the evidence base for donor selection, deferral and exclusion in Ireland in relation to social behaviours that may increase the risk of acquiring specific blood-borne infections (HIV, HBV, HCV, syphilis and other sexually transmitted diseases).”

The remit included:

• Evaluating the evidence for selection and deferral policies;
• Defining the infections of interest, both known and unknown;
• Reviewing the epidemiology on blood borne infections;
• Assessing the performance of current testing procedures;
• Estimating the residual risks for specific blood borne infections;
• Reviewing relevant policies in other countries including individualised risk-based
assessment;
• Assessing new evidence on donor behaviour and motivation and their impact on
safety;
• Evaluating the operational impact of any recommendations;
• Making recommendations for disseminating the outcome of the review;
• Ensuring that recommendations are in line with current legislation and relevant regulations.

In formulating its advice, the Advisory Committee was tasked to

(a) Take full account of the scientific evidence available, including the nature of uncertainties and assumptions used to reach conclusions;
(b) Consider the impact of its advice on all stakeholders, including but not exclusively donors, patients, the wider HSE, and the public
(c) Take full account of the need to maintain the safety of blood, tissues and cells under the remit of the Precautionary Principle;
(d) Aim to explore possible options to allow as wide a pool of donors as possible
( e) take account of views of interested parties on areas of concern, including concerns regarding discrimination and equity, and address these as far as possible
(f) Identify specific areas of research where further work is required to reduce uncertainty;
(g) The advisory committee will make a recommendation on its findings to the IBTS Medical & Scientific Advisory Committee (M&SAC)

Recommended Changes

A number of changes to donor deferral policies were recommended by the review group and accepted in principle by the Board of the IBTS. The changes were agreed by agreed by the IBTS Board and will be introduced in two phases with the initial phase being introduced by the end of March 2022 and the second phase being introduced later in 2022. Some of the proposed changes will require an additional risk assessment prior to implementation

The current deferral protocol states that a male donor who has had oral or anal sex with another male (MSM) with or without a condom or pre-exposure prophylaxis {PreP} is currently deferred for 12 months after the last sexual contact. It was recommended that the deferral be reduced initially to 4 months but this will be replaced with an individual assessment scheme (For the Assessment of Individualised Risk – the FAIR system introduced by the UK Blood Services). Once the Self-Assessment Health History (SAHH) is introduced in place of the current paper health and lifestyle questionnaire (HLQ) The deferral will only apply to MSM that have anal sex (with or without a condom) and there will be no deferral for oral sex.

Currently, there is a 12 month deferral for any person using HIV pre-exposure prophylaxis. (PReP) This will change to a 4 month deferral for any person on PReP. This will not change again following the individual assessment.

Currently, people with any history of non-prescribed intravenous or intramuscular drug use including recreational drugs, body building steroids or hormones are currently permanently excluded. This deferral is determined by EC Directive 2004/33/EC Annex Ill and therefore will remain unchanged.

Currently, anyone who has sex within the last 12 months with someone who is from an area with a high prevalence of Human Immunodeficiency Virus {“HIV} (e.g. sub-Saharan Africa and South East Asia) is deferred. This question will be removed subject to a satisfactory risk assessment.

Currently, people that have had sex in exchange for money are permanently excluded. It was recommended that a 12 month deferral and individual assessment be considered, subject to a satisfactory Risk Assessment being completed.
Currently, any donor who has snorted cocaine or any other non-prescribed drug has to defer for 12 months. It was agreed to maintain the 12 month deferral.

Currently, any donor who has been imprisoned defer for 12 months after release. This question is considered to be invalid in terms of data that should be retained by the IBTS and therefore should be removed; and it was considered that all risks that may be encountered whist incarcerated in prison would be covered in other questions.

The initial phase of implementation will reduce the existing 12 month deferral for MSM to 4 months. This is an interim measure while the IBTS introduces new technology, to replace the existing paper HLQ)with an electronic questionnaire known as the Self-Assessment Health History (SAHH). This will enable phase two, the introduction of an individual assessment process for donors, thus making blood donation more inclusive. The individual assessment of donors’ sexual behaviour will be similar to the FAIR (For the Assessment of Individualised Risk) system introduced by the UK Blood Services.

The IBTS Medical & Scientific Director Professor Stephen Field stated:

“The independent advisory committee commenced its work in early 2021.The remit of this advisory committee was to review the current evidence base for donor eligibility in Ireland relating to factors that may increase the risk of a donor acquiring specific blood borne infections (HIV, HBV, HCV and other sexually transmitted infections). As always maintenance of the safety of the Irish blood supply for all recipients is our primary concern.”

The present deferral period for MSM was implemented in January 2017 and in the light of evolving international practice a further review was required

We will keep members updated as the new and proposed deferral measures are implemented in the first phase or following the completion of further risk assessments

Brian O Mahony
Chief Executive

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