S2E4: The UK blood donor deferral has lifted. What does this mean for Aussie donors?

A rule banning many former UK residents and visitors from giving blood in Australia has lifted. What does this mean for Australian blood donors and the donor blood supply? In our fourth episode of season two, RCPA President Dr Lawrie Bott discusses this with Lifeblood's Professor Iain Gosbell.

Transcript

00:00:00:23 - 00:00:15:18

[Voiceover]

Welcome to the Pathologist Cut podcast. This RCPA podcast explores the broad medical specialty of pathology and the critical role pathologies play in medicine and health care.

00:00:17:22 - 00:00:49:04

[Dr Lawrie Bott]

Welcome to another RCPA podcast. Today we will be talking to Professor Iain Gosbell about recent changes to blood donation eligibility in Australia. Professor Gosbell is the medical director of donor and product safety at AustralIain Red Cross Lifeblood. Professor Gosbell is also a foundation professor of Infectious Diseases and Microbiology at the School of Medicine, Western Sydney University Thanks for joining us today.

00:00:49:05 - 00:00:51:09

[Prof Iain Gosbell]

A pleasure, Lawrie.

00:00:52:07 - 00:01:03:00

[Dr Lawrie Bott]

Iain. Blood transfusion is such a key procedure in saving the lives of many AustralIains. What are the risks in having a blood transfusion and how do we make it safer?

00:01:03:23 - 00:01:32:12

[Prof Iain Gosbell]

Yeah, thanks, Lawrie. The patient risk actually quite rare today. A lot has happened in the past few decades in transfusion medicine with respect to the blood borne viruses. Actually, they have safety risks that are far less than one in a million platelets uniquely predisposed to bacterial contamination because they kept that room temperature. You get a case of an infection transmission by that every couple of years.

00:01:32:12 - 00:02:01:14

[Prof Iain Gosbell]

We put new measures in place to reduce this further with respect to other kinds of reactions you can get from a transfusion. Febrile non haemolytic reactions are probably the commonest in about one in a thousand and delayed haemolytic reactions one in 11,001 that's very concerning transfusion related acute lung injury. We've put in a number of mitigations here and which is that to four to six cases per annum throughout the whole country.

00:02:02:04 - 00:02:36:18

[Prof Iain Gosbell]

We also consider donor issues with the safety as well. So the issues with being a donor might include getting a bruise from the phlebotomy. You can get infiltration, particularly with the plasma for ASIS we actually take more plasma donations than the whole blood donations. Now Lawrie, there's been a big upswing in the demand for intravenous immunoglobulin Lent and other plasma derived medications, and we've been striving to boost how much plasma we get from Australian donors to try and get at least partially self-sufficient in these plasma products.

00:02:37:11 - 00:02:53:16

[Prof Iain Gosbell]

So on the safety thing, we have to get a balance between the rights of someone to their blood donor and people are often very passionate about this versus the ability to supply hospitals with the blood products that they need for the patients.

00:02:54:05 - 00:03:03:03

[Dr Lawrie Bott]

Can you tell me the background to Variant Creutzfeldt-Jakob disease in the UK and what dangers did it create for the safety of the Australian blood supply?

00:03:03:24 - 00:03:36:18

[Prof Iain Gosbell]

Yes, so Variant Creutzfeldt-Jakob disease in these days was a near fatal neurological disease, recognized in the 1990s in people, but there was some bovine spongiform encephalopathy in cows in the United Kingdom in particular in the 1980s and 1990s. And the reason that this arose was because of agricultural practices of feeding bovine tissues including neurological tissues as part as food for the cattle.

00:03:37:11 - 00:04:08:13

[Prof Iain Gosbell]

Unfortunately, this crossed over to humans in 1995, the first human case in a very young person, 19 year old, and then there was a spate of cases and then the connection was made to eating beef from these impacted cattle and it was realized that probably 190,000 infected cattle probably into the food chain. And so rules were tightened around agriculture you will see practices in 1996 to prohibit feeding cattle to cattle essentially.

00:04:08:13 - 00:04:20:09

[Prof Iain Gosbell]

And this stopped the transmission of bovine spongiform encephalopathy. But the epidemic in the humans was developing at that point and then peaked.

00:04:21:16 - 00:04:29:09

[Dr Lawrie Bott]

It sounds like an extraordinary scientific achievement to have made that connection with beef. You've settled on that achievement.

00:04:30:05 - 00:04:54:12

[Prof Iain Gosbell]

Yes. It was sort of cutting-edge science at the time, but there was an unexplained spongiform encephalopathy in humans at the same time as a new spongiform encephalopathy in the cattle. And then they were able to determine that the kind of prion that was in the cows was the same as the prion that was in the humans, and that the pathology of the brain was spongiform encephalopathy.

00:04:55:07 - 00:05:26:08

[Prof Iain Gosbell]

And there was materially different features from that face CJD in humans to classical VCJD In terms of what tissues were impacted and that. So it was really a lot of strands of evidence were put together to make that link. And it was really quite an important link firstly to the Agriculture Government authorities in the UK to prohibit this field practice in the cattle and then to model how much of an epidemic we were going to get.

00:05:27:00 - 00:05:32:09

[Dr Lawrie Bott]

So what did Lifeblood specifically do to ensure the safety of our blood supply?

00:05:33:04 - 00:06:05:00

[Prof Iain Gosbell]

So when this emerged in the UK, in parallel with blood services throughout the world, introduced a precautionary deferral, we didn't know whether this devastating new disease might transmit by blood and there were more and more cases being discovered in the UK in particular. But other countries in Europe. And so, in December 2000 we introduced a deferral so that if you spent time in the UK greater than six months between 1990 and 1996, you got a permanent deferral.

00:06:05:11 - 00:06:28:08

[Prof Iain Gosbell]

And pretty much countries throughout the world introduced the deferral. Of course, in the UK it was very problematic day for plasma products. They had to import their plasma products, but with respect to fresh blood they were continually using that because they really had to use something. Now after they introduced the deferral, this is when we got the reports that there were transfusion transmitted cases.

00:06:28:08 - 00:06:59:06

[Prof Iain Gosbell]

There's three of these and possibly four or five. They're all in the UK and I think this showed that it was just as well that the Blood Services introduced this deferral as a precautionary measure. And so, since those deferrals were brought in, there were no other cases of transfusion transmission of VCJD. The modelling at the time showed that there was potential for a huge epidemic of human cases, but probably very secure to say that the numbers were very small.

00:06:59:07 - 00:07:35:01

[Prof Iain Gosbell]

233 reported cases of which 178 were in the UK, and the epidemic peaked in 2000 and the decline was fairly rapid, such that it pretty much went away in 2015. We've done two cases since that year, so since it's actually gone away we thought maybe it's time to revisit this deferral and whether the geographic deferral is still needed now because it was very important to get it right and would be very bad if we had a transfusion, transmit the CJD.

00:07:35:10 - 00:08:00:16

[Prof Iain Gosbell]

We enlisted the assistance by statistics and epidemiologic colleagues at the Kirby Institute at the University of New South Wales, and we also enlisted a colleague from the TGA who had previously done some modelling work on basically each day for the TGA to develop a collaborative project to ultimately submit the case to the blood regulator, which is the Therapeutic Goods Association of Australia.

00:08:01:03 - 00:08:25:06

[Prof Iain Gosbell]

This is funded by an HMRC partnership grant, and the work's actually recently been published in Vox Synchronous, where time McManus is the first author. So this whole process was very involved and it took five years. In fact, Lawrie from instigation to actually getting this deferral listed and we did wonder at times whether we were going to get there.

00:08:25:19 - 00:08:54:06

[Prof Iain Gosbell]

So in this modelling work, we had a number variable and these were the current pre symptomatic VCJD cases in the UK looking at the age at infection and the genotype for risk of exposure to cows with BSE between 1990 and 1996, we used the Australian Bureau of Statistics that estimate the numbers of British people in Australia that possibly might have been exposed.

00:08:54:18 - 00:09:26:18

[Prof Iain Gosbell]

And the other thing that we used is published data from a sheep model of this disease and saying whether it can be transmitted by transfusion. And the reason we looked at this is we wanted to know what the effect of lipid depletion on the blood was going to do. So in Australia and in most blood services that we looked at the plate because the white cells can cause reactions with the recipient's tissues causing all sorts of federal and immunological reactions.

00:09:27:00 - 00:10:04:10

[Prof Iain Gosbell]

And if we take out the leukocytes that this is rendered much less common. It also has the side benefit that pathogens such as cytomegalovirus transmitted foreign interests and so if we take out leukocytes then they won't transmit basically. And so in the sheep model, if you didn't they could deplete the sheep blood to transfusion into another shape. There was 0.31 chance of transmitting, whereas if you look depleted that was reduced to point to 9% and so that was a very big reduction in transmissibility by this kind of depletion step.

00:10:04:19 - 00:10:30:18

[Prof Iain Gosbell]

So we put that in the model because that's the adaptation is what we do with the Australian blood by doing this calculation. The bottom line was that our estimate of the risk of transmission in this model, VCJD by blood from an Australian donor was one in 1.4 billion and this event might happen every 65 years. So this is a what you could say is an infinitesimally small risk.

00:10:31:05 - 00:11:03:06

[Prof Iain Gosbell]

And the other thing to point out is that this model is probably we consider it to be a worst case scenario and there's never been a reported case of VCJD in this country. And so this estimate is one in 1.4 billion is probably an overestimate and so the risk is in reality is probably zero. So anyway, we submitted that argument to the TGA and they have allowed us to remove this deferral on the 25th of July 20, 22.

00:11:04:01 - 00:11:19:12

[Dr Lawrie Bott]

No, it's a great achievement. So it was really a risk assessment exercise, would you describe it? With overwhelming statistics showing it was just very, very unlikely that's correct.

00:11:19:23 - 00:11:32:13

[Prof Iain Gosbell]

It really is quite difficult to comprehend what's the difference between one in 1,000,001 in a billion. So, you know, the chance of being hit by an asteroid or something is probably in the same realm of likelihood.

00:11:33:23 - 00:11:38:12

[Dr Lawrie Bott]

How do you think these changes will impact the supply of donated blood then in Australia?

00:11:39:06 - 00:12:11:17

[Prof Iain Gosbell]

Well we calculated that about 750,000 folks in Australia potentially could come along if we removed this deferral and we estimated that perhaps 18,000 donors could come back and might donate 57,000 donations per annum, which is about 1100 donations per week. So we removed this deferral this year. Now on the 25th of July 20, 20, and we got an outstanding response and we were quite surprised, I'd have to say.

00:12:12:07 - 00:12:41:15

[Prof Iain Gosbell]

So in the period of the months after that we in fact got 6669 new donors that would have had that deferral. So we pretty much got up to what we estimated for a year in the first months and in the first week we got 3200 blood and 700 plasma donations from these people that would have previously had the deferral of blood donations.

00:12:41:15 - 00:13:14:01

[Prof Iain Gosbell]

It's plateaued, it looks like maybe it might be one and a half thousand per week. And remember, we thought we might get 1100 per week. And the plasma, when this deferral was brought in plasma for ACS donation was unusual, whereas this is actually our biggest loss and now it's got more donations for plasma for a since then there are whole blood donations basically there's a thirst in clinical land for IVIG in particular, and other plasma derived medicines.

00:13:14:16 - 00:13:45:11

[Prof Iain Gosbell]

And so we're trying to be self-sufficient as we can with supplying this. So anyway, the doses come back and now able to do plasma and you can do plasma up to a fortnight to a maximum of 26 donations in a year. And it might surprise you, Larry, that there are enthusiasts that donate with that frequency. It's probably fair to say that it is unusual, but plasma donors will typically do six or eight or something like that per year.

00:13:45:24 - 00:14:19:10

[Prof Iain Gosbell]

And so with whole blood because you donating iron to us, we don't allow it more frequently than every three months. But you can fit in 26 plasma and four whole floods in a year if you're an enthusiast. So we're quite optimistic saying this plasma for ACS codes going up and up and up, that maybe these new donors have discovered that there is an another way to donate and this is really quite an important product to be getting from our current donors.

00:14:20:19 - 00:14:24:19

[Dr Lawrie Bott]

It sounds very significant to me what you've described yeah.

00:14:24:19 - 00:14:40:24

[Prof Iain Gosbell]

So we're doing 1.6 million donations per annum and about 55% of plasma and the donor panel in total is some 500,000 people and we're hoping to grow it to perhaps six, 600,000.

00:14:42:01 - 00:14:47:20

[Dr Lawrie Bott]

So do we have enough donation in Australia or we always living with the need to have more.

00:14:48:12 - 00:15:11:20

[Prof Iain Gosbell]

All of the products have a shelf life, particularly platelets. We've extended the type that shelf life and five days to seven days and that was one of our other major projects to show that this was a safe thing to do and that was really very helpful with that inventory. With respect to red cells, the shelf life is 42 days.

00:15:11:20 - 00:15:37:11

[Prof Iain Gosbell]

You might remember there was a campaign and it got on the growing factor about the magic number 42, which is six weeks. And so the red cells that comes in various blood groups abo and the races positive and negative. And so vaccinations do like to prescribe out the negative a lot and there are moves afoot to perhaps quell their enthusiasm for that.

00:15:37:14 - 00:16:06:15

[Prof Iain Gosbell]

However, in general, we actually have a department that matches supply with demand and so we don't want to have a situation where there has to be discussions with our transfusion medicine specialists about whether you can have this or that blood products with codes, that people's behaviour has changed a little bit. And so you've probably noticed that there have been multiple call outs for people to become blood donors and sit at night perhaps more frequently.

00:16:07:01 - 00:16:36:00

[Prof Iain Gosbell]

And that's because our inventory stocks have been at the lower end of the range a bit more than what we like. There is contingency plans in place should it get desperately low, but it's never got to that kind of level. And certainly, with this removal of the VCJD deferral, it helped a lot. That sort of the issue with that is really that you need to have fresh platelets and relatively fresh red cells for transfusion into people.

00:16:36:00 - 00:17:02:10

[Prof Iain Gosbell]

The FSP, we can phrase it for up to a year. And so there's not really inventory problems with that because we can address that over 12 months time frame with respect to plasma that's used for plasma, for fractionation, we're sort of supplying about half of the plasma. Is that the strain doctors are prescribing? And we'd like to have it a bit higher than that.

00:17:02:18 - 00:17:25:01

[Prof Iain Gosbell]

You might be surprised to know that most of the world's plasma products are actually coming from the United States and Germany. They're supplying all of the rest of the world basically, which is very unusual. It also means that if there's only one or two suppliers, that supply chain issues might occur. And so we are very keen to be not in that situation.

00:17:25:01 - 00:17:45:02

[Prof Iain Gosbell]

So we're boosting the plasma harvest. So there's not a shortage in the short term in terms of having to ration product, but certainly we want to get more plasmas. So you could say that it's kind of a balancing juggling act to make sure that we've got exactly the right amount of blood products in our refrigerators, in our faces.

00:17:45:24 - 00:17:55:08

[Dr Lawrie Bott]

So it's COPE has been a challenge from the donation side as have been a challenge in terms of the virus itself getting into the blood supply.

00:17:55:14 - 00:18:19:12

[Prof Iain Gosbell]

With respect to kind of a time we were on the case in December 2019 and in January 20, 20, we saw this is going to be a big one. We do active horizon scanning for emerging infectious diseases and when we detect one of these we have to do a rapid risk assessment as to is it going to transmit or not.

00:18:19:21 - 00:18:44:07

[Prof Iain Gosbell]

And of course when you've got a new pathogen, there's often not a lot of data about this. But the initial assessment was that the risk from transfusion was probably infinitesimally small and we've had to assess that multiple times during the pandemic. And we always thought it was quite amazing that even though there's probably billions of cases now, there's been not one single episode of the transmission by a blood transfusion.

00:18:44:14 - 00:19:00:15

[Prof Iain Gosbell]

So it saves it's the one way you can't get it. And it wouldn't be someone who's sick, who would be the risk donor, would be someone who's asymptomatically infected. So with respect to COVID, we've certainly been very busy since 2020.

00:19:01:08 - 00:19:13:09

[Dr Lawrie Bott]

It's extraordinary times. And as a final question, which we ask all speakers, do you have any comments for medical students and junior doctors contemplating a career in pathology?

00:19:14:07 - 00:19:40:11

[Prof Iain Gosbell]

Yes, we're obviously quite passionate about pathology. It's very interesting. It's fun and you get paid well, the lifestyle is pretty good for those that consider it. There's lots of different kinds of pathologies too, and people need to consider that. Microbiologist, haematologists, immunologist, lots of other allergists, of course, anatomic pathologists, and we work in different areas, not just hospitals, obviously work in Lifeblood.

00:19:40:11 - 00:20:09:17

[Prof Iain Gosbell]

Blood transfusion medicine specialist is Lifeblood, so and haematologist. And we've got multiple microbiologists now in the organization who work for government and industry and pathology probably don't have to tell you that makes such a profound contribution to medicine, all the diagnosis is made by pathology and all the advances are pathology. And there's so many research and teaching options and you're always learning new and interesting things.

00:20:10:02 - 00:20:16:20

[Prof Iain Gosbell]

And personally, I've had no regrets about being a pathologist. So that's what I would say briefly to someone who is contemplating it.

00:20:17:01 - 00:20:21:23

[Dr Lawrie Bott]

Thank you. You know, a great career, a great profession. The heart and soul of medicine.

00:20:22:09 - 00:20:23:04

[Prof Iain Gosbell]

That's right.

00:20:23:21 - 00:20:29:17

[Dr Lawrie Bott]

Well, and thank you for a wonderful outline of how we keep our blood supply safe in Australia.

00:20:30:15 - 00:20:33:09

[Prof Iain Gosbell]

No worries. Thank you for inviting me to do the podcast.

00:20:35:13 - 00:20:50:20

[Voiceover]

You have been listening to the Pathologist Cut Podcast with us, RCPA president Dr Lawrie Bott. To learn more about pathology, check us out on Facebook, Instagram and Twitter.