Plasma derivatives, blood collection is record breaking but we risk not being self-sufficient: why?

When it comes to plasma, or the liquid part of blood, the blanket is always dramatically short. Thanks to Covid, the collection of plasma in 2022 had collapsed: approximately 850 thousand kilograms of plasma for the production of plasma-derived medicines collected, 20 thousand less than in 2021.

The main plasma-derived medicinal products include albumin, immunoglobulins, antithrombin, coagulation factor VIII, coagulation factor IX, coagulation factor VII, coagulation factor XIII, prothrombin complex concentrates, fibrinogen . These are often life-saving drugs for patients who need them.

Second preliminary data from the National Blood Center, in 2023, however, the trend was reversed. Indeed, there is talk of a record collection. At the same time, however, the long-awaited goal of self-sufficiency is receding. Why? The reasons are different.

The paradox

The paradox emerged during the second edition of «The Supply of Plasma-derived Medicinal Products in the Future of Europe», the international conference dedicated to plasma, sponsored by the Ministry of Health and organized by the National Blood Centre. As regards immunoglobulins, which is the main product of the plasma-derived medicines market, Italy in 2023 he reached a level of self-sufficiency of 62%, two percentage points lower than the previous year, when the self-sufficiency rate was 64%.

But the 2023 collection, with its 880 thousand kilos of plasmathe result of the generous donations of approximately 1.5 million donors, has achieved the highest levels ever for Italy.

The reasons for the shortage

What distanced our Parse from the strategic goal of autonomy in the field of plasma derivatives was a marked increase in the demand for immunoglobulinswhich went from around 104 grams per thousand inhabitants in 2022 to 108 in 2023. The preliminary data is partly mitigated by the increase in the level of self-sufficiency in albumin, another driving element of the market, which went from 72% in 2022 to 78% in 2023, thanks also to a drop in demand.

Italy, which is self-sufficient when it comes to the collection of blood cells redmust therefore resort to the international market to meet the demand for plasma derivatives and supplements medicines, also used in life-saving therapyproduced from plasma collected from voluntary, anonymous and unpaid donations.

A strategic problem

«The lack of self-sufficiency of plasma-derived medicines it remains a strategic problem for the national health system», reasons the director of the CNS, Vincenzo de Angelis. “The data, although still preliminary – continues De Angelis – confirm the need to increase collection through awareness-raising actions aimed at possible new donors, but this is not enough”.

«We will also need to rationalize demand, especially a product like immunoglobulins which is finding more and more applications at a therapeutic level. It is an objective on which we are already working with many Italian and European partners, because Covid has shown that, in particular and often unpredictable situations, the international market cannot always respond to the demand of our patients”.

Inappropriate prescribing and increased demand

On the same wavelength, Giovanni Musso, president of Trust me (Italian Federation of blood donor associations): « The importance of shapes as a strategic asset of the country must be clear to everyone. Because sometimes it is difficult to understand the use of plasma in medicine. We know well that it is used for many life-saving therapies, so it is essential. And it is also essential to understand that we still depend on foreign countries for a good percentage of these plasma derivatives.”

«Plasma collection has certainly increased – he continues -, so the campaigns to encourage collection even among donors have been useful. But self-sufficiency has dropped: what does this mean? The reasons could be linked to one inappropriate prescription of these drugs. I am not a doctor, but perhaps someone has not understood that plasma is not an infinite response but must be sipped. There could also be another reason the actual increase in patients who need it.”

We need a culture of donation

According to Musso, therefore, more must be done. Beyond ephemeral phenomena dictated by the emotion of the moment, such as the surge in donations recorded after the appeal to donate blood launched in October 2023 by Fedez, awareness campaigns are important but, even more so, «we need to create awareness, try to impact the community through more structural action, I would almost say civic education.”

For some time, with the increasing aging of the population, the alarm has been raised about the lack of generational turnover among donors. Every year a percentage of donors are lost due to reaching the age limit. Young people must compensate for this lossotherwise the donor population is destined to decline.

«In less than 10 years, this problem will explode and we could also risk non-sufficiency in red blood cell supplies”, explains the president of Fidas. Not only. It is also necessary to “publicize” plasma donation better and more, which is somehow considered “Series B” even by those who donate. Yes because it may sound strange but Even among active donors, not everyone is willing to donate plasma, in addition to red and white blood cells. «Instead, it would be enough for every active donor to make at least one donation of plasma to reach 70-80% self-sufficiency», underlines Musso.

The Fidas proposal: blood donation included in school textbooks

For this reason, last December, a delegation from Fidas presented to the Undersecretary for Education, the Honorable Paola Frassinetti, a proposal for blood donation to be included in school textbooks. «We need to create a true culture of giving – adds Musso -. And this must start from the first years of education.”

«A School of Gift» Competition

To encourage the spread of the message of blood donation, in the next National Congress, with the theme “The drop that makes life flourish again”, which will be held on 17 and 18 May in San Remo, Fidas will reward the schools that participated in the «A School of Gift» competition, initiative which aims to introduce young students to the world of donating blood and blood components to protect the health of patients and to promote the dissemination of knowledge, even among the youngest, of an important act of civic sense, a gesture that we can all do to take care of those who face rare and less rare pathologies.

Plasma donation: what is it

AND a withdrawal made via a device (cell separator) which immediately separates the corpuscular part, i.e. red and white blood cells and platelets, from the liquid component which is collected in a bag of approximately 600-700 ml. The corpuscular part is reinfused into the donor. The volume of liquid that is removed with the donation is reconstituted thanks to natural recovery mechanisms, the infusion of physiological solution and the intake of liquids.

The production of drugs from national plasma

The plasma is delivered to the pharmaceutical industry where it will be used for produce life-saving medicines, the so-called plasma derivatives, such as immunoglobulins, albumin or coagulation factors. Medicines produced with donated plasma they are not used for commercial purposes; once the manufacturing process is finished, they are returned to the healthcare facilities of the Italian Regions and Autonomous Provinces. Plasma-derived drugs are distributed free of charge to patients who need them and any lots exceeding national needs are donated to countries in difficulty through international collaboration programs.

Who can donate

Despite the many fake news in circulation, blood and plasma donation is a life-saving and safe practice. It is open to all citizens who have a valid identity document. To be able to donate the following are required: age between 18 and 65 (for the first donation 60 years old, periodic donors can donate up to 70, subject to the consent of the selecting doctor); minimum body weight of 50 kilograms; good state of health.