diRuggiero Corcella
Preliminary data from the National Blood Center: in 2023, 880 thousand kilos of plasma were collected from 1.5 million donors. But the self-sufficiency of the drugs produced drops from 64 to 62%. There are various reasons, but more donations are needed
When it comes to plasma, or the liquid part of blood, the blanket is always dramatically short. Thanks to Covid, plasma collection had collapsed in 2022: around 850 thousand kilograms of plasma for the production of plasma-derived medicines were 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.
According to preliminary data from the National Blood Center, in 2023 the trend has 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, in 2023 Italy reached a level of self-sufficiency equal to 62%, two percentage points lower than the previous year, when the self-sufficiency rate was equal to at 64.
But the 2023 collection, with its 880 thousand kilos of plasma, the result of the generous donations of around 1.5 million donors, reached 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 sharp increase in the demand for immunoglobulins, which went from approximately 104 grams per thousand inhabitants in 2022 to 108 in 2023. The preliminary data is partly mitigated by the increase of the level of self-sufficiency in albumin, another driving force of the market, which went from 72% in 2022 to 78% in 2023, also thanks to a decline in demand.
Italy, which is self-sufficient when it comes to the collection of blood cells rossimust therefore resort to the international market to meet the demand for plasma derivatives and integrate medicines, also used in life-saving therapy, produced from plasma collected from voluntary, anonymous and unpaid donations.
A strategic problem
«The lack of self-sufficiency of plasma-derived medicines 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”.
«It will also be necessary to rationalize demand, especially for 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 (Italian Federation of blood donor associations): «The importance of plasma as a strategic asset for 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 an 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. Another reason could also be 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, trying 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 leakage, otherwise the donor population is destined to decline.
«In less than 10 years, this problem will explode and we could even 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, as well as 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 a proposal to the Undersecretary of Education, the Honorable Paola Frassinetti, 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 competition «A Scuola di Dono», an initiative that 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 of an important act of civic sense, even among the youngest, gesture that we can all make to take care of those facing rare and less rare pathologies.
Plasma donation: what is it
It is a sampling carried out using 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 supplied to the pharmaceutical industry where it will be used to produce life-saving medicines, so-called plasma derivatives, such as immunoglobulins, albumin or coagulation factors. Medicines produced with donated plasma 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 batches 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.
April 30, 2024
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