Plasma collection in Canada: Stakeholder input a key part of an evidence-based approach


Wednesday, September 28, 2016

(OTTAWA) - As the national authority for and steward of the blood system in Canada, Canadian Blood Services continues to monitor and analyze the security of the supply of plasma needed to produce plasma protein products. The patients who benefit from these lifesaving products continue to be at the centre of our work. Canada has benefited from our ongoing analysis for many years, and we continue to assess the security of the plasma supply using an internationally recognized Risk-Based Decision-Making Framework.

This Alliance of Blood Operators Risk-Based Decision-Making framework was developed to improve blood sector decision-making, facilitate proportional responses to risk, ensure decisions are evidence-based, increase trust in investment decisions and allow for redirection of resources to improve effectiveness.

Can the U.S. plasma industry continue to meet growing national and global demands for plasma protein products? Does our reliance on the U.S. market make Canada vulnerable to a disruption in supply? Those are questions that we, and many others worldwide, are studying. Our analysis shows Canada’s and the world’s dependence on plasma from the United States is a considerable and growing risk. The demand for plasma products is rising. Advances in medicine are allowing health-care professionals to better diagnose patients, which can lead to an increased use of products. There are also a rising number of indications for plasma protein products. Finally, there are new markets — like China and India — where use is lower at the moment, but has the potential to increase; even a small percentage increase in those markets could have a significant impact.

Canadian Blood Services has determined the need to increase the amount of plasma we collect to manufacture products like immune globulin (Ig) to lower our dependence on foreign sources. That said, we will need to maintain a diversity of sources to continue to ensure a secure supply of plasma for Canadians. Other jurisdictions are also adjusting their plasma collection models.

Through our risk-based decision-making process, we are able to account for several factors, including risks, benefits, costs, ethical issues and stakeholder perspectives. As we develop and refine our plasma collection goals and plans, the process will include engaging our stakeholders. They include patients, donors, governments, and the health sector. We also want to create opportunities for Canadians to engage in this discussion. Starting this fall, we will be engaging our stakeholders in a variety of ways to ensure their perspectives – their voices – are heard and considered in our plans.

Plasma protein products such as immune globulin (Ig) help treat Canadians with immunological, neurological, hematological and other types of diseases. Plasma, just like whole blood, is a public resource that must be safeguarded for Canadians. As we work to determine how we will significantly increase the amount of plasma we collect over the next number of years, we are committed to making evidence-based decisions, working in true collaboration with our partners, and ensuring we maintain the trust we’ve worked so hard to earn from Canadians.

What is plasma?

Plasma is the protein-rich liquid in blood that helps other blood components circulate throughout your body. It supports your immune system and helps control excessive bleeding, which is why plasma donations are important to help treat bleeding disorders, liver diseases and cancer.

At Canadian Blood Services, we collect plasma either by separating it from whole blood after a whole blood donation, or by using a special collection process called apheresis. Apheresis is a medical technique in which the plasma portion of your blood is separated during donation, and all your red blood cells, white blood cells and platelets are returned to you.

Plasma is used both for transfusions and for fractionation, which processes plasma into a range of specialized proteins for therapeutic use.

  • Recovered plasma
    Recovered plasma is separated from whole blood and used in fractionated products such as albumin, immune globulin (Ig), and others to treat bleeding, immunodeficiency disorders and more.
     
  • Fresh frozen plasma
    Fresh frozen plasma is made from recovered plasma for transfusion only, and is used to treat patients with bleeding disorders, liver diseases and cancer. It is also used for bone marrow therapy.
     
  • Source plasma
    Source plasma is collected by apheresis and can be frozen for use as fresh frozen plasma or used for fractionation.

Plasma in Canada

Today, the amount of plasma we collect is only sufficient to manufacture about 17 per cent of Canada’s needs for immune globulin (Ig), the plasma protein products in highest demand by patients. The other 80+ per cent of the products we buy are made from plasma donated by paid donors in the United States. Without this U.S. system, which supplies about 65 per cent of the world’s plasma for manufacturing products like immune globulin (Ig), patients who depend on these drugs would not have ready access to the therapies they need.

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