INFORMATION ONLY

Expanded Use of Solvent Detergent PlasmaCustomer Letter # 2022-28 2022-11-10

Dear Colleagues:

Further to customer letter 2022-18, below is information regarding our migration to pathogen reduced plasma. This initiative is part of our broader long-term commitment to introducing pathogen inactivation technology (PIT) to fresh blood products.

We will implement pathogen reduced plasma in two phases, with an aim to replace our current Frozen Plasma with pathogen-reduced plasma, pending Health Canada approval. Phase One involves the gradual transition from our current Frozen Plasma inventory to Octaplasma, Solvent Detergent (S/D) Treated Human Plasma Liquid: 200 mL, a Health Canada approved product and part of our current formulary. To support the transition, we will continue to have available an inventory of our current Frozen Plasma (approximately 20% of plasma issued at end of Phase One). Phase Two will entail process development and deployment of pathogen reduction technology to the remaining Frozen Plasma inventory using the Intercept Blood System for plasma, the same technology we are using on our platelets. By the end of Phase Two, our Frozen Plasma will be entirely replaced with pathogen-reduced frozen plasma and will comprise 20% of total plasma inventory.

See product monograph Octaplasma Solvent Detergent (S/D) Treated Human Plasma Liquid: 200 mL for a product description and more product details. Of note, this product is supplied in a standard volume of 200ml, whereas the mean volume of a unit of Frozen Plasma is 289ml.

On Friday October 21, 2022, we completed a series of stakeholder engagement meetings with transfusion medicine laboratory teams. These meetings provided valuable feedback and will be used to guide our implementation plan. Thank you to everyone who was able to attend.
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Key Dates
March 2023 – We expect all restrictions for Octaplasma™ to be lifted allowing for all hospitals to order for all patients by March 2023.

September 2023 – All hospitals will be expected to be ordering Octaplasma™ with at least 80% of plasma issues made up by Octaplasma™) by this date. This target will be guided by the experience of hospital customers as they transfuse more Octaplasma™ and will be dependent on the product manufacturer receiving Health Canada approval for 5-day post thaw expiry (anticipated by late fall/early winter 2022).

As previously mentioned above, pathogen reduction treatment of approximately 20% of our plasma collections is currently under development. Further details and timelines for the roll out of this product and the implementation plan will be shared in a future customer letter.

Ordering
More details regarding changes to how to order Octaplasma will be shared in future communications.

Educational Materials
To assist you during your implementation steps, we are developing a series of educational materials. These materials are nearing completion and will be available shortly. Once finalized, they will be posted on our Professional Education website; links will be provided in subsequent communication. These materials will include the following:

For hospital transfusion technical staff

• Product slide deck
• Frequently Asked Questions

For prescribers and transfusion service medical directors

• Clinical slide deck
• Frequently Asked Questions
• One-page clinical summary

For both audiences

• Update to Clinical Guide to Transfusion
• Publication for Professional Education website
• Solvent Detergent treated Plasma/Frozen Plasma comparison table

Packaging
Octaplasma is packaged in cases of 10 bags/units. Each bag/unit has an over-wrap of polyamide/polyethylene to protect the units during thawing.

Canadian Blood Services Frozen Plasma Octaplasma

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Laboratory Information Systems
If not already done, component codes should be created in your laboratory information system. Each product end label includes a lot number as well as a unique unit/bag tracking number. See attached previously shared information (2015) from the manufacturer.

NOTE: Please disregard statements in this attachment regarding blood group availability. This was relevant information in 2015 but is no longer valid in 2022. All ABO blood groups (O, A, B AB) will be available.

Thawing
See customer letter 2017-07 and this customer letter’s attachment Please share a copy of this customer letter with healthcare professionals at your hospital who might be interested in this information.

This customer letter can also be viewed at www.blood.ca in the “Hospitals Services” section. If you have questions about this letter, or if you require it in an accessible format, please contact your local hospital liaison specialist.

Sincerely,

Tanya Petraszko, MD FRCPC

Senior Medical Director, Medical, Laboratories and Stem Cell Services