In This Issue

• Spotlight on Ferric Derisomaltose
• ACC- Ambulatory Care Centre: Infusion/Treatment Clinic
• Newsboard
  • ORBCoN Fall (MHP) Symposium
• Upcoming Events
  • Register: CBS/ORBCoN Technical Dry Workshop
  • Register: 18th Annual Transfusion Medicine Webconference
  • Register: Transfusionists Talk: Transfusion Made Bloody Easy
  • UofT TM Rounds

Did you know?

Spotlight on Ferric Derisomaltose

Alanna Howell, RN
ONTraC Program Manager

The Global Health Burden 2019 Study estimated that there were 1.8 billion cases of anemia in the world and anemia accounted for 50.3 million years lived with disablility.¹ Iron deficiency is known to be the most common type of anemia.
For several decades intravenous (IV) iron  has been used as a successful treatment modality for iron deficiency and iron deficiency anemia (IDA). It is an option when oral iron is not effective or poorly tolerated or when there is a need to correct anemia rapidly. IV iron is used in various hospital specialty groups including cardiac, oncology, gastroenterology, gynecology and obstetrics. The use of IV iron has expanded in recent years and is now a part of perioperative patient blood management programs.
Earlier IV iron formulations were associated with serious reactions caused by a rapid iron release. In recent years newer formulations have come on the markets which are deemed to be safer. They contain carbohydrate cores which bind elemental iron more tightly resulting in a slower, controlled release and fewer reactions.² One of these newer formulations is ferric derisomaltose (Monoferric®) which was formerly known as iron isomaltoside 1000.  It is a third – generation IV iron compound. It allows for high dose infusion of up to 20 mg/kg or maximum of 1,500 mg administered as an infusion over 30 minutes or more in one visit versus multiple visits.  First introduced in Europe in 2009, it was approved by Health Canada in 2018.  The table below lists the indications and methods of administration for ferric derisomaltose in Canada.³ 

Ferric derisomaltose has shown good efficacy and safety in clinical trials. PROPOSE (N=351), FERWON-Nephro (N=1538), PROVIDE (N=511) and FERWON – IDA (N=1512) compared iron isomaltoside 1000 to iron sucrose in patients with IDA. All of these trials showed iron isomaltoside 1000 to be non-inferior to iron sucrose in raising and/or maintaining hemoglobin levels.^,4,5,6

The recommended total dose is typically between 1000 mg and 1500 mg. The dose may be calculated using the Ganzoni formula or by using a simplified table that can be found within the product monograph. The cost of ferric derisomaltose is $45 per mL leading to a drug cost of $450 for a 1000 mg course of therapy, comparable to a three dose course of Venofer, an iron sucrose. The list below shows various ways the cost of the drug may be covered for patients in the province of Ontario.

• Self pay
• Private Insurance – DIN #02477777
• Limited Use (LU) benefit funded through the Ontario Drug Benefit program The LU criteria is shown in the table below7:

• Canada Veterans Affairs formulary coverage as a standard benefit
• Government of Canada Non-Insured Health Benefit (NIHB) program as an open benefit

The use of ferric derisomaltose is becoming more popular. It provides a complete or near-complete replacement in a single infusion and is generally well tolerated. This results in improved convenience for the patient, shorter chair times, reduced number of infusions needed and a faster correction of anemia.

References

1. Safiri S, Kolahi AA, Noori M, Nejadghaderi SA, Karamzad N, Bragazzi NL, Sullman MJM, Abdollahi M, Collins GS, Kaufman JS, Grieger JA. Burden of anemia and its underlying causes in 204 countries and territories, 1990-2019: results from the Global Burden of Disease Study 2019. J Hematol Oncol. 2021 Nov 4;14(1):185. doi: 10.1186/s13045-021-01202-2.
2. Auerbach M, Macdougall IC. Safety of intravenous iron formulations: facts and folklore. Blood Transfus. 2014 Jul;12(3):296-300. doi: 10.2450/2014.0094-14..
3. Monoferric (ferric derisomaltose) Canadian Product Monograph Pharmacosmos A/S  Nov 2022.
4. Derwman, R. et al. A randomized trial of iron isomaltoside versus iron sucrose in patients with iron anemia. AmJHematol.92, 286-291 (2017)
5. Auerbach M. et al. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J. Hematol. 94, 1007 -1014 (2019)
6. CADTH Clinical Review Report: Iron Isomaltoside 1000 ( Monoferric): Pharmacosmos A/S): Indication: For the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy (May 2020)
7. Ontario Drug Benefit Formulary /Comparative Drug Benefit.  Available online at https://www.formulary.health.gov.on.ca/formulary/

ACC- Ambulatory Care Centre: Infusion/Treatment Clinic

Leslie Chambers, RN BScN, Patient Care Manager Operating Room, Day Surgery, Chemotherapy and Specialist Clinics, St. Joseph’s General Hospital Elliot Lake

The pandemic brought many opportunities and changes to our care delivery model. Some issues which we faced were quite challenging, and others encouraged us to seek solutions and alternatives to continue provision of care to our patients.
At St. Joseph’s General Hospital Elliot Lake (SJGHEL) patients requiring infusion therapy were historically seen and treated in our Emergency Department (ED). With pandemic protocols, overcapacity, and ED pressures the ED was no longer the appropriate location for these scheduled outpatients to attend. Conversely our Day Surgery Department experienced a decrease in patients due to Ministry enforced reductions and ramp downs of surgical procedures, leaving us with staff available to provide this service.
We developed a pilot project to treat infusion patients on our day surgery unit. Our patient population included those receiving non urgent, Remicade, Simponi, Entyvio, IVIG, iron  infusions and blood transfusions. We were fortunate at the onset to utilize staff that had been accommodated to work outside of acute care areas. We were able to offer this service 5 days per week. 
As Surgical recovery regained increasing activity, we were committed to continuing this care delivery model as the feedback from the Emergency Department and the patients was overwhelmingly positive.  Our evaluation demonstrated improved appointment coordination, significant decrease in cancellations due to other factors (common in the ED), as well as the utilization of order sets for iron, blood components and products. The improved coordination and order set implementation enhanced fiscal accountability ensuring, where appropriate, patient medications were provided through either private insurance or EAP funding models decreasing the cost to the organization. 

The pilot ran for 8 months, due to the demonstrated success we endeavoured to seek additional funding to keep this clinic open 5 days per week. However, due to additional pressures, the organization could not commit to the additional funding. The nursing team advocated and was determined to keep the infusion clinic functioning, citing the clinic had improved our patient experience. As a team we evaluated our volumes and the hours of work per treatment were calculated for workload and feasibility evaluation. We developed a plan using Day Surgery Nursing resources currently in place to ensure that we could continue this service 3 days per week, Tuesday through Thursday. Two part time RNs committed to oversee the bookings and coordinate resources, which included occasional time shifting of hours to allow for working patients to attend appointments at non traditional times after 4 PM.  
This 3-day model of care has been successfully delivering care to patients for 6 months. We have worked collaboratively with our laboratory department to add services such as therapeutic phlebotomy and fluid replacement patients. The infusion clinic has also addressed a lack of service for outpatient oncology patients that are non emergent but require urgent transfusion in a safer environment than an overcrowded ED. We have achieved our goals of improving the patient experience, inspiring employees to be engaged in quality care delivery improvement and demonstrating leadership in our commitment to patient care.

Upcoming Events

CBS/ORBCoN Technical Dry Workshop

18th Annual TM Webconference

Transfusionists Talk: Transfusion Made Bloody Easy

UofT TM Rounds

March 23, 2023 @12pm-1pm

Virtual – Whole Blood Debate by Dr. Nick Crombie, Dr. Mark Yazer and Dr. Jeannie Callum – moderator

Attachment(s)

dans ce rapport

• Pleins feux sur le dérisomaltose ferrique
• CSA – Centre de soins ambulatoires : clinique de perfusion/traitement
• Newsboard
  • ORBCoN Fall (MHP) Symposium
• Upcoming Events
  • Register: CBS/ORBCoN Technical Dry Workshop
  • Register: 18th Annual Transfusion Medicine Webconference
  • Register: Transfusionists Talk: Transfusion Made Bloody Easy
  • UofT TM Rounds

Did you know?

Pleins feux sur le dérisomaltose ferrique

Alanna Howell, IA
Gestionnaire du programme ONTraC

L’étude Global Health Burden de 2019 a estimé qu’il y avait 1,8 milliard de cas d’anémie au monde, ce qui se traduisait par 50,3 millions d’années vécues avec une incapacité¹. L’anémie ferriprive est le type d’anémie le plus courant.
For several decades intravenous (IV) iron has been used as a successful treatment modality for iron deficiency and iron deficiency anemia (IDA). It is an option when oral iron is not effective or poorly tolerated or when there is a need to correct anemia rapidly. IV iron is used in various hospital specialty groups including cardiac, oncology, gastroenterology, gynecology and obstetrics. The use of IV iron has expanded in recent years and is now a part of perioperative patient blood management programs.
Auparavant, les formulations de fer intraveineux étaient associées à de graves réactions attribuables à une libération rapide du fer. Depuis quelques années, de nouvelles formulations jugées plus sûres sont apparues sur le marché. Elles contiennent des noyaux d’hydrate de carbone qui lient plus étroitement le fer élémentaire, ce qui permet une libération plus lente et mieux contrôlée tout en réduisant les réactions². Une de ces nouvelles formulations est le dérisomaltose ferrique (Monoferric®), auparavant connu sous le nom d’isomaltoside de fer 1000. C’est un composé de fer i.v. de troisième génération qui permet une perfusion à forte dose, allant jusqu’à 20 mg/kg ou un maximum de 1500 mg administré en 30 minutes ou plus en une seule visite comparativement à plusieurs visites. D’abord lancé en Europe en 2009, il a été approuvé par Santé Canada en 2018. Le tableau ci-dessous présente les indications et les modes d’administration du dérisomaltose ferrique au Canada³.

Dans les essais cliniques, le dérisomaltose ferrique a montré une bonne efficacité et une bonne innocuité. Les essais PROPOSE (N=351), FERWON-Nephro (N=1538), PROVIDE (N=511) et FERWON-IDA (N=1512) ont comparé l’isomaltoside de fer 1000 au fer sucrose dans des cas d’anémie ferriprive. Tous ces essais ont démontré que l’isomaltoside de fer 1000 n’était pas inférieur au fer sucrose pour augmenter ou maintenir le taux d’hémoglobine4,5,6. ^,4,5,6

La dose totale recommandée se situe généralement entre 1000 mg et 1500 mg. La dose peut se calculer à l’aide de la formule de Ganzoni ou en consultant le tableau simplifié qui se trouve dans la monographie du produit. Le dérisomaltose ferrique coûte 45 $ per mL, donc 450 $ pour un traitement de 1000 mg, ce qui se compare à un traitement de trois doses de Venofer, un fer sucrose. Voici une liste de diverses possibilités de couverture du prix du médicament en Ontario.

• Paiement par le patient
• Assurance privée – DIN #02477777
• Prestation de médicament à usage limité (LU) couvert par le programme Programme des médicaments de l’Ontario. Les critères qui s’appliquent sont décrits dans le tableau suivant7 :

• Couverture du formulaire d’Anciens combattants Canada en tant que prestation courante
• Programme des Services de santé non assurés (SSNA) du gouvernement du Canada pour un médicament couvert

L’emploi de dérisomaltose ferrique gagne en popularité. Il permet de combler tous les besoins ou presque en une seule perfusion et il est habituellement bien toléré. Il est plus pratique pour le patient et se traduit par un temps moindre en traitement, un nombre moindre de perfusions et une correction plus rapide de l’anémie.

Références

1. Safiri S, Kolahi AA, Noori M, Nejadghaderi SA, Karamzad N, Bragazzi NL, Sullman MJM, Abdollahi M, Collins GS, Kaufman JS, Grieger JA. Burden of anemia and its underlying causes in 204 countries and territories, 1990-2019: results from the Global Burden of Disease Study 2019. J Hematol Oncol. 4 nov 2021;14(1):185. DOI:10.1186/s13045-021-01202-2.
2. Auerbach M, Macdougall IC. Safety of intravenous iron formulations: facts and folklore. Blood Transfus. Juillet 2014;12(3):296-300. DOI : 10.2450/2014.0094-14.
3. Monographie canadienne de Monoferric (dérisomaltose ferrique. Pharmacosmos A/S Novembre 2022.
4. Derwman, R. et coll. A randomized trial of iron isomaltoside versus iron sucrose in patients with iron anemia. AmJHematol. 92, 286-291 (2017)
5. Auerbach M. et coll. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J. Hematol. 94, 1007 -1014 (2019) 94, 1007 -1014 (2019)
6. CADTH Clinical Review Report: Iron Isomaltoside 1000 ( Monoferric): Pharmacosmos A/S) : Indication: For the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy (Mai 2020)
7. 7. Ontario Drug Benefit Formulary /Comparative Drug Benefit. En ligne : https://www.formulary.health.gov.on.ca/formulary/

CSA – Centre de soins ambulatoires : clinique de perfusion/traitement

Leslie Chambers, IA BScN, directrice, Soins aux patients au bloc opératoire, unités de chirurgie de jour, de chimiothérapie et de traitements spécialisés, Hôpital général St. Joseph Elliot Lake

La pandémie a suscité bien des possibilités et des changements à notre modèle de prestation de soins. Nous avons été confrontés à certains problèmes très difficiles, alors que d’autres nous ont incités à trouver des solutions de rechange pour continuer à fournir des soins à nos patients.
À l’Hôpital général St. Joseph d’Elliot Lake (SJGHEL), nous avions l’habitude de voir à l’Urgence les patients qui avaient besoin de traitements administrés par transfusion. En raison des protocoles de pandémie, de la surfréquentation et des pressions exercées sur les Urgences, l’endroit ne convenait plus pour accueillir ces patients externes qui venaient sur rendez-vous. À l’inverse, notre département de chirurgie de jour a connu une baisse d’achalandage en raison des diminutions imposées par le Ministère et de la baisse des interventions chirurgicales, ce qui nous a laissé du personnel libre pour offrir ce service.
Nous avons mis en place un projet pilote pour traiter les patients qui avaient besoin de perfusions dans notre unité de chirurgie de jour. Notre population regroupait les patients qui recevaient des perfusions non urgentes de Remicade, de Simponi, d’Entyvio, d’IgIV ou de fer, ou encore des transfusions sanguines. Nous avons eu la chance au départ de pouvoir compter sur du personnel qui avait été affecté hors des zones de soins aigus. Nous avons pu offrir ce service 5 jours par semaine.
Quand les chirurgies ont repris en plus grand nombre, nous voulions continuer à offrir ce modèle de prestation de soins, car les réactions tant de l’Urgence que des patients avaient été extrêmement positives. Notre évaluation a conclu à une meilleure coordination des rendez-vous, à une nette baisse des annulations en raison d’autres facteurs (ce qui était fréquent à l’Urgence) ainsi qu’au recours à des ensembles d’ordonnances pour le fer, de même que pour les composants et produits sanguins. Cette meilleure coordination et le recours à des ensembles d’ordonnances a eu un impact financier positif en garantissant que les médicaments étaient payés, le cas échéant, par une assurance privée des patients ou des modèles de financement du Programme d’accès exceptionnel, ce qui a réduit les dépenses organisationnelles.

Le projet pilote a duré huit (8) mois. En raison de son succès, nous avons tenté d’obtenir des fonds supplémentaires pour que la clinique reste ouverte cinq (5) jours par semaine. Cependant, à cause de pressions supplémentaires, l’organisation n’a pu dégager les fonds. Avec détermination, l’équipe de soins infirmiers a plaidé en faveur du maintien de la clinique de perfusion, affirmant que cette clinique avait amélioré l’expérience de nos patients. En équipe, nous avons calculé nos volumes et le temps de travail par traitement pour évaluer la charge de travail et la faisabilité. Nous avons élaboré un plan en utilisant les ressources en soins infirmiers de chirurgie de jour actuellement en place pour assurer le maintien de ce service trois (3) jours par semaine, du mardi au jeudi. Deux infirmières autorisées à temps partiel se sont engagées à superviser les réservations et à coordonner les ressources, y compris de décaler parfois les heures pour permettre aux patients qui travaillent de se rendre à leur rendez-vous à des heures non traditionnelles après 16 heures.
Grâce à ce modèle de soins de trois (3) jours, nous avons pu fournir avec succès des soins aux patients pendant six mois. Nous avons travaillé en collaboration avec notre service de laboratoire pour ajouter des services, notamment la phlébotomie thérapeutique et le remplacement liquidien. La clinique de perfusion a aussi comblé un manque de service pour les patients externes connus en oncologie qui ont un besoin urgent de transfusion dans un milieu plus sûr qu’une salle d’urgence bondée. Nous avons atteint nos objectifs d’améliorer l’expérience des patients, d’inciter le personnel à participer à l’amélioration de la prestation de soin de qualité et de faire preuve de leadership dans notre engagement envers les soins aux patients.

Upcoming Events

CBS/ORBCoN Technical Dry Workshop

18th Annual TM Webconference

Transfusionists Talk: Transfusion Made Bloody Easy

UofT TM Rounds

March 23, 2023 @12pm-1pm

Virtual – Whole Blood Debate by Dr. Nick Crombie, Dr. Mark Yazer and Dr. Jeannie Callum – moderator

Attachment(s)

Here’s one hospital’s experience with implementing the new pathogen reduced pooled platelet component

Attachment(s)

In This Issue

• The Elephant and Electric Touch:  Er as the 44^th Blood Group Antigen System
• A pathogen-reduced inventory at Canadian Blood Services with a focus on solvent detergent plasma
• Newsboard
  • Tech assessment
  • Register: Transfusionists Talk: Transfusion Made Bloody Easy
  • Register: Provincial Bedside Audit of Blood Administration
• Upcoming Events
  • UofT TM Round

The Elephant and Electric Touch:  Er as the 44^th Blood Group Antigen System

Dr. Christine M Cserti-Gazdewich,
Laboratory Medicine Program – UHN

The running joke is that our long and ever-expanding list of red cell surface antigens exists simply to create jobs for blood bankers.  The transfusion of red blood cells (RBCs) might seem to be the easiest feat on Earth if it happens 100 million times annually, though what the ubiquitous act fails to reveal is just how much “behind-the-scenes” work goes in to compatibility- and safety- assurance. Likewise, 140 million babies are born every year, many with blood types different from the birthing parent.  RBC rejection (in acute or delayed hemolytic reactions [HTRs], or in hemolytic disease of the fetus or newborn [HDFN]), occurs in less than 1 in every 1000 such encounters, giving the impression that human blood, in standard transfusion practice, mixes uneventfully enough. Those not as familiar with RBC surface marker diversity were therefore understandably surprised – despite Pandemic-driven enhancements in scientific literacy around antibodies, antigens, and “variants of concern” – to learn just how noisy and vulnerable the RBC can be in the crosshairs of the immune system.  We do not just express the ABO system (with its four possible blood types [A, B, AB, and O]), or a D type in the Weiner system (“positive” [present] or “negative” [absent]). We express more than 40 other systems, which bear over 340 antigens within those formal bounds, with the possibility of “orphans” in so-called collections and series.  Every act of transfusion or pregnancy permits us to see version-differences in shared molecules, or entirely different structures that we ourselves may lack, for an overall seroconversion rate of ~1-10%.  The vast majority of the time, we can identify what these antibodies are, but sometimes we are left concluding “unidentified specificities,” with most but not all of these being insignificant.     

The recent announcement¹ on Er, the 44^th system, was both a giant discovery and a re-shuffling of information in our ISBT tables.² Three different Er antibodies were originally listed in the 200 series (“collection 208”), beginning with the high-prevalence anti-Er(a) in 1982, followed by the antithetical anti-Er(b), and then anti-Er3 (with mild HTRs) in Er(a-b-) individuals. What it took to go from a collection to a system was a series of proofs that these antibodies were targeting facets of a common molecule encoded by a specific gene with immunogenic variant loci.  The Bristol group used state-of-the-art sequencing and gene-editing techniques to show that the PIEZO1 gene (on chromosome 16q24.3) – which encodes the Piezo1 mechanosensitive cation channel – was at the root.  Piezo1 is an enormous (>2000 amino acid, >30 transmembrane pass) molecule that forms a propeller-like trimer or tetramer, permitting Na⁺ or Ca²⁺ (and thus water) influx with membrane pressurization. It is expressed across Kingdoms (from bacteria to mammals) and across tissues (from RBCs to endothelial cells and hollow organs [lungs, colon, kidneys, and bladder]). The discovery work behind this important class of master-sensors was recognized in the 2021 Nobel Prize.³ 

The Bristol team studied the expression and activity of this “electric touch” molecule further, and added two more antibodies to the list: anti-Er4 and anti-Er5, noteworthy for the sequelae of lethal HDFN. 

Though the 13 other new systems identified in the last decade weren’t met with as much fanfare, several features set Er apart. Firstly, there are already five Er antibodies catalogued, and more expected, whereas 10 of the 13 other systems are marked by isoantibody formation alone in those lacking the carrier (ie- a presence vs absence situation, rather than alloimmunization fodder from what appears to be a highly polymorphic gene). Secondly, Er antibodies have occurred in people not from a single consanguineous founder group, but from places as far as Mexico, Germany, Kuwait, and Zimbabwe, ie- resisting the mold of other geoancestry-typical antibodies. Thirdly, a host of other Piezo1 mutations are known to produce disease states, such as the gain-of-function (slow de-activation) autosomal dominant mutation behind the malaria-protective state of dehydrated hereditary stomatocytosis (AD DHS), or the homozygous autosomal recessive loss-of-function state of generalized lymphatic dysplasia with non-immune hydrops fetalis.  Knowing this molecule means knowing more about biology and disease. Fourthly, this molecule is present in a much lower membrane copy number than other RBC antigen systems, illustrating that target load is not a predictor of significance.     
Though to us, the updated taxonomy on known and new antibodies does not change our practice overnight, a “system” status arguably earns a place of greater priority. For decades, disparate groups of biochemists and serologists saw only the separate parts of an elephant, and now the elephant is whole. Modern laboratory techniques may help shepherd the remaining orphan antigens into the systems of future news stories, and aid in the development of reference laboratory tools and more tailored blood inventories.  Charged as we are with providing the right blood to the right patient, we now know more about why this might be hard in some rare cases, and how to go about getting the blood care mission accomplished.    

References of Interest:

1. The timeline:  On Saturday September 24^th 2022, the Bristol School of Biochemistry and the UK NHSBT’s International Blood Group Reference Laboratory (IBGRL) issued a press-release on the discovery of Er, the 44^th blood group antigen system. The scientific paper was accepted for publication by Blood on Monday, August 15^th and prepublished online a month later on Tuesday, September 20^th. The story gained traction on social media and on evening news broadcasts around the world throughout the month of October 2022.  (eg. https://toronto.citynews.ca/video/2022/10/16/scientists-discover-new-blood-group-er/)
   The article came out in print as a Plenary Paper on Thursday January 12^th 2023 (full reference:Karamatic Crew V, Tilley LA, Satchwell TJ, AlSubhi SA, Jones B, Spring FA, et al. Missense mutations in PIEZO1, which encodes the Piezo1 mechanosensor protein, define Er red blood cell antigens. Blood. 2023; 141(2):135-46.
   https://doi.org/10.1182/blood.2022016504, PubMed PMID: 36122374), with an accompanying podcast: https://ashpublications.org/blood/pages/blood_podcast_s5ep2
2. The ISBT’s Red Cell Immunogenetics and Blood Group Terminology Working Party’s website (https://www.isbtweb.org/isbt-working-parties/rcibgt.html) provides updated tables on antigens within the systems and collections (the 200 series [not meeting criteria for systems], and the subsets of the 700 series [low frequency antigens, <1%] and the 900 series [high frequency antigens, >99%]).  Er now has its own listing: https://www.isbtweb.org/resource/044er.html
3. The 2021 Nobel Prize in Physiology or Medicine:  for David Julius and Ardem Patapoutian, and their discoveries of receptors for temperature and touch.  https://www.nobelprize.org/prizes/medicine/2021/press-release/

A pathogen-reduced inventory at Canadian Blood Services with a focus on solvent detergent plasma

Kathryn Webert, MSc, MD, FRCPC
Medical Director and Special Advisor
Canadian Blood Services

To provide an additional layer of product safety, Canadian Blood Services aims to introduce pathogen-reduced components and products, wherever possible (Figure 1). Our journey towards a pathogen-reduced inventory began in January 2022, when Canadian Blood Services began a staggered implementation of pathogen-reduced platelets.

In March 2023, the transition to pathogen-reduced plasma will begin with the widespread implementation of Octaplasma, a solvent detergent (S/D) treated plasma.  In addition, implementation of another type of pathogen-reduced plasma, to be collected and manufactured by Canadian Blood Services using a different pathogen-inactivation technology and made available alongside S/D plasma, is tentatively planned for late 2024/25. Ultimately, it is expected that approximately 80% of plasma use will consist of S/D plasma and 20% will consist of Canadian Blood Services collected pathogen-reduced plasma. By 2025, the goal is for most platelets and plasma for transfusion to be pathogen-reduced.

Octaplasma is the commercial name for a pathogen-reduced form of frozen plasma manufactured by Octapharma. Octaplasma has been available only for special patient populations, but this will change as of March 2023, when it becomes available to all patients. Making it available to all patients is the most timely and cost-effective path towards a pathogen-reduced plasma supply. 

When Octaplasma is manufactured, plasma from hundreds of donations is pooled. This step reduces antibodies that may be present in the plasma pool through dilution. The pooled plasma then undergoes sterile filtration steps resulting in the removal of leukocytes, as well as prions, parasites, and viruses. The plasma is treated with a combination of 1% tri(nbutyl)-phosphate, or TNBP, and 1% octoxynol. The detergent, octoxynol, interrupts the interactions between the molecules in viruses’ lipid coatings. Most enveloped viruses cannot exist without their lipid coating, so they are destroyed when exposed to these detergents. The solvent, TNBP, helps the reaction between the lipid coat and the detergent to happen more rapidly. The solvent and detergent reagents are removed by castor oil extraction (removes TNBP) and solid phase extraction (removes octoxynol). The plasma is then run through an affinity ligand resin column which specifically removes prion proteins. This step is considered effective for removing the infectious agent that causes variant Creutzfeldt-Jakob disease (vCJD) if present. The final product is packaged into blood bags with a standardized unit volume of 200 mL and frozen.

There are many benefits of S/D treatment: it reduces the residual risk of transfusion-transmitted infections that remain after donor screening and donation testing and reduces the risk of emerging or unknown pathogens that can be transmitted during transfusion to a patient. In addition, the literature suggests that S/D plasma may be associated with a decreased risk of adverse reactions, including allergic reactions and transfusion related acute lung injury (TRALI).^1-5 The use of Octaplasma also benefits the blood system as it results in increased Canadian plasma available for fractionation.

On March 27, 2023, changes to the S/D plasma ordering process will be implemented, which will allow hospitals to order Octaplasma for all patients. By September 2023, all hospitals will be expected to order Octaplasma, with at least 80% of their plasma issues made up by Octaplasma by this date. This percent target will be guided by the experience of hospital customers as they transfuse more Octaplasma.
To assist hospitals during implementation steps, Canadian Blood Services is developing a series of educational materials which will be posted on our professional education website. Octapharma will also be making resources available.
Please contact Octapharma with any questions about Octaplasma and your local Hospital Liaison Specialist with any questions about Canadian Blood Services and plasma. Always refer to the Product Monograph for up-to-date information.⁶

References

1. Saadah NH et al. Transition from fresh frozen plasma to solvent/detergent plasma in the Netherlands: comparing clinical use and transfusion reaction risks. Haematologica 105:1158-65 (2020).
2. Liumbruno GM and Franchini M. Solvent/detergent plasma: pharmaceutical characteristics and clinical experience. J Thromb Thrombolysis 39:118-28 (2015). 
3. McGonigle AM et al. Solvent detergent treated pooled plasma and reduction of allergic transfusion reactions. Transfusion; 60:54-61 (2020). 
4. Klanderman RB et al. Reported transfusion-related acute lung injury associated with solvent/detergent plasma – A case series. Transfusion; 62: 594-99 (2022).
5. Sachs UJ et al. White blood cell-reactive antibodies are undetectable in solvent/detergent plasma. Transfusion; 45:1628-1631 (2005).
6. Octapharma. Octaplasma Product Monograph. October 21, 2022. Accessed at: https://www.octapharma.ca/en/therapies/product-overview

Newsboard

ORBCoN Tech Assessment

The ORBCoN Technologist Assessment program is now available on the new ORBCoN Learning Management System (LMS) and Surge Learning platforms.
A communication has been issued with instructions to provide site administrator information for access to the ORBCoN LMS and guidance for current Surge Learning clients.
If you have any questions or have not received the communication please reach out to alison.wendt@sunnybrook.ca

Provincial Bedside Audit of Blood Administration

Register: Transfusionists Talk: Transfusion Made Bloody Easy

Save the Date: 18th Annual TM Conference

Featured Resources

Frozen Plasma Toolkit

Upcoming Events

UofT TM Rounds

February 23, 2023 @12pm-1pm

ICTMG Behaviour change by Dr. Fabina Lorencatto & Dr. Justin Presseau

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Introduction 00:00 to 00:56
Demographics 00:56 to 02:23
Pre-Transfusion Checks – Transfusionist 02:24 to 03:58
Pre-Transfusion Checks – Transfusion Service 03:59 to 04:58
Transfusion 04:59 to 05:27
Patient Identification Checks 05:28 to 06:31
Component Checks 06:32 to 11:05
Procedure Checks 11:06 to 14:42
Post-Transfusion 14:43 to 18:24
Summary 18:25 to 19:08
If Questions, Contact 19:09 to 19:35

Attachment(s)

Introduction 00:00 to 01:04
Demographics 01:05 to 02:40
Pre-Transfusion Checks – Transfusionist 02:41 to 04:15
Pre-Transfusion Checks – Transfusion Service 04:16 to 04:59
Transfusion 05:00 to 05:25
Patient Identification Checks 05:26 to 06:41
Product Checks 06:42 to 09:22
Procedure Checks 09:23 to 13:16
Post-Transfusion 13:17 to 19:18
Summary 19:19 to 19:57
If Questions, Contact 19:58 to 20:24

Attachment(s)