Plasmavigilance: Source plasma joins the call to arms

Cho, Joseph H; Hiskey, Matthew

doi:10.1111/trf.16668

Cited by 3 publications

(5 citation statements)

References 16 publications

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“…25 These concerns are further compounded by the risk of adverse reactions from donation, with female donors being at higher risk than male donors. 26 Table 3 Thematic analysis of qualitative interviews with albumin prescribers…”

Section: Discussionmentioning

confidence: 99%

Improving appropriate use of intravenous albumin: results of a single-centre audit and multifaceted intervention

Forster,

Halls,

Allarakhia

et al. 2024

BMJ Open Qual

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BackgroundIntravenous albumin has limited indications supported by randomised controlled trials, yet it is often prescribed for indications not supported by evidence.AimTo reduce unnecessary transfusion of albumin.InterventionsUnder the leadership of a multidisciplinary quality improvement team, evidence-based recommendations were disseminated in tandem with a new electronic order set, an educational strategy, qualitative interviews with prescribers and a return policy change to reduce wastage.Implementation and evaluationInterventions were introduced in a staggered fashion. The primary outcome, appropriate use of albumin, was monitored and quantified using pre-intervention and post-intervention audits. Process measures included statistical process run charts of monthly usage of 5% and 25% albumin and wastage. Data on length of stay (hospital and intensive care), new inpatient starts on kidney replacement and mortality were collected as balancing measures.ResultsAppropriate albumin usage based on indication increased from 30% to 50% (p<0.0001). There was significantly less overall albumin usage in the post-intervention period compared with the pre-intervention period (negative coefficient, p<0.0001), driven by a major reduction in the utilisation of the 5% formulation (p<0.0001). Overall albumin usage was significantly lower in the post-intervention period, decreasing from 800 to 450 vials per month. The intervention resulted in significantly less wastage (negative coefficient, p=0.017). Mortality, length of stay and new starts on kidney replacement therapy remained constant throughout the study period.ConclusionImproved prescribing of albumin was achieved with a multifaceted approach. Substantial and sustained reductions in usage were achieved without negatively impacting patient-important outcomes. The estimated annual savings for the purchase cost of albumin was CAN $300 000. We provide a structured process for other organisations to optimise their use of albumin.

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Section: Discussionmentioning

confidence: 99%

Improving appropriate use of intravenous albumin: results of a single-centre audit and multifaceted intervention

Forster,

Halls,

Allarakhia

et al. 2024

BMJ Open Qual

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“…Results from the two completed studies showed that iron deficiency and anemia are not associated with SP donation and that adverse effects of plasmapheresis are low and are similar to whole blood donation. [24][25][26] Here we report the results of the most recent PPTA study of the cross-sectional associations between healthrelated quality of life and SP donation frequency. This study allowed us to contextualize the health of SP donors by making interpretations, relative to the general population, and to evaluate study hypotheses.…”

Section: Discussionmentioning

confidence: 99%

“…Considering that SP collection methods have changed since then (i.e., from manual to automated) and SP donor health is paramount to the industry, the PPTA is conducting a series of studies to assess SP donor health under the FDA‐approved frequencies and volumes. Results from the two completed studies showed that iron deficiency and anemia are not associated with SP donation and that adverse effects of plasmapheresis are low and are similar to whole blood donation 24–26 …”

Section: Discussionmentioning

confidence: 99%

Effects of donation frequency on U.S. source plasma donor health

Fransen,

Becker,

Hershman

et al. 2023

Transfusion

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BackgroundPlasma‐derived medicinal products (PDMPs) are essential, life‐saving medicines manufactured from plasma donated by healthy human volunteers. PDMPs are used to treat a range of rare, serious, and chronic conditions, often genetic in origin. Approximately 70% of the Source Plasma (SP) used for PDMP manufacturing comes from United States (US). The hypothesis of the study is that US donation frequency does not impair donor self‐reported functional health and well‐being.Study Design and MethodsA total of 5608 SP donors from 14 US SP centers were enrolled in a cross‐sectional study to assess self‐reported health related quality of life (HRQoL) and well‐being. By sex, donors were assigned to one of four groups, according to their frequency of SP donation in the 12 months before enrollment. The SF‐36v2® Health Survey (SF‐36v2) and a survey assessing the frequency of various health conditions that may be associated with impaired immune function over different time periods were used.ResultsThere were no statistically significant differences in SF‐36v2 scores between any of the donor frequency groups, compared with new donors after controlling for potential confounding and accounting for multiple comparisons among males and females. Cough, cold, occasional fatigue, and sore throat were the most reported health conditions or symptoms, but there was no clear difference among sex or frequency groups.DiscussionThe self‐reported data in this study support the hypothesis that compensated donations at US FDA permitted frequencies and volumes are consistent with maintaining donor health. Compared with the general population, SP donors have comparable or better health than the general population.

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“…Source plasma comprises more than 80% of the plasma fractionated in the US, totaling more than 53 million donations in 2019, with recovered plasma representing only 20%. The US currently collects approximately 70% of the world's supply, partly because the regulatory environment supports high‐frequency donations and pays donors for their time and incidental expenses 2 …”

Section: Introductionmentioning

confidence: 99%

“…The US currently collects approximately 70% of the world's supply, partly because the regulatory environment supports high-frequency donations and pays donors for their time and incidental expenses. 2 Patients who require therapies manufactured from human plasma rely on the donations of many individuals. The PDMP manufacturing process starts with the collection of human plasma from healthy donors.…”

Section: Introductionmentioning

confidence: 99%