Pharmacologic and pharmacokinetic factors in blood donation: A risk-based deferral framework proposal.

Pharmacologic and pharmacokinetic factors in blood donation: A risk-based deferral framework proposal.

Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects

Efforts to ensure donor and recipient safety have reduced the population of eligible voluntary blood donors. The current method for determining eligible blood donors in a population using only age as the criterion for excluding donors poorly reflects the large constellation of factors known to cause donor deferrals. An epidemiologic model has been developed to determine the prevalence of donor exclusions and thus improve the estimate of total eligible blood donors in the nation. Epidemiologic databases were selected to enumerate the population prevalence of 31 donor exclusionary factors which correspond to the AABB standards. Prevalence data were adjusted for age, duration of exclusion, and comorbidities. This method yields the number of excluded individuals to calculate the number of eligible blood donors. The conventional method of calculating eligible donors indicates that there are approximately 177 million eligible blood donors in the US population. This study indicates that this method erroneously includes 66 million individuals who are ineligible due to known exclusionary factors. Only 111 million individuals in the US population are eligible to donate blood. The conventional method of determining eligible blood donors overestimates eligible donor prevalence by approximately 59 percent (111 million eligible individual blood donors rather than 177 million eligible individuals). It is recommended that a method similar to the one described in this study be utilized to additionally exclude potential donors not meeting AABB donation standards to improve accuracy of eligible blood donor estimations.

Following FDA guidance, US blood collectors changed donor deferral for men who have sex with men (MSM) from indefinite to a 12 month deferral in 2016 (12 m), and for MSM and several other exposure risks to 3 month deferrals in 2020 (3 m). We evaluated first-time donor (FTD) HIV incidence and demographics during these periods. We estimated cross-sectional HIV incidence and incidence rate differences in FTD based on routine donation nucleic acid testing (NAT) and serology with additional limiting antigen (LAg)-Avidity immunoassay and viral load testing. We estimated incidence in the two policy periods (12 and 3 m), incidence trends in two-year intervals between 2015 and 2023, and used multivariable Poisson regression to assess demographic correlates of incident infection. HIV incidence in FTD during the 12 m deferral period was 2.82 infections/105 person-years (PY) [95% CI: 2.12, 3.67] and during the 3 m deferral period, it was 1.88/105 PY (95% CI: 1.18, 2.67), a statistically significant decline (p < .05). Over the period 2015-2023, incidence was stable. Male sex, younger age, Black or African American race, Hispanic ethnicity, and residence in the South were associated with incident infection in regression analysis, but the time-based deferral policy periods were not. HIV incidence in FTD did not increase between 2015 and 2023. An overall decline in HIV incidence in the 3 m deferral period compared with the 12 m deferral period was evident. These results provide no indication of an increased residual risk of transfusion-transmitted HIV from FTD in the United States with the reduced deferral periods.

BackgroundResearchers and activists have long called for changes to blood donation policies to end what is frequently framed as unjustified bans or deferral periods for men who have sex with men (MSM). Since 2016, in Canada, a man had to be abstinent from all sexual contact (anal or oral sex) with other men for at least 12 months in order to be an eligible blood donor. As of June 3, 2019, this deferral period was reduced to 3 months.MethodsTo better understand the acceptance of existing deferral policies and possible future policy, we conducted 47 in-depth interviews with a demographically diverse sample of gay, bisexual, queer, and other men who have sex with men (GBM) in Canada’s three largest cities: Vancouver, (n = 17), Toronto (n = 15), and Montreal (n = 15). Interviews were coded in NVivo 11 following an inductive thematic analysis. We focus on men’s preferred policy directions and their opinions about a policy change proposed by Canada’s blood operators: a 3-month deferral for all sexual activity between men. We interviewed GBM approximately one-year before this new deferral policy was approved by Health Canada.ResultsMost participants were opposed to any deferral period in relation to MSM-specific sexual activity. A fair and safe policy was one that was the “same for everyone” and included screening for several risk factors during the blood donation process with no categorical exclusion of all sexually active MSM. Participants believed that multiple “gender blind” and HIV testing-related strategies could be integrated into the blood donation process. These preferences for a move away from MSM-specific exclusions aligned with their opinions concerning the possible change to a 3-month MSM deferral, for which participants shared three overarching perspectives: (1) step in the right direction; (2) ambivalence and uncertainty; and (3) not an improvement.ConclusionA predominant assertion was that a change from a 12-month to a 3-month deferral period would not resolve the fundamental issues of fairness and equity affecting blood screening practices for GBM in Canada. Many participants believed that blood donation policy should be based on more up-to-date scientific evidence concerning risk factor assessment and HIV testing.

&lt;p&gt;Background: Researchers and activists have long called for changes to blood donation policies to end what is frequently framed as unjustified bans or deferral periods for men who have sex with men (MSM). Since 2016, in Canada, a man had to be abstinent from all sexual contact (anal or oral sex) with other men for at least 12 months in order to be an eligible blood donor. As of June 3, 2019, this deferral period was reduced to 3 months.&lt;/p&gt; &lt;p&gt;Methods: To better understand the acceptance of existing deferral policies and possible future policy, we conducted 47 in-depth interviews with a demographically diverse sample of gay, bisexual, queer, and other men who have sex with men (GBM) in Canada’s three largest cities: Vancouver, (&lt;em&gt;n&lt;/em&gt; = 17), Toronto (&lt;em&gt;n&lt;/em&gt; = 15), and Montreal (&lt;em&gt;n&lt;/em&gt; = 15). Interviews were coded in NVivo 11 following an inductive thematic analysis. We focus on men’s preferred policy directions and their opinions about a policy change proposed by Canada’s blood operators: &lt;em&gt;a 3-month deferral for all sexual activity between men.&lt;/em&gt; We interviewed GBM approximately one-year before this new deferral policy was approved by Health Canada.&lt;/p&gt; &lt;p&gt;Results: Most participants were opposed to any deferral period in relation to MSM-specific sexual activity. A fair and safe policy was one that was the “same for everyone” and included screening for several risk factors during the blood donation process with no categorical exclusion of all sexually active MSM. Participants believed that multiple “gender blind” and HIV testing-related strategies could be integrated into the blood donation process. These preferences for a move away from MSM-specific exclusions aligned with their opinions concerning the possible change to a 3-month MSM deferral, for which participants shared three overarching perspectives: (1) &lt;em&gt;step in the right direction&lt;/em&gt;; (2) &lt;em&gt;ambivalence and uncertainty&lt;/em&gt;; and (3) &lt;em&gt;not an improvement.&lt;/em&gt;&lt;/p&gt; &lt;p&gt;Conclusion: A predominant assertion was that a change from a 12-month to a 3-month deferral period would not resolve the fundamental issues of fairness and equity affecting blood screening practices for GBM in Canada. Many participants believed that blood donation policy should be based on more up-to-date scientific evidence concerning risk factor assessment and HIV testing.&lt;/p&gt;

&lt;p&gt;Background: Researchers and activists have long called for changes to blood donation policies to end what is frequently framed as unjustified bans or deferral periods for men who have sex with men (MSM). Since 2016, in Canada, a man had to be abstinent from all sexual contact (anal or oral sex) with other men for at least 12 months in order to be an eligible blood donor. As of June 3, 2019, this deferral period was reduced to 3 months.&lt;/p&gt; &lt;p&gt;Methods: To better understand the acceptance of existing deferral policies and possible future policy, we conducted 47 in-depth interviews with a demographically diverse sample of gay, bisexual, queer, and other men who have sex with men (GBM) in Canada’s three largest cities: Vancouver, (&lt;em&gt;n&lt;/em&gt; = 17), Toronto (&lt;em&gt;n&lt;/em&gt; = 15), and Montreal (&lt;em&gt;n&lt;/em&gt; = 15). Interviews were coded in NVivo 11 following an inductive thematic analysis. We focus on men’s preferred policy directions and their opinions about a policy change proposed by Canada’s blood operators: &lt;em&gt;a 3-month deferral for all sexual activity between men.&lt;/em&gt; We interviewed GBM approximately one-year before this new deferral policy was approved by Health Canada.&lt;/p&gt; &lt;p&gt;Results: Most participants were opposed to any deferral period in relation to MSM-specific sexual activity. A fair and safe policy was one that was the “same for everyone” and included screening for several risk factors during the blood donation process with no categorical exclusion of all sexually active MSM. Participants believed that multiple “gender blind” and HIV testing-related strategies could be integrated into the blood donation process. These preferences for a move away from MSM-specific exclusions aligned with their opinions concerning the possible change to a 3-month MSM deferral, for which participants shared three overarching perspectives: (1) &lt;em&gt;step in the right direction&lt;/em&gt;; (2) &lt;em&gt;ambivalence and uncertainty&lt;/em&gt;; and (3) &lt;em&gt;not an improvement.&lt;/em&gt;&lt;/p&gt; &lt;p&gt;Conclusion: A predominant assertion was that a change from a 12-month to a 3-month deferral period would not resolve the fundamental issues of fairness and equity affecting blood screening practices for GBM in Canada. Many participants believed that blood donation policy should be based on more up-to-date scientific evidence concerning risk factor assessment and HIV testing.&lt;/p&gt;

&lt;p&gt;Background&lt;/p&gt; &lt;p&gt;Researchers and activists have long called for changes to blood donation policies to end what is frequently framed as unjustified bans or deferral periods for men who have sex with men (MSM). Since 2016, in Canada, a man had to be abstinent from all sexual contact (anal or oral sex) with other men for at least 12 months in order to be an eligible blood donor. As of June 3, 2019, this deferral period was reduced to 3 months.&lt;/p&gt; &lt;p&gt;Methods&lt;/p&gt; &lt;p&gt;To better understand the acceptance of existing deferral policies and possible future policy, we conducted 47 in-depth interviews with a demographically diverse sample of gay, bisexual, queer, and other men who have sex with men (GBM) in Canada’s three largest cities: Vancouver, (&lt;em&gt;n&lt;/em&gt; = 17), Toronto (&lt;em&gt;n&lt;/em&gt; = 15), and Montreal (&lt;em&gt;n&lt;/em&gt; = 15). Interviews were coded in NVivo 11 following an inductive thematic analysis. We focus on men’s preferred policy directions and their opinions about a policy change proposed by Canada’s blood operators: &lt;em&gt;a 3-month deferral for all sexual activity between men.&lt;/em&gt; We interviewed GBM approximately one-year before this new deferral policy was approved by Health Canada.&lt;/p&gt; &lt;p&gt;Results&lt;/p&gt; &lt;p&gt;Most participants were opposed to any deferral period in relation to MSM-specific sexual activity. A fair and safe policy was one that was the “same for everyone” and included screening for several risk factors during the blood donation process with no categorical exclusion of all sexually active MSM. Participants believed that multiple “gender blind” and HIV testing-related strategies could be integrated into the blood donation process. These preferences for a move away from MSM-specific exclusions aligned with their opinions concerning the possible change to a 3-month MSM deferral, for which participants shared three overarching perspectives: (1) &lt;em&gt;step in the right direction&lt;/em&gt;; (2) &lt;em&gt;ambivalence and uncertainty&lt;/em&gt;; and (3) &lt;em&gt;not an improvement.&lt;/em&gt;&lt;/p&gt; &lt;p&gt;Conclusion&lt;/p&gt; &lt;p&gt;A predominant assertion was that a change from a 12-month to a 3-month deferral period would not resolve the fundamental issues of fairness and equity affecting blood screening practices for GBM in Canada. Many participants believed that blood donation policy should be based on more up-to-date scientific evidence concerning risk factor assessment and HIV testing.&lt;/p&gt;

Background: Blood products derived from donors on medication can contain drugs which might pose a risk for the recipients or influence the quality of the product itself. Material and Methods: To judge the eligibility of blood donors on medication, 4 drug classes have been formed with respect to their pharmacological properties, and blood products have been divided in accordance with their single-donor plasma contents. Results: For drugs with dose-dependent pharmacodynamics, no deferral periods are necessary for donation of blood products containing less than 50 ml single-donor plasma for application to adults. Waiting periods of tmax + 5 t_1/2 were calculated for the other blood products. Teratogenic drugs do not require special considerations (exception: retinoids, thalidomide and lenalidomide, dutasteride or finasteride with waiting periods for all blood products). A deferral period of t_max + 24 t_1/2 is proposed for every blood product from blood donors on genotoxic drugs. Drugs without systemic effects can be neglected. Irreversible inhibitors of platelet function cause a 10-day waiting period if production of platelet concentrates is intended. Conclusion: Donors on medication are allowed to donate blood for blood products containing less than 50 ml plasma of a single donor, like red blood cell concentrates, for the use in adults without deferral periods, except those taking retinoids, thalidomide, lenalidomide, dutasteride, finasteride, or genotoxic drugs.

The rules that govern blood donation vary globally. Some potential blood donors are ineligible for immediate blood donation, and as such are deferred until such time that they become eligible. This practice, the blood donation deferral period, is intended to reduce the risk of blood-borne infections being transfused into a blood product-recipient. As blood screening technologies improve, the risk of an infected blood product remaining undetected decreases-and so too have the deferral periods for certain donors. Much has been made of the importance of an evidence-based, scientific approach to protecting blood product-recipients. However, these deferrals are controversial. What exactly determines the blood donation deferral period? This article argues that blood donation deferral periods are not merely the result of enacting empirical data. Instead, the deferral periods represent a negotiation between scientific evidence, experts, politically expedient narratives, institutionalised risk aversion, as well as more mundane concerns such as operational feasibility. As a case study, I examine how the UK Advisory Committee on the Safety of Blood, Tissues and Organs changed the 12-month deferral period for blood donation from men who have sex with men to a 3-month deferral period.

Informed consent in transfusion medicine has been an area lacking of significant research and it is unknown if donors fully comprehend the risks associated with whole blood donation. To assess the adequacy of the informed consent process in whole blood donation. A brief questionnaire was constructed and distributed to whole blood donors visiting various fixed and mobile donor sites of the Central Pennsylvania Blood Bank. Questions consisted of demographic information; donor opinions of information content, length, and comprehension; and a short quiz pertaining to donor risks and eligibility. Analysis of 849 surveys demonstrated that donors comprehended a mean of 73.5% of the various donor eligibility and risks that were surveyed. Female and younger donors scored statistically higher on comprehension questions compared with male and older counterparts. Donors were most aware of (1) donor eligibility requirements related to acquired immunodeficiency syndrome comprehension, (2) the risk of dizziness postdonation, and (3) having lived in a certain country (93.7%-95.6% comprehension, respectively). Donors were least aware of (1) the risk of a possible referral to a physician for outstanding medical conditions or positive test results, (2) the risk of a positive test result, and (3) West Nile virus testing information (22.4%-49.3% comprehension, respectively). Whole blood donors believed that they were giving informed consent, but a significant percentage of donors were unaware of several of the risks associated with blood donation, including participation in West Nile virus research testing. Our data suggest that donors do not fully comprehend the risks of whole blood donation and that repetition of information to the donor, and in multiple formats, strengthens the level of comprehension and thus the informed consent process.

Background:Transfusion-transmissible malaria (TTM) is a major concern in malaria endemic countries. A study was therefore conducted to know sero-prevalence of malaria in blood donors and the risk of TTM to multi-transfused patients at our hospital.Materials and Methods:Study subjects were: eligible blood donors (n = 1000), donors deferred due to history of fever in the last 3 months (n = 100), and multi-transfused patients (n = 200). Screening for malaria was done by slide microscopy, immunochromatographic rapid diagnostic test (RDT) for malaria antigen, and anti-malaria antibody by enzyme linked immunosorbent assay.Results:Malaria antibody prevalence in eligible donors and donors with history of fever, thalassemia patients, and in other multi-transfused patients was 16.9%, 22%, 6%, and 15%, respectively. None of the donors were positive for malaria on microscopic examination. None of the blood donors except one donor with history of fever, tested positive with RDT.Conclusion:Malaria antibody prevalence in blood donors at our center is high. As blood units donated by such donors have high-risk potential, special processing may be undertaken to reduce the risk of TTM.

Context.—Informed consent in transfusion medicine has been an area lacking of significant research and it is unknown if donors fully comprehend the risks associated with whole blood donation. Objective.—To assess the adequacy of the informed consent process in whole blood donation. Design.—A brief questionnaire was constructed and distributed to whole blood donors visiting various fixed and mobile donor sites of the Central Pennsylvania Blood Bank. Questions consisted of demographic information; donor opinions of information content, length, and comprehension; and a short quiz pertaining to donor risks and eligibility. Results.—Analysis of 849 surveys demonstrated that donors comprehended a mean of 73.5% of the various donor eligibility and risks that were surveyed. Female and younger donors scored statistically higher on comprehension questions compared with male and older counterparts. Donors were most aware of (1) donor eligibility requirements related to acquired immunodeficiency syndrome com...

Background and Objectives: During the pandemic of CO­VID-19, additional blood donor eligibility criteria have been added to ensure safety of donors and donations. The aim of this study is to estimate the seroprevalence of SARS-CoV-2 antibody in eligible donors and to study the demography and lifestyle of asymptomatic cases. Materials and Methods: One thousand four hundred eighteen eligible donors were enrolled in this study in the Dubai Blood Donation Center from August to December 2020. Blood samples were tested for SARS-CoV-2 antibody. Donors’ demographic characteristics and lifestyle were studied further. The χ² test was used to analyze the data association. Results: 88.4% of the studied group were males, 85% were from age 17 to 45 years, and 53% were regular donors. The seroprevalence of SARS-CoV-2 antibody was 13.5% and significantly related to gender, frequency of donation, collection site, type of donation, and more frequent when donors shared transport and accommodation. Blood group and age had no significant association. 5.5% were found to have cough/fever or a history of contact with positive COVID-19 patients. Conclusions: The seroprevalence of SARS-CoV-2 antibody was 13.5% among eligible blood donors, and hence the current eligibility criteria allow asymptomatic COVID-19 patients to donate blood. The seroprevalence was seen more in first time donors, suggesting that regular blood donors are safer. Additional risk factors related to lifestyle can be identified to ensure safety of transfusion during COVID-19 pandemic.

Introduction: The ABO is a blood group system that is responsible for most blood transfusion reactions, transplant rejections and determining some forensic cases. The ABO and Rh blood group systems have been shown to show variations in different parts of the world and race. Haemoglobin is an intracellular protein found in red blood cells. Qualitative and quantitative abnormalities in this protein manifest as haemoglobinopathy.The study is to show the frequency and distribution of ABO, Rh blood groups and haemoglobin phenotype of eligible blood donors in Delta state University Teaching Hospital (DELSUTH), Nigeria Materials and Methods: This is a cross-sectional study of all blood donors attending the blood bank in DELSUTH from November 2022 to April 2003. Consecutive sampling technique was used and samples for blood group and haemoglobin genotype was collected from eligible donors. Data from the blood ban analysed using SPSS version 23. Results: A total of 95 donors were involved in the study. Analysis of the ABO blood group showed that the frequency blood group O,A,B and AB, were 83.2%,7.4%,7.4% and 2.2% respectively. RhD positive donors accounted for 93.7% of donors and RhD negative were 6.3%. 83.2% of donors had genotype AA while16.8% were genotype AS. Conclusion: Blood group O and RhD positive were the commonest blood group while genotype AA was the commonest genotype among blood donors in the facility.