Publications by authors named "Albert Farrugia"

73 Publications

Clinical Trial Design for Alpha-1 Antitrypsin Deficiency: A Model for Rare Diseases.

Chronic Obstr Pulm Dis 2015 Apr 28;2(2):177-190. Epub 2015 Apr 28.

Division of Pulmonary and Critical Care Medicine, University of Miami and Alpha-1 Foundation, Miami, Florida.

Clinical research in rare diseases, including alpha-1 antitrypsin deficiency (AATD), faces challenges not shared by common disease research. These challenges may include the limited number of patient volunteers available for research, lack of natural history studies on which to base many clinical trial interventions, an urgency for the development of drug therapies given the often poor prognosis of rare diseases and uncertainties about appropriate biomarkers and clinical outcomes critical to clinical trial design. To address these challenges and initiate formal discussions among key stakeholders-patients, researchers, industry, federal regulators-the Alpha-1 Foundation hosted the conference February 3-4, 2014 in Bethesda, Maryland. Discussions at the conference led to the conclusions that 1) adaptive designs should be considered for rare disease clinical trials yet more dialogue and study is needed to make these designs feasible for smaller trials and to address current limitations; 2) natural history studies, including the identification of appropriate biomarkers are critically needed and precompetitive collaborations may offer a means of creating these costly studies; and 3) patient registries and databases within the rare disease community need to be more publicly available and integrated, particularly for AATD. This report summarizes the discussions leading to these conclusions.
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http://dx.doi.org/10.15326/jcopdf.2.2.2015.0132DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5556970PMC
April 2015

Errors and Omissions: Donor Compensation Policies and Richard Titmuss.

HEC Forum 2015 Dec;27(4):319-30

Plasma Protein Therapeutics Association, Annapolis, MD, USA.

Many global and national systems of regulation of blood donors and donor compensation rely for intellectual support on Richard Titmuss's views, represented in The Gift Relationship. Based on selective interpretation of data from the 1960s, Titmuss engineered an ethical view pertaining to donors and, in so doing, created not only ongoing stereotypes, but created a cause for followers to perpetuate misunderstandings about the nature of such donations. In many cases, donors are, in fact compensated, but regulatory systems persevere in using definitional fig leaves in order to perpetuate an ongoing political goal of diminishing private sector participation in health care. However, in more recent works, including new views of critical sociology and evolutionary psychology, the Titmuss worldview has been turned upside-down. Evidence readily available today proves the safety of compensated donation and the lives saved by encouraging policies for both compensated and non-compensated donation.
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http://dx.doi.org/10.1007/s10730-015-9267-7DOI Listing
December 2015

Reflections on the emergence of chikungunya virus in the United States: time to revisit a successful paradigm for the safety of blood-derived therapies.

Transfusion 2015 Jan;55(1):224-6

Department of Surgery, University of Western Australia, Crawley, WA, Australia.

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http://dx.doi.org/10.1111/trf.12933DOI Listing
January 2015

Manufacture of immunoglobulin products for patients with primary antibody deficiencies - the effect of processing conditions on product safety and efficacy.

Front Immunol 2014 23;5:665. Epub 2014 Dec 23.

Department of Molecular Medicine, Sapienza University of Rome , Rome , Italy.

Early preparations of immunoglobulin (Ig) manufactured from human plasma by ethanol (Cohn) fractionation were limited in their usefulness for substitution therapy in patients with primary antibody deficiencies (PAD), as Ig aggregates formed during manufacture resulted in severe systemic reactions in patients when given intravenously. Developments in manufacturing technology obviated this problem through the capacity to produce concentrated solutions of intact monomeric Ig, revolutionizing PAD treatment and improving patient life expectancy and quality of life. As the need for Ig has grown, manufacturers have refined further manufacturing technologies to improve yield from plasma and produce therapies, which are easier and less expensive to deliver. This has led to the substitution, partly or wholly, of ethanol precipitation by other techniques such as chromatography, and has also stimulated the production of highly concentrated solutions capable of rapid infusion. Ig products have been associated, since their inception, with certain adverse events, including infectious disease transmission, hemolysis, and thromboembolism. The introduction of standardized manufacturing processes and dedicated pathogen elimination steps has removed the risk of infectious disease, and the focus of attention has shifted to other problems, which appear to have increased over the past 5 years. These include hemolysis and thromboembolism, both the cause for substantial concern and the subject of recent regulatory scrutiny and actions. We review the development of manufacturing technology and the emerging evidence that changes for the optimization of yield and convenience has contributed to the recent incidents in certain adverse events. Industry measures under development will be discussed in terms of their potential to improve safety and optimize care for patients with PAD.
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http://dx.doi.org/10.3389/fimmu.2014.00665DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4274962PMC
January 2015

Hemolysis in patients with antibody deficiencies on immunoglobulin replacement treatment.

Transfusion 2015 May 22;55(5):1067-74. Epub 2014 Dec 22.

Unit of Immunohematology and Transfusion Medicine, Sapienza University of Rome, Rome, Italy.

Background: Immunoglobulin (Ig)G replacement with intravenous or subcutaneous immunoglobulins is a lifelong substitutive therapy in patients with primary antibody deficiencies (PADs). Hemolysis after immunoglobulin therapy was described in patients receiving high immunoglobulin dosages. The issue of hemolysis after immunoglobulin administration at replacement doses has been considered of little clinical significance.

Study Design And Methods: This was a single-center observational study over a 2-year period on immunoglobulin-induced hemolysis in a cohort of 162 patients with PADs treated with immunoglobulin administered at replacement dosages.

Results: Six patients had signs and symptoms of immunoglobulin-induced hemolysis. Two additional asymptomatic patients were identified by a short-term study run on 16 randomly selected asymptomatic patients. Alloantibodies eluted from patients' red blood cells (RBCs) had anti-A and Rh specificities (anti-D and anti-C). The immunoglobulins contained alloantibodies with the same specificities of the antibodies eluted from patients' RBCs.

Conclusion: Hemolysis occurred in patients receiving immunoglobulin at replacement dosages. Polyvalent immunoglobulin preparations contained multiple clinically significant antibodies that could have unexpected hemolytic consequences, as anti-C whose research and titration are not required by the European Pharmacopoeia. The issue of hemolysis in long-term recipients of immunoglobulin treatment administered at replacement dosages should be more widely recognized.
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http://dx.doi.org/10.1111/trf.12939DOI Listing
May 2015

The Ethics of Paid Plasma Donation: A Plea for Patient Centeredness.

HEC Forum 2015 Dec;27(4):417-29

Plasma Protein Therapeutics Association, Annapolis, MD, USA.

Plasma protein therapies (PPTs) are a group of essential medicines extracted from human plasma through processes of industrial scale fractionation. They are used primarily to treat a number of rare, chronic disorders ensuing from inherited or acquired deficiencies of a number of physiologically essential proteins. These disorders include hemophilia A and B, different immunodeficiencies and alpha 1-antitrypsin deficiency. In addition, acute blood loss, burns and sepsis are treated by PPTs. Hence, a population of vulnerable and very sick individuals is dependent on these products. In addition, the continued well-being of large sections of the community, including pregnant women and their children, travelers and workers exposed to infectious risk is also subject to the availability of these therapies. Their manufacture to adequate amounts requires large volumes of human plasma as the starting material of a complex purification process. Mainstream blood transfusion services run primarily by the not-for-profit sector have attempted to provide this plasma through the separation of blood donations, but have failed to provide sufficient amounts to meet the clinical demand. The collection of plasma from donors willing to commit to the process of plasmapheresis, which is not only time consuming but requires a long term, continuing commitment, generates much higher amounts of plasma and has been an activity historically separate from the blood transfusion sector and run by commercial companies. These companies now supply two-thirds of the growing global need for these therapies, while the mainstream government-run blood sector continues to supply a shrinking proportion. The private sector plasmapheresis activity which provides the bulk of treatment products has been compensating the donors in order to recognize the time and effort required. Recent activities have reignited the debate regarding the ethical and medical aspects of such compensation. In this work, we review the landscape; assess the contributions made by the compensated and non-compensated sectors and synthesize the outcomes on the relevant patient communities of perturbing the current paradigm of compensated plasma donation. We conclude that the current era of "Patient Centeredness" in health care demands the continuation and extension of paid plasma donation.
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http://dx.doi.org/10.1007/s10730-014-9253-5DOI Listing
December 2015

Hemophilia treatment and the AIDS tragedy: closing the circle.

Authors:
Albert Farrugia

Transfusion 2014 Apr;54(4):1199

Department of Surgery, University of Western Australia, Crawley, WA, Australia; Global Access, Plasma Protein Therapeutics Association, Annapolis, MD.

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http://dx.doi.org/10.1111/trf.12527DOI Listing
April 2014

Toward a patient-based paradigm for blood transfusion.

J Blood Med 2014 31;5:5-13. Epub 2014 Jan 31.

Cedars-Sinai Medical Center, Los Angeles, CA, USA.

The current "manufacturing paradigm" of transfusion practice has detached transfusion from the clinical environment. As an example, fresh whole blood in large-volume hemorrhage may be superior to whole blood reconstituted from multiple components. Multicomponent apheresis can overcome logistical difficulties in matching patient needs with fresh component availability and can deliver the benefits of fresh whole blood. Because of the different transfusion needs of patients in emerging economies and the vulnerability of these blood systems to emerging infections, fresh whole blood and multicomponent apheresis can better meet patient needs when compared with transplants of the "manufacturing paradigm". We propose that patient blood management, along with panels of repeat, paid, accredited apheresis and fresh whole-blood donors can be used in emerging economies to support decentralized blood services. This alternative transfusion-medicine paradigm could eventually also be adopted by established economies to focus transfusion medicine on local patient needs and to alleviate the problem of the aging volunteer donor base.
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http://dx.doi.org/10.2147/JBM.S55769DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3917954PMC
February 2014

Modeling primary immunodeficiency disease epidemiology and its treatment to estimate latent therapeutic demand for immunoglobulin.

J Clin Immunol 2014 Feb 12;34(2):233-44. Epub 2013 Dec 12.

Department of Business Management, Poole College of Management, North Carolina State University, Raleigh, NC, 27695, USA,

Purpose: Estimating the underlying demand for immunoglobulin (Ig) is important to ensure that adequate provision is made for patients with primary immune deficiency (PID) in the context of the competing demands for Ig and to ensure optimal therapeutic regimens. The concept of latent therapeutic demand (LTD) was used to estimate evidence-based requirements and compared to the actual Ig consumption in different countries. The estimates were performed for common variable immunodeficiency (CVID) and X-linked Agammaglobulinaemia (XLA), the two most commonly studied PIDs using Ig.

Methods: The LTD model for CVID and XLA was derived using decision analysis methodology. Data for the epidemiology and treatment variables were obtained from peer-reviewed publications, clinical registries and publicly-available patient surveys. Incomplete data records from registries were excluded from analysis. The variables impacting LTD were ranked in order of sensitivity through a tornado diagram. The uncertainty surrounding the variables was modeled using probabilistic distributions and evaluated using Monte Carlo simulation.

Results: Treatment dosage and prevalence were determined to be the most sensitive variables driving demand. The average potential usage of Ig for the treatment of CVID and XLA was estimated at 72 g per 1,000 population, which is higher than the estimated Ig usage in CVID and XLA of 27-41 g per 1,000 population in the US.

Conclusion: The potential demand for treating CVID and XLA exceeds the currently observed usage of Ig in these disorders. Variable usage in different countries is due to varying prevalence and dosage practices. Under-reporting in patient registries represents a major obstacle to calculating the true prevalence of CVID and XLA. Modeling demand relies heavily upon accurate prevalence and practice estimates which reemphasize the importance of accurate registries and improved registry methods. As better data becomes available, revision of model variables provides opportunities to anticipate and prepare for evolving patient needs.
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http://dx.doi.org/10.1007/s10875-013-9975-1DOI Listing
February 2014

Choice of Fluids in Severe Septic Patients - A Cost-effectiveness Analysis Informed by Recent Clinical Trials.

Rev Recent Clin Trials 2014 ;9(1):21-30

147 Old Solomons Island Road, Suite#100, Annapolis, MD 21401, Australia.

Fluid resuscitation with colloids is an established second line therapy for septic patients. Evidence of relative efficacy outcomes is tempered by considerations of the relative costs of the individual fluids. An assessment of recent large clinical trials was performed, resulting in a ranking in the efficacy of these therapies. Probabilities for mortality and the need for renal replacement therapy (RRT) were derived and used to inform a decision analysis model comparing the effect of crystalloid, albumin and hydroxyethyl starch solutions in severe septic patients followed from hospital admission to 90 days in intensive care. The US payer perspective was used. Model inputs for costs and efficacy were derived from the peer-reviewed literature, assuming that that all fluid preparations are bio-equivalent within each class of these therapies. Probabilities for mortality and the need for renal replacement therapy (RRT) data were synthesized using a Bayesian meta-analysis. Relative to crystalloid therapy, 0.21 life years were gained with albumin and 0.85 life years were lost with hydroxyethyl starch. One-way sensitivity analysis showed that the model's outcomes were sensitive to the cost of RRT but not to the costs of the actual fluids or any other costs. We conclude that albumin may be the most cost-effective treatment in these patients when the total medical costs and iatrogenic morbidities involved in treating sepsis with fluids are considered. These results should assist and inform decision making in the choice of these drugs.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4112378PMC
http://dx.doi.org/10.2174/1574887108666131213120816DOI Listing
March 2016

Economic considerations on transfusion medicine and patient blood management.

Best Pract Res Clin Anaesthesiol 2013 Mar;27(1):59-68

Institute of Anaesthesiology, University Hospital and University of Zurich, Zurich, Switzerland.

In times of escalating health-care cost, it is of great importance to carefully assess the cost-effectiveness and appropriateness of the most resource-consuming health interventions. A long-standing and common clinical practice that has been underestimated in cost and overestimated in effectiveness is the transfusion of allogeneic blood products. Studies show that this intervention comes with largely underestimated service cost and unacceptably high utilisation variability for matched patients, thus adding billions of unnecessary dollars to the health-care expenditure each year. Moreover, a large and increasing body of literature points to a dose-dependent increase of morbidity and mortality and adverse long-term outcomes associated with transfusion whereas published evidence for benefit is extremely limited. This means that transfusion may be a generator for increased hospital stay and possible re-admissions, resulting in additional billions in unnecessary expenditure for the health system. In contrast to this, there are evidence-based and cost-effective treatment options available to pre-empt and reduce allogeneic transfusions. The patient-specific rather than a product-centred application of these multiple modalities is termed patient blood management (PBM). From a health-economic perspective, the expeditious implementation of PBM programmes is clearly indicated. Both patients and payers could benefit from this concept that has recently been endorsed through the World Health Assembly resolution WHA63.12.
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http://dx.doi.org/10.1016/j.bpa.2013.02.001DOI Listing
March 2013

Is self-sufficiency in haemotherapies a practical or necessary goal?

Blood Transfus 2013 Apr 13;11(2):183-92. Epub 2012 Dec 13.

School of Medicine, Australian National University, Canberra, Australia.

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http://dx.doi.org/10.2450/2012.0148-12DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3626469PMC
April 2013

External financial aid to blood transfusion services in sub-Saharan Africa: a need for reflection.

PLoS Med 2012 11;9(9):e1001309. Epub 2012 Sep 11.

University of Cambridge, Cambridge, United Kingdom.

Jean-Pierre Allain and colleagues argue that, while unintended, the foreign aid provided for blood transfusion services in sub-Saharan Africa has resulted in serious negative outcomes, which requires reflection and rethinking.
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http://dx.doi.org/10.1371/journal.pmed.1001309DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3439367PMC
February 2013

Albumin from rice: why and wherefore?

Proc Natl Acad Sci U S A 2012 Apr 16;109(14):E775. Epub 2012 Mar 16.

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http://dx.doi.org/10.1073/pnas.1119395109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3325709PMC
April 2012

Plasma-derived medicines: access and usage issues.

Blood Transfus 2012 Jul 21;10(3):273-8. Epub 2012 Dec 21.

School of Surgery, University of Western Australia, Crawley, Western Australia, Australia.

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http://dx.doi.org/10.2450/2011.0118-11DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3417725PMC
July 2012

Conditions for plasma processing.

Transfusion 2011 Aug;51(8):1875-6; author reply 1876

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http://dx.doi.org/10.1111/j.1537-2995.2011.03214.xDOI Listing
August 2011

HIV safety in sub-Saharan Africa.

Vox Sang 2011 May 26;100(4):434-5; author reply 436-7. Epub 2010 Oct 26.

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http://dx.doi.org/10.1111/j.1423-0410.2010.01430.xDOI Listing
May 2011

Falsification or paradigm shift? Toward a revision of the common sense of transfusion.

Authors:
Albert Farrugia

Transfusion 2011 Jan 17;51(1):216-24. Epub 2010 Aug 17.

Centre for Orthopaedic Research, Department of Surgery, Faculty of Medicine and Surgery, University of Western Australia, WA, Australia.

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http://dx.doi.org/10.1111/j.1537-2995.2010.02817.xDOI Listing
January 2011

Response to Volkow P et al. - Cross-border paid plasma donation among injection drug users in two Mexico-U.S. border cities - International Journal of Drug Policy 20 (2009) 409-412.

Int J Drug Policy 2010 Sep 23;21(5):343-4; discussion 345-6. Epub 2010 May 23.

Plasma Protein Therapeutics Association, Global Access, Suite 100, 147 Old Solomon's Island Road, Annapolis, MD 21401, USA.

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http://dx.doi.org/10.1016/j.drugpo.2010.04.005DOI Listing
September 2010

Safety of plasma volume expanders.

Authors:
Albert Farrugia

J Clin Pharmacol 2011 Mar 25;51(3):292-300. Epub 2010 May 25.

Plasma Protein Therapeutics Association, 147 Old Solomon's Island Road, Annapolis, MD 21401, USA.

Hypovolemia from a range of etiologies can lead to severe morbidity and mortality unless blood volume and tissue perfusion are restored. The treatment of hypovolemia has included the improvement and restoration of blood volume loss by the intravenous infusion of plasma expanding therapeutic agents. These have included crystalloid and/or colloid solutions, and a brisk controversy as to which modality is better has engaged therapeutics for the past 30 years. In addition, those favoring either modality have debated which crystalloid, and which colloid, is better. This area was given a dramatic turn a decade ago when a Cochrane meta-analysis concluded that albumin, a historically important plasma expander, resulted in increased mortality when administered to critically ill patients. Although subsequently modified by other studies, the Cochrane meta-analysis has served to generate an ongoing interest in the safety of plasma expanders. This review will assess the safety of these therapies from the viewpoint of the heterogeneous range of clinical indications for which they are used.
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http://dx.doi.org/10.1177/0091270010372107DOI Listing
March 2011

Albumin usage in clinical medicine: tradition or therapeutic?

Authors:
Albert Farrugia

Transfus Med Rev 2010 Jan;24(1):53-63

Plasma Protein Therapeutics Association, Annapolis, MD 21401, USA.

Plasma protein therapies have been sheltered historically from the scrutiny of evidence-based medicine. Thus, a number of albumin solutions became part of the established therapeutic armamentarium with a very modest evidence base. As evidence-based medicine has turned its focus on plasma protein therapies, albumin's appropriate use has become increasingly questioned. Concurrently, interest in other colloid plasma expanders has increased as efforts to address their side-effects have resulted in new products. The decade-old meta-analysis from the Cochrane collaboration linking albumin with increased mortality, although currently disproven, has resulted in ongoing scrutiny of albumin's safety and has led to a large randomized clinical trial which, while demonstrating equivalent safety with saline, has also shown equivalent mortality in the patient population assessed. Albumin's manufacture yields products which vary between different brands, as well as occasionally between batches from the same brand. These changes affect albumin's physiologic properties and may contribute to the different therapeutic effects observed in clinical practice. More clinical investigations of albumin's therapeutic role are needed before its unique biological features can be shown to result in therapeutically useful drugs.
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http://dx.doi.org/10.1016/j.tmrv.2009.09.005DOI Listing
January 2010

Plasma fractionation issues.

Biologicals 2009 Apr 16;37(2):88-93. Epub 2009 Mar 16.

Blood and Tissues Unit, Office of Devices, Blood and Tissues, Therapeutic Goods Administration, Woden, ACT 2606, Australia.

Procurement and processing of human plasma for fractionation of therapeutic proteins or biological medicines used in clinical practice is a multi-billion dollar international trade. Together the private sector and public sector (non-profit) provide large amounts of safe and effective therapeutic plasma proteins needed worldwide. The principal therapeutic proteins produced by the dichotomous industry include gamma globulins or immunoglobulins (including pathogen-specific hyperimmune globulins, such as hepatitis B immune globulins) albumin, factor VIII and Factor IX concentrates. Viral inactivation, principally by solvent detergent and other processes, has proven highly effective in preventing transmission of enveloped viruses, viz. HBV, HIV, and HCV.
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http://dx.doi.org/10.1016/j.biologicals.2009.01.005DOI Listing
April 2009

Stem cell and cellular therapy developments.

Biologicals 2009 Apr 20;37(2):103-7. Epub 2009 Feb 20.

Northwest Tissue Center, Puget Sound Blood Center, USA.

Recent discoveries on human and non-human stem cells have prompted the development of several studies aimed at the translation of laboratory evidences into novel clinical procedures collectively known as 'cellular therapy'. In this regard, a number of features specifically related to the clinical setting require stringent evaluation, including, but not limited to: ethical appropriateness; donor and recipient informed consent; autologous versus allogeneic use; media and devices for cell collection, processing, characterization, storage and distribution; donor and recipient adverse events registration and management; risk-to-benefit and cost analysis; outcome analysis; production sites accreditation and management; regulatory oversight. This article describes recent national and international developments related to the distribution of cells and tissues for clinical use. Moreover, an example is reported of the implementation of a cellular therapy production site compliant with good manufacturing practices (GMPs) in a large European University hospital.
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http://dx.doi.org/10.1016/j.biologicals.2009.01.003DOI Listing
April 2009

Globalisation and blood safety.

Authors:
Albert Farrugia

Blood Rev 2009 May 9;23(3):123-8. Epub 2008 Dec 9.

Blood and Tissues Unit, Australian Therapeutic Goods Administration, ACT, Australia.

Globalisation may be viewed as the growing interdependence of countries worldwide through the increasing volume and variety of cross-border transactions in goods and services, and also through the more rapid and widespread diffusion of technology. Globalisation is not just an economic phenomenon, although it is frequently described as such, but includes commerce, disease and travel, and immigration, and as such it affects blood safety and supply in various ways. The relatively short travel times offered by modern aviation can result in the rapid spread of blood-borne pathogens before measures to counteract transmission can be put in place; this would have happened with SARS if the basic life cycle of the SARS virus included an asymptomatic viraemia. This risk can be amplified by ecological factors which effect the spread of these pathogens once they are transferred to a naïve ecosystem, as happened with West Nile Virus (WNV) in North America. The rationalization and contraction of the plasma products industry may be viewed as one aspect of globalisation imposed by the remorseless inevitability of the market; the effect of this development on the safety and supply of products has yet to be seen, but the oversight and assurance of a shrinking number of players will present particular challenges. Similarly, the monopolization of technology, through patent enforcement which puts access beyond the reach of developing countries, can have an effect on blood safety. The challenges presented to blood safety by globalisation are heightening the tensions between the traditional focus on the product safety - zero risk paradigm and the need to view the delivery of safe blood as an integrated process. As an illustration of this tension, donor deferral measures imposed by globalisation-induced risks such as vCJD and WNV have resulted in the loss of the safest and most committed portion of the blood donor population in many Western countries, leading to an increased risk to safety and supply. It is only through an appreciation of the basic needs of transfusion medicine, including the enunciation of appropriate principles to manage, rather than eliminate, risks, that the challenges imposed by globalisation may be overcome.
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http://dx.doi.org/10.1016/j.blre.2008.10.004DOI Listing
May 2009

Comparison of the risk of viral infection between the living and nonliving musculoskeletal tissue donors in Australia.

Transpl Int 2008 Oct 5;21(10):936-41. Epub 2008 Jun 5.

Centre for Orthopaedic Research, School of Surgery and Pathology, University of Western Australia, Perth, WA, Australia.

Screening of musculoskeletal tissue donors with nucleic acid testing (NAT) for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) has been implemented in the United States and other developed nations. However, in contrast to the donor demographics in the United States, the majority of Australian musculoskeletal tissue donations are primarily from living surgical donors. The objective of our study was to determine and compare the risk of viral infection associated with musculoskeletal tissue donation from living and nonliving donors in Australia. We studied serum samples from 12 415 consecutive musculoskeletal tissue donors between 1993 and 2004. This included 10 937 surgical donations, and 1478 donations obtained from postmortem organ donation patients and cadaveric donors. Current mandatory retesting of surgical donors 6 months postdonation reduces the risk of viral infection by approximately 95% by eliminating almost all donors in the window period. The addition of nucleic acid amplification testing for nonliving donors would similarly reduce the window period, and consequently the residual risk by approximately 50% for hepatitis B virus, 55% for HIV, and 90% for HCV. NAT, using appropriately validated assays for nonliving donors, would reduce the residual risk to levels comparable to that in living donors (where the 95% reduction for quarantining pending the 180-day re-test is included).
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http://dx.doi.org/10.1111/j.1432-2277.2008.00703.xDOI Listing
October 2008
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