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Before optimal practice can be promoted, it must be defined
MJA 1997; 167: 462-463
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Most therapeutic agents are prescribed within a framework of
licensed indications agreed between the manufacturer and a
regulatory authority. However, single donor blood components are
not subject to this form of licensing, and rarely is rigorous evidence
of their efficacy available from large scale randomised studies, as
there is for other therapeutic agents, such as drugs. In an era when
medical practice is increasingly governed by the threat of
litigation, the proper use of blood products is particularly
sensitive and closely scrutinised. Prescription of blood products
based solely on presumed benefit, without balancing the risks of
infection and other complications, is no longer acceptable. Yet,
achieving the correct balance requires sound evidence of efficacy,
accurate risk assessment and effective methods of ensuring
universal good transfusion practice. How close are we to achieving
this?
Recent evidence suggests that a common understanding of the efficacy of blood components is a long way off. The Royal College of Physicians of Edinburgh consensus statement on red cell transfusion concluded: "...there is no general agreement at which point transfusion should be given, or on the optimal target concentration to be achieved. There is no single haemoglobin or haematocrit value applicable to all patients."1 For platelet transfusion, the "transfusion trigger" is more clearly defined. Even so, it was revised from 20x109/L to 15x109/L, or even 10x109/L in 1991.2 Further, a review of surgical transfusion practice in 43 hospitals in 10 countries of the European Union (the SANGUIS study) found that use of blood components in five common surgical procedures (hemicolectomy, coronary artery bypass grafts, abdominal aortic aneurysmectomy, transurethral resection of the prostate, total hip replacement) ranged from 0 to 80% of procedures for whole blood, 0 to 50% for fresh frozen plasma and 0 to 15% for platelets.3 Consequently, the cost in blood products varied by a factor of four for coronary artery bypass grafts, and a factor of 16 for transurethral resection of the prostate.
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| limiting use of blood components to occasions when they are strictly necessary would benefit patients, prescribers, suppliers and society |
If efficacy is difficult to define, are we better at assessing transfusion risk? Transfusion-transmitted infections are the focus of concern for prescribers and the public alike, and studies on this topic are welcome.4 However, national requirements for reporting and collating major transfusion hazards vary. The United States5 and France have mandatory reporting, and the United Kingdom recently launched voluntary reporting.6 Australia also has voluntary reporting systems in all States, but these are believed to be underutilised (Dr Gordon Whyte, Director, Victorian Red Cross Blood Bank, Melbourne, VIC, personal communication). However, although such data-gathering is critical for monitoring risk, there is no evidence as yet that it is effective in moderating transfusion prescribing. Even if best transfusion practice could be formulated, how could it be promoted? In this issue of the Journal, Tuckfield et al. assess one strategy -- prospective monitoring of blood product request forms.7 They found that, assessed on hospital guidelines, this approach markedly reduced the rate of inappropriate transfusions. This systematic review of blood product prescriptions may be more educational and have longer lasting effects than would a paper audit. However, it has the disadvantages of being labour intensive and possibly delaying treatment, and is probably not applicable on a regular basis.
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A range of other strategies have been used, including issuing of
national guidelines, consensus conferences and devolution of
budgets to prescribers. All have their drawbacks. For example,
guidelines produced at the national level have the potential to
reflect local practice as well as scientifically validated
assessments. The guidelines used by Tuckfield et al. could be
challenged on the same basis. The SANGUIS study suggests that basing
guidelines on current practice would lead to dramatically different
criteria in different European countries, against which, in case of
litigation, physicians might be judged.
In addition, results of strategies are not always as expected. After publication of national guidelines for use of fresh frozen plasma (FFP) in the UK,8 FFP issues from our blood centre actually increased, as subtherapeutic doses had often been used previously. In contrast, FFP use in Belgium decreased dramatically after a safer but more expensive product (virally inactivated FFP) was introduced without an overall budget increase. Ultimately, limiting use of blood components to occasions when they are strictly necessary would benefit patients, prescribers, suppliers and society. Patients would receive optimal treatment with the lowest risk of side effects and, in some countries, minimum out-of-pocket cost. Prescribers providing treatment according to guidelines would offer state-of-the-art care and be protected from legal action in the rare case of a nosocomial event. Suppliers would be able to supply products more easily because of decreased demand. In addition, by fulfilling their duty to ensure maximum precautions are taken to provide safe blood components according to, and sometimes beyond, national recommendations or regulations, and to inform providers of potential risks, suppliers would protect themselves from potential litigation. (For example, in the United Kingdom some blood centres introduced systematic screening for hepatitis C antibodies before it became mandatory.) At the end of this process, society would benefit, with optimal use of limited resources in the context of growing health expenditure. However, before rushing headlong into further expensive manoeuvres to improve transfusion practice, we should remember that the relative cost-effectiveness of guidelines, consensus conferences and other strategies, such as prospective monitoring, in changing transfusion practice has not been assessed. Failure to change practice is often blamed on the prescribers rather than on the limitations of the methods used. But who will audit the auditors? Jean-Pierre Allain
Lorna M Williamson
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