Clinical appropriateness of blood component transfusion: regulatory requirements and standards set by the Scientific Society in Italy.

Abstract

Decision-making in health care is strongly conditioned by values of patients and providers, available resources, and information showing effectiveness/efficacy of a particular health care intervention. Clinical decisions concerning treating patients should, as far as possible, be evidence-based1; this is, to a great extent, current clinical dogma, and many medical practitioners in all disciplines are now, to some extent, utilising it2. Evidence-based medicine (EBM) can be defined as conscientious, explicit and judicious use of current best evidence in making decisions about care of individual patients3. It combines clinical judgment and experience with best available scientific evidence to improve medical decision-making and should provide clinicians, health care systems and policy-makers with instruments to appropriately evaluate scientific evidence supporting various diagnostic and therapeutic activities. This represents a radical departure from usual and customary methods for making treatment decisions concerning patients and has led to EBM being a discipline taught in medical schools and teaching hospitals4. Transfusion medicine (TM) is currently adopting principles and research methodologies that support EBM5, and high-level research has actually been undertaken at same rate as in all medical specialties combined in terms of numbers of randomised controlled trials and meta-analyses1. EBM in TM not only refers to best research evidence, but is often based on a broader range of inputs, including public expectations about transfusion safety and issues concerning precautionary principle; this implies that criteria for evaluating efficacy and cost-effectiveness of interventions in TM may differ substantially from those used in other areas6. The increasing need to deliver sufficient and safe blood components of high quality may be cause of an excessive focus on supply side of blood transfusion chain rather than clinical problem facing patients and clinicians7. An overwhelming concentration on blood supply can lead to appropriate clinical utilisation of blood components being ignored as a potentially useful instrument to maintain blood supply itself, although physicians should always consider clinical appropriateness as a must, under professional, scientific and ethical points of view. Hence, the appropriateness of transfusion practices will only improve, not by expecting clinicians to be gatekeepers of blood supply, but with better patient blood management based on a sound understanding of pathophysiology and better evidence for transfusion efficacy7. Based on above considerations, appropriateness of transfusion practices should systematically mean that blood components are transfused only when there is evidence for potential benefit, there are no valid alternatives, safe and quality products are available, and risks and benefits are carefully assessed before decision to transfuse is made. Recent European regulatory acts in field of blood transfusion (Directive of Council 2002/98/EC8 and Directives of Commission 2005/61/EC9 and 2005/62/EC10), while focusing on fundamental issues concerning quality, safety, traceability, haemovigilance, etc., do not actually take into consideration promotion and assessment of appropriateness of clinical use of blood components11. Indeed, Community's legislative framework excludes actual therapeutic use of blood components. Moreover, its provisions are no longer applicable when components are sent for further processing into medicinal products, when pharmaceutical legislation comes into force12. The appropriateness of clinical use of blood components is addressed by Recommendation Rec(2002)1113, which is indeed an excellent guideline to member states on how and what to do to implement optimal use of blood and blood products in clinical setting, but no mandatory act at European level establishes that appropriateness of transfusion practices must be promoted, monitored, assessed and, when necessary, improved. This review is aimed at providing an overview of Italian regulatory framework and of requirements of Italian standards of TM on assessment of appropriateness of blood transfusion.