Guidelines for the use of recombinant human erythropoietin.

ecombinant human erythropoietin (rHuEpo) is increasingly being used for the treatment of anemia. In view of the unpredictibility of response in most anemic states outside renal failure, the high economic cost, and the high expectation patients and physicians pose in its effect, its clinical use requires expertise and committment. This article was prepared by five experts: four on behalf of the Editorial Board of this Journal and one on behalf of the Dompé Biotec Company which sells rHuEpo in Italy. The Editorial Board of Haematologica and Dompe' Biotec agreed that minimal guidelines for the clinical use of rHuEpo would be useful for a safe, rational and cost-effective use of the drug, both for the approved indications of rHuEpo in Italy as well as the main anemic conditions potentially treatable with rHuEpo. This cooperation between a medical Journal and a pharmaceutical company is based on the common aim of achieving an optimal use of new drugs in medical practice. The method used for preparing these guidelines was an informal consensus development. The experts examined a list of problems concerning pre-treatment patient evaluation, dosing and monitoring therapy and cost-effectiveness evaluation. They discussed the single points in order to achieve an agreement on different judgments. This method for implementing guidelines is efficient in permitting the evaluation of a large number of clinical scenarios in a brief time, and the use of an expert panel improves the credibility of the recommendations produced. However, the panel is aware that this approach lacks both a formal meaning for the rating scale of the judgments and a formal mechanism for reconciling differences between panelists1. Settings of rHuEpo use rHuEpo is today employed in different settings. For certain indications, national scientific societies, local ad hoc committees, hospital departments staff have the role of leaders in the implementation of policy for the use of rHuEpo aimed at blood transfusions and their relative risks avoidance. According with this policy, Institutions implement planning and monitoring protocols for patient's management and audit the safety and the efficacy of treatment. We define this as Institutional setting. The treatment of anemia of patients with renal failure under dialysis, the management of anemia in surgical patients, the support of preoperative autologous blood donation, and the correction of anemia of prematurity are the major indications for this use. More frequently, however, the individual physician working in a hematologic or internal medicine specialty faces with the possible …