Epoetin in haemodialysis patients: impact of change from subcutaneous to intravenous routes of administration.
OBJECTIVE
Cases of erythroblastopenia, as an adverse effect to epoetin (EPREX), led to its use being restricted in Europe to the intravenous route (i.v.) since July 2002, in patients with chronic renal insufficiency. This work aimed at investigating the biological, pharmaceutical and economic impacts of this change in policy.


METHODS
We retrospectively compared the characteristics of 99 haemodialysis patients treated with epoetin at the time of the recommendation (July 2002) and 5 months after the policy change (November 2002).


RESULTS
In July 2002, 69 patients who were receiving EPREX subcutaneously (s.c./i.v. group) changed to the i.v. route of administration. Thirty other patients were already on i.v. epoetin (i.v. group). During the study period, the dose of epoetin increased significantly in the s.c./i.v. group but not in the i.v. group (46.83 +/- 10.20 UI/kg/week vs. 2.17 +/- 20.14 UI/kg/week respectively). This increased dosage was accounted for by a subgroup of 42 patients in the s.c./i.v. group while the others had dosage variations similar to those observed in the i.v. group. There were no significant clinical and biological changes associated with this change in route of administration. However, the change in policy led to the haemodialysis ward incurring an additional cost of 265,905 Euro (+32.7%) or an average annual extra cost of 1841 +/- 401 Euro per patient.


CONCLUSIONS
Changing the route of administration of EPREX from the i.v. to the subcutaneous route required an increase in dosage and in substantial additional cost.
CH Valenciennes, Avenue Desandrouins, Valenciennes, France.
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D000368:Aged; D003362:Cost-Benefit Analysis; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D005602:France; D006397:Hematinics / Q000008:administration & dosage*; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D011358:Product Surveillance, Postmarketing; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000191:economics*; D012189:Retrospective Studies
D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa