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Published on 2 March 2009

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Simplified single-sheet erythropoietin protocol for anaemia management in chronic kidney disease dialysis patients

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A simple protocol was developed and supervised by the authors for anaemia management of adult dialysis patients. A study into its use found it was well received by the dialysis nurses, who found it easy to implement in their busy working schedule

Clarissa Captur
BPharm(Hons)
MScClinPharm(Aberdeen)
MRPharmS(Lond) PGCert
Renal(Brighton)
Clinical Pharmacist

Emanuel Farrugia
MD FRC P(Lond & Edin)
DipNeph(Lond) FAC P FEFIM
Head of Nephrology
Department of Medicine
Mater Dei Hospital
Msida
Malta

Administration of an erythropoiesis-stimulating agent (ESA ) is the mainstay of treatment of anaemia in patients with chronic kidney disease (CKD) on dialysis. For patients with CKD, the European Best Practice Guidelines recommend a target haemoglobin (Hgb) of 11 g/dl, and the National Kidney Foundation Dialysis Outcome Quality Initiative (KDO QI) recommends a target Hgb of 11-12 g/dl, but not greater than 13 g/dl.[1] To consistently maintain patients Hgb within a narrow range requires frequent monitoring of their Hgb and iron studies and periodic adjustment of ESA doses and administration of intravenous iron. To achieve and maintain an optimal target Hgb in these patients, anaemia management protocols have largely replaced physicians ad-hoc management, as they provide standardised guidance to dialysis nurses for dosing interventions.[2-4] Protocols are bound to differ across renal units, even within a region and, more so, between different countries, as they have to take into account variables such as economic factors, the pharmaceutical preparation(s) of ESA available, the route of administration, dialysis patient population mix, concurrent iron management protocols and physician bias, especially with regards to target haemoglobins.

[[HPE41.59]]

ESA protocols vary in their degree of complexity, and some may prove cumbersome to use, especially in busy renal units that lack a dedicated anaemia management pharmacist/nurse. The purpose of this study was to have a clinical pharmacist formulate and implement a single-sheet, simple-to-use ESA protocol or algorithm (Figure 1) in adult dialysis patients. Additionally, the protocol had to be relevant for both haemodialysis (HD) and continuous ambulatory peritoneal dialysis (CAPD) patients. The protocol exclusively utilised epoetin beta (EPO) in a prefilled formulation, as this was the only ESA
available at the renal unit at the time. The subcutaneous (SC) route was chosen to maximise the cost savings benefit from the higher bioavailability resulting with SC as compared to intravenous (IV) administration.

Practical considerations in the development of the protocol
Dosing schedules based on body weight were deemed to be  cumbersome. The protocol was designed so that the EPO dose would always be initiated at 2,000 to 4,000 units/session. Subsequent dose steps were likewise not based on body weight, but in multiples of 1,000 units. When a change in EPO dose was indicated, only a one-step change had to be made. A second
consideration was that for HD patients, EPO dose steps had to specified per dialysis session, whereas in CAPD patients, a per-week calculation was allowed. This was done to facilitate dosing in that group of HD patients who did not have the standard three-week dialysis schedule, and who received more (eg, alternate day), or less (eg, twice-a-week) dialysis runs. In
CAPD patients, the initial EPO dose was similar to HD patients, but as already mentioned, the dose changes were calculated on a weekly basis. The amount could then be administered once, twice or three times a week, as long as the total weekly EPO dose was as per protocol. An important point for us was that
the protocol had to ensure that EPO dosage instructions addressed all the possible different Hgb levels, all possible prior EPO dosage regimen scenarios and all phases of treatment (initial, maintenance and discontinuation phases).

Validation
To validate this protocol, and to assess its impact on patients, demographic data and data of the outcome measures, before and after the implementation of the protocol (Table 1) was collected in a sample of patients (84 out of a total dialysis population of 200). The chosen valid, reliable and sensitive outcome measures of the study included: Hgb level, total number of units of EPO used, total number of units of blood transfused, dose of IV/po iron used, serum ferritin concentration
level, number of hospital admissions, number of adverse events due to EPO, number of EPO dose changes and cost of EPO. During the study, patients also received IV iron as per a previously established iron protocol that delivered iron when the serum ferritin level <500 ng/ml.

Results of validation study
There was a statistically significant difference between the total mean Hgb levels recorded during the retrospective and prospective analysis phase of the study in the HD patient group (11.4 g/dl and 12.2 g/dl, respectively; p=0.0002), but not in the CAPD group (12.6 g/dl and 12.3 g/dl, respectively; p=0.34). The proportion of HD patients achieving a Hgb level within the
target range was higher during the prospective period than  during the retrospective part of the study (61% vs 56%, respectively), unlike in the CAPD patients (41% vs 66%, respectively). For both the HD and CAPD patients the total cost of EPO was increased in the prospective period vs the retrospective period (29,405euro vs 18,330euro and 9,329euro vs 7,183euro, respectively).

[[HPE41.592]]

Conclusion
The protocol developed and supervised by the authors for anaemia management of adult HD and CAPD patients was well received by the dialysis nurses, who liked its simple format and found it easy to implement in their busy working schedule. The protocol led to a positive impact, especially within the HD patient pool, and an inevitable increase in costs associated with improved efforts at attaining the latest recommended target Hgb range of 11.0—13.0 g/dl. In CAPD patients, the algorithm failed to increase the mean Hgb level, although the numbers were too small to draw a definite conclusion. One explanation for this observation could be that the CAPD patients had a significantly higher baseline mean Hgb level (better preserved renal function, avoidance of blood loss during dialysis). Possibly
also, CAPD patients who all self-inject the EPO at home in an unsupervised environment may have not complied with their prescribed higher doses of EPO. Notwithstanding, we feel that this simple-to-use protocol for epoetin beta has fulfilled our renal unit expectations by standardising management and improving
Hgb levels, at least for now in our HD population.

References
1. National Collaborating Centre for Chronic Conditions. Anaemia management in chronic kidney disease: national clinical guideline for management in adults and children. London: Royal College of Physicians. 2006.
2. Brimble KS, et al. Protocolized anemia management with
erythropoietin in hemodialysis patients: a randomised controlled trial. JASN 2003;14(10):2654-61.
3. Nhan J, et al. Evaluation of an anemia algorithm in chronic
hemodialysis patients. CANNT J 2007;17(3):48-58, 62-73.
4. Patterson P, et al. Prospective evaluation of an anemia treatment algorithm in haemodialysis patients. AJKD 1998; 32(4):635-41.



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