Implementation of Pharmaceutical Care Services in a Renal Dialysis Unit

Cynthia A. Naughton, Pharm.D., M.S.

Heartland Health System
North Dakota State University College of Pharmacy
Fargo, North Dakota

Managing patients with chronic kidney disease (CKD) is frequently complex due to the presence of multiple medical conditions along with renal impairment. Dialysis patients generally exhibit numerous concurrent problems, either due to or as a consequence of their renal failure. Associated medical problems include diabetes mellitus, hypertension, anemia, hyper or hypocalcemia, hyperphosphatemia, secondary hyperparathyroidism, infectious processes, and cardiovascular morbidity.

Pharmacotherapy management of CKD patients has been optimized through the addition of pharmaceutical care to the already existing medical, nursing, dietary, and social work care plans. The pharmaceutical care service began in 1998 and initially consisted of erythropoietin dosing. The service has now grown to include the following:

• Medication history upon admission
• Quarterly drug regimen review
• Maintenance of a computerized patient database
• Renal dosing service
• Erythropoietin dosing protocol management
• Iron dosing protocol management
• Vitamin D dosing protocol management
• Patient and family education
• Participation in monthly care conferences with attending nephrologists, and
• Collaboration with the transplant team

The Heartland Health Systems Kidney Dialysis Unit is a regional, ambulatory dialysis facilities servicing approximately 110 hemodialysis and 30 peritoneal dialysis patients. The average daily census is 55 patients. Prior to implementing a pharmaceutical care service, pharmacy services were purely distributive functions. The pharmacy supplied the erythropoietin, heparin, iron dextran, and calcitriol injection without looking at appropriateness of therapy or monitoring.

In 1997 the National Kidney Foundation released their Dialysis Outcomes Quality Initiative (DOQI) Clinical Practice Guidelines on Anemia Management. The consensus document targeted a hematocrit range of 33-36% to improve patient outcomes and survival. The Health Care Finance Administrations (HCFA) also announced changes to Medicare reimbursement. Reimbursement for erythropoietin would be denied if a patient’s average hematocrit exceeded 36.5%. At the time erythropoietin was the number one pharmaceutical in dollars spent at Heartland. The cost was $10 per 1000 units, the typical patient dose was 10-12,000 units/week (range 1000-30,000 units), and approximately $50,000 worth of erythropoietin was used per month in the kidney dialysis unit.

The clinical and financial impact was great and an erythropoietin use evaluation was conducted. Criteria included the percent of patient in DOQI target hematocrit range (33-36%) and the percent of patients with a hematocrit exceeding 36.5%. The results were 40% of patients were below target range, 30% were within the target hematocrit range of 33-36%, and 30% were above the 36.5% hematocrit. With 30% of the patients exceeding a hematocrit of 36.5%, it was projected that $16,000 per month would be lost revenue in denied Medicare claims with the current dosing practice.

A performance improvement team consisting of physicians, nursing, pharmacy, and finance were convened to study the problem and identify alternatives to the current practice of physician directed erythropoietin dosing and monitoring. From this group a pharmacy managed EPO dosing protocol was developed, approved, and implemented in January 1998. Pharmacy also supplied erythropoietin in unit dose syringes to minimize waste and coordination with finance department for reimbursement was established.

The new EPO protocol was evaluated for medical and finance outcomes after 12 months. The percentage of patients within the DOQI target hematocrit range of 33-36% with the new protocol consistently exceeded the baseline value of 30%. Also the percent of patients exceeding an average hematocrit greater than 36.5% declined from 30% to an average of 8.0% and there were no Medicare denials for erythropoietin.

Due to the success of the EPO project, other opportunities were explored to expand services in the kidney unit. A telephone survey of renal units was conducted in the surrounding states. About 25% of the pharmacy’s provided some pharmaceutical services which turned out to be predominately antibiotic dosing.

Service opportunities were identified for pharmaceutical care at Heartland including:

• Anemia management
• Medication management
• Identification and resolution of drug related problems
• Calcium and phosphorous balance management
• Hyperparathyroidism management
• Patient and Family Education
• Transplant therapeutics

Hospital administration supported the idea of adding pharmaceutical care services to the kidney unit as long as no additional staff needed to be hired. An application for a grant was written and awarded by the Dakota Medical Foundation to fund a pharmacy resident. Pharmaceutical care services were implemented when the pharmacy resident started at the facility. Pharmaceutical care services were provided initially to hemodialysis patients only and have now been expanded to the peritoneal dialysis population also.

The pharmacy resident position was instrumental in implementing the program. The resident helped design the computerized database capable of generating current medication profiles which were then placed in the medical record. A rotating calendar of patient appointments was generated so that all patients would meet with a pharmacist upon admission and then quarterly for drug regimen review. In the first year alone, 131 drug related problems were identified during the patient appointments.

Drug related problems identified in dialysis patients
(from July 2000-June 2001.)

Problem	Frequency (%)
Untreated Indication	45 (34.3%)
Indication with an Incorrect Drug	21 (16%)
Adverse Drug Reaction	14 (10.7%)
Failure to Receive or Take a Drug	10 (7.6%)
Incorrect Timing	10 (7.6%)
Drug without an Indication	8 (6.1%)
Sub-therapeutic Drug Dose	8 (6.1%)
Therapeutic Duplication	8 (6.1%)
Drug Overdose	7 (5.3%)

Services were expanded in the first year of pharmaceutical care services to include the development and implementation of a pharmacist managed iron dosing protocol and a pharmacist managed Vitamin D dosing protocol.