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Comparison of Package-insert Recommendations for Renal Dosing and Prescribed Dosing of Products Containing Tenofovir: The VA Experience
Barbara Phillips*, P Belperio, L Mole, and V Katseva
Ctr for Quality Mgmt in Publ Hlth, Veterans Hlth Admin, Palo Alto, CA, US
Background: Tenofovir (TFV) and the co-formulated
product, emtricitabine/tenofovir (FTC/TFV) require dose adjustment for patients
with renal impairment. We examined adherence of Veterans Health Administration
(VA) prescribers to Food and Drug Administration (FDA) -approved
recommendations for renal dosing for these 2 products.
Methods: Veterans who filled an outpatient
prescription for TFV or FTC/TFV during 2004 or 2005 were identified from the
VA’s national Clinical Case Registry. To measure prescribed dose, we coded
units per dose and dosing interval from the SIG (dosage interval) for each
prescription and calculated total daily dose from these measures. To determine
recommended dose, we: estimated creatinine clearance (CrCle) using the
Cockcroft-Gault algorithm with ideal weight and the result of the serum
creatinine test drawn on or most closely preceding the fill date; and
identified receipt of dialysis from the SIG and diagnosis and procedure codes
dated within 30 days of the fill date. We compared prescribed and recommended
dose and calculated descriptive statistics, overall and by level of renal
impairment.
Results: More than 9700 veterans filled over 120,000
VA prescriptions for TFV or FTC/TFV during 2004 or 2005. About 4300 of these
prescriptions (3.6%) were filled by veterans whose CrCle was below 50 mL/minute,
of which 309 were filled by veterans documented as receiving dialysis. About
88% of fills by those receiving dialysis were for the recommended total daily
dose; however, that was the case for only 21% of fills for other veterans with
CrCle <50 mL/minute. Almost all of the difference between prescribed and
recommended total daily dose related to errors in dosing interval. Overall,
about 7% of the 9700 veterans filled at least 1 prescription during 2004 or
2005 that was inconsistent with the dosing recommendation.
Conclusions: Normal adult dosing is indicated for
the great majority (96%) of veterans who fill a TFV or FTC/TFV prescription. However,
unless they are receiving dialysis, veterans who require renal dosing usually
are not prescribed the recommended dose. Efforts should be made to educate
prescribers on dosing these 2 products and other antiretroviral products that
require dose adjustment for patients with renal impairment, and tools should be
made available to assist prescribers to readily identify patients who require
renal dosing.
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