Shortcomings in Descriptions of Drug Package Inserts Regarding Drug Administration for Patients with Decreased Renal Function

Abstract

The dosage and administration of renally excreted drugs to patients with decreased renal function need to be optimized in accordance with their renal function. However, drug package inserts do not necessarily have sufficient information. Therefore, we identified and classified the issues regarding this lack of information and investigated the percentage of affected package inserts. We investigated 341 oral drugs in the Clinical Practice Guidebook of Chronic Kidney Disease 2012. 1. The shortcomings in the description of urinary excretion parameters, which is needed for dose adjustment in accordance with renal function, are classified as follows: (1) unchanged drugs and metabolites are not indicated (28％, 95/341), (2) bioavailability for oral dosage is not taken into account (84％, 286/341), and (3) sufficient recovery time for urinary excretion is not acknowledged (3.5％, 12/341). 2. With respect to the dosage regimen of renally excreted drugs, the following information was absent: (1) dosage and dosing interval in accordance with renal function are not described (63％, 70/111) and (2) considerations for dose reduction are not provided (32％, 36/111). 3. A major shortcoming in the description of drug administration for anuric dialysis patient is that nephrotoxic drugs, such as, nonsteroidal anti-inflammatory drugs, are described as being contraindicated (100％, 11/11). We found that the current information in package inserts of several drugs is insufficient to understand the required dose adjustment or the correct method of administration to patients with decreased renal function. We aim to improve the information in drug package inserts to allow for effective and safe pharmacotherapy.