Dose adjustment in renal impairment: Response from AHFS Drug Information

EDITOR—For almost 50 years American Hospital Formulary System Drug Information (AHFS DI) has had the most widely vetted, evidence based process for content development of any drug compendium in the US—a process that is not limited to the professional labelling (package insert) approved by the Food and Drug Administration (FDA) but includes extensive ongoing review and professional analysis of the medical literature identified through resources such as PubMed (Medline).1 2

Vidal et al's criticisms should have been directed principally at the inadequacies of the drug regulatory processes and pharmaceutical manufacturers in researching and publishing such information rather than at the drug information publishers (p 263).3 In the US the FDA does not require manufacturers to conduct research establishing the impact of renal function on dosing. Instead an FDA guidance document merely provides opinion and advice and carries no regulatory force …