BMJ  2005;331:293 (30 July), doi:10.1136/bmj.331.7511.293

Letter

Dose adjustment in renal impairment

Response from AHFS Drug Information

The first 150 words of the full text of this article appear below.

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 in stimulating this research.1 Thus, whether studies . . . [Full text of this article]

Gerald K McEvoy, editor

AHFS Drug Information American Society of Health-System Pharmacists, 7272 Wisconsin Avenue, Bethesda, MD 20814, USA gmcevoy@ashp.org


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Relevant Article

Systematic comparison of four sources of drug information regarding adjustment of dose for renal function
Liat Vidal, Maya Shavit, Abigail Fraser, Mical Paul, and Leonard Leibovici
BMJ 2005 331: 263. [Abstract] [Full Text] [PDF]

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