Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs

Abstract

A number of important drugs used to treat cancer—many of which serve as the backbone of modern chemotherapy regimens—have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.

The CredibleMeds® list: Usage of QT interval prolonging drugs in Germany and discordances with prescribing information

“…The problem of outdated or contradicting prescribing information was shown in the past in several studies for different therapeutic areas. [42][43][44][45] A systematic investigation on inconsistencies in prescribing information in the UK, US and German drug market revealed that reciprocal warnings regarding drug-drug interactions were frequently missing in more than 40 % of the cases. 46 A study from the UK observed major differences between the prescribing information and scientific guidelines for Attention Deficit Hyperactivity Disorder (ADHD) medicines.…”

“…43 A recently published commentary emphasized several considerations for the FDA on how to update outdated prescribing information and labelling of oncology drugs to ensure their relevance for clinical practice. 44 A study from 2014 screened European drug labels for the term 'QT' and concluded that for 43 % of the SmPCs that mentioned QT prolongation a clear statement was missing on whether the drug induced QT prolongation. 45 In our present study using CredibleMeds ® as QT reference database, we detected inadequate information in 33.0 % of German SmPCs and 53.3 % of US PI.…”