Key Topic 1: Encourage Rational Prescribing – Safety Information
As signatories it is easy to focus on the accuracy and substantiation of the claims before you, and forget to consider whether any other balancing statements need to be made within an asset.
Try putting yourself in the place of the health professional when you review assets and consider:
- Is there a critical piece of safety information that should be highlighted?
- Is there other important information missing that is needed to support appropriate prescribing?
- Could omission of that information potentially cause a patient safety issue?
- Does omission of any information make the statements misleading?
It seems that omission of important safety information (as well as exaggerated claims!) was common many decades ago.
But it is still a relatively common error nowadays as the following cases will show.
Example 1
Take a look at the following promotional leavepiece for a topical oestradiol gel and the boxed warning in the prescribing information for this product:
Which of the following do you agree with?
- There is appropriate balance of safety and efficacy information in this piece
- The important risks of cancer are mentioned in the piece so this is approvable
- The piece refers the reader to the boxed warning and PI so this is approvable
- The omission of risk information on this piece makes it potentially misleading
Ruling
This was the subject of an FDA warning letter due to the omission of important risk information. Although the piece contained the statement ‘estrogen therapies increase the risk of certain cancers, cardiovascular disorders and probable dementia’ the FDA said that the piece failed to disclose material information about specific cancer and cardiovascular risks in the boxed warning.
Hint and tip: remember that health professionals should not have to ‘dig out’ the important information – it should be made easy for them to take the balanced view from materials without a lot of extra work on their part.
Example 2
This is a UK example about a mailing and a detail aid for Deximune (cliclosporin) marketed by Dexcel Pharma. The SmpC for Deximune and the other brands of ciclosporin stated that patients should not be transferred to or from other oral formulations of ciclosporin without appropriate close monitoring of ciclosporin blood concentrations, serum creatinine and blood pressure.
The mailing contained two claims in bold blue font, with another statement in plain black font in between as follows:
There is no significant difference between the absorption of ciclosporin from Deximune and Neoral under fed and fasted conditions’
Because of the differences in absorption between fed and fasted conditions with the previous formulations of ciclosporin the current recommendations are for close monitoring when switching any formulation of ciclosporin.
However, patients can be started on Deximune or switched to Deximune from Neoral without the need for dose adjustment.
Which of the following do you agree with?
- The statement about monitoring is present and so this information is appropriately balanced
- The bold blue font is more likely to draw the readers attention than the plain black text this is always a matter of judgement but the Panel commented that they felt this was the case in this instance
- The statement about extra monitoring is insufficient the Panel said that it was inadequate as it failed to mention the specific requirements for blood levels, creatinine and blood pressure monitoring. Important safety information had been omitted.
- Ciclosporin is so commonly prescribed that health professionals would be aware of the monitoring requirements so this is approvable the Panel acknowledged that hospital consultants would be likely to be familiar with the monitoring requirements. However the mailing had been sent to a non specialist audience as well
Hint and tip
Always make sure that you are clear about the target audience and that it is documented
