Clinical pharmacist v AstraZeneca

Identifying patients suitable for Forxiga treatment and failing to provide an accurate response to the Panel

Corrective statement​​

Dear Healthcare Professional,

Corrective Statement

Case AUTH/2793/9/15: Identifying patients suitable for Forxiga treatment

 

I am writing to you as I understand that your Practice uses the EMIS Web Clinical System.

AstraZeneca produced a leavepiece entitled '9 step guide to identify your uncontrolled and overweight patients with type 2 diabetes (T2D) who may be suitable for treatment with dapagliflozin EMIS Web Instructions' (ref 716.131.011). AstraZeneca markets Forxiga®▼ (dapagliflozin) which is indicated to improve glycaemic control in certain type 2 diabetic patients. You may have been provided with a copy of the leavepiece sometime between 19 May 2015 and 13 November 2015.

Following a complaint under the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry, the Code of Practice Panel ruled that the leavepiece was misleading, it was inconsistent with the Forxiga summary of product characteristics as following the 9 step guide could lead to patients being identified as suitable for Forxiga treatment based solely on their weight and not on HbA1c levels. Forxiga is not indicated for weight loss. The Panel considered that high standards had not been maintained. Subsequently the complainant brought to light that AstraZeneca had provided inaccurate information. As a result of this and other governance issues that subsequently emerged, the Panel reported AstraZeneca to the Code of Practice Appeal Board. The Appeal Board was concerned that use of the leavepiece might lead to the inappropriate prescription of Forxiga, and it considered that it was important that recipients of the leavepiece should be made aware of this. As a result AstraZeneca has been required to issue this corrective statement and to refer to the published report for the case which contains full details.

AstraZeneca takes its responsibilities under the ABPI Code seriously and is disappointed at these failings. As an organisation we will take all steps needed to ensure this is not repeated.

 

Best regards,

* * * * * *

On 15 June 2016, AstraZeneca sent the company's corrective statement to recipients of the leavepiece at issue.

Date posted 15 June 2016​