GSK voluntary admission: promotional email for Trelegy Ellipta used out-of-date prescribing information (AUTH/3257/10/19)

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Key facts

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Case	AUTH/3257/10/19
Company	GlaxoSmithKline UK Limited
Type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Product	Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)
Material	Sponsored promotional email (ref PM-GB-FVU-EML-190028); corrective email ref PM-GB-FVU-EML-190043
Main issue	Out-of-date prescribing information embedded in the email (Nov 2017 used; current SPC Nov 2018)
Key SPC changes noted	Broader indication (added patients not adequately treated by LABA+LAMA); added adverse events (bronchitis, sinusitis, urinary tract infection, dysphonia, constipation, dry mouth); candidiasis of mouth and oropharyngeal pain frequency moved from uncommon to common
Send date	16 September 2019
Error identified	17 September 2019 (by a GSK medical signatory)
Corrective action	Corrective email initially sent 23 September 2019; all recipients received corrective email on 3 October 2019
Reach/engagement (reported)	Opened by 1,487 GPs; 35 clicked through
Complaint received	09 October 2019
Completed	17 December 2019
Breach clauses	Clause 4.1; Clause 9.1
Sanction	Undertaking received
Appeal	No appeal
Applicable Code year	2019

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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GlaxoSmithKline (GSK) voluntarily admitted that a sponsored promotional email for Trelegy Ellipta (ref PM-GB-FVU-EML-190028) sent on 16 September 2019 contained prescribing information dated November 2017 (out-of-date).
The current SPC at the time was dated November 2018; the outdated prescribing information omitted newly added/common adverse events and reflected an older indication.
The error was identified the next day (17 September 2019) by a GSK medical signatory.
Because the original email could not be recalled, GSK arranged a corrective email (ref PM-GB-FVU-EML-190043) with correct prescribing information to be sent on 23 September 2019.
On 3 October 2019, GSK discovered its agency had only sent the corrective email to GPs who had opened the original email; GSK then asked for the corrective email to be sent to all original recipients. All recipients received the corrective email on 3 October (17 days after the original send).
GSK stated the issue arose when a previously approved/model email was repurposed/edited and the embedded prescribing information was not updated (human error). Certain individuals were retrained/reminded of processes.
Internal investigation: the email was opened by 1,487 GPs and 35 clicked through to further information; GSK stated no other emails had been sent with out-of-date prescribing information.

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Breach of Clause 4.1 ruled.
Breach of Clause 9.1 ruled.
No ruling was made with regard to Clause 4.2 (despite GSK acknowledging a breach of 4.2), because the Panel treated the failure to provide the required prescribing information as a breach of Clause 4.1.
Sanction recorded: Undertaking received.
Case completed 17 December 2019; no appeal.

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