AUTH/2835/4/16: Janssen voluntary admission over outdated Invokana prescribing information email (No breach)

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Key facts

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Case number	AUTH/2835/4/16
Company	Janssen-Cilag Ltd
Product	Invokana (canagliflozin)
Material / channel	Promotional email to general practitioners
Issue	Outdated prescribing information included due to agency resending an older withdrawn mailer from archived “sent items”
Company action	Voluntary admission; corrective send issued the next day with current prescribing information and subject line noting the error
Complaint received	13 April 2016
Case completed	13 May 2016
Applicable Code year	2016
Clauses considered	Clause 4.1
Decision	No breach
Appeal	No appeal
Additional sanctions	None stated

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

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Janssen-Cilag’s mailing agency inadvertently sent general practitioners a previously withdrawn promotional email for Invokana (canagliflozin) (ref PHGB/VOK/1015/0078) containing outdated prescribing information.
Invokana prescribing information had been updated in December 2015 to add/reflect the uncommon side effect “renal failure (mainly in the context of volume depletion)” and to consolidate related uncommon renal-failure-associated side effects previously listed.
On 7 January, the agency confirmed old versions of prescribing information had been deleted from its systems; both parties assumed this meant the old promotional item was no longer available.
On 16 March, there was an email exchange about the “Invokana Cost Change email”, but neither side referenced the updated item or its reference number.
The agency’s account team verbally instructed its IT team to “resend” the mailer; IT retrieved the old mailer from the mail server “sent items” archive and resent it on 22 March.
On 23 March, the agency sent the correct version with current prescribing information (ref PHGB/VOK/1015/0078(1)a) and a subject line highlighting the previous version was sent in error.
Janssen proactively contacted the PMCPA; under Paragraph 5.6 of the Constitution and Procedure, the voluntary admission was treated as a complaint.

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No breach of the Code was ruled.
The Panel ruled no breach of Clause 4.1.
The Panel considered that although the prescribing information was not the most up-to-date version, prescribers were given the substance of the relevant SPC information as required.
The Panel noted both Janssen and the agency should have been clearer about which item was to be sent, given the importance of not sending outdated material.

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