AUTH/2969/8/17: Senior Practice Nurse v AstraZeneca — governance failures in call recording and “permission to call back” | PMCPA Case

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Key facts

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Case number	AUTH/2969/8/17
Complainant	Senior practice nurse (lead diabetes nurse)
Company	AstraZeneca UK Limited
Product	Forxiga (dapagliflozin)
Issue type	Conduct of a representative; governance of calls/contacts and CRM recording
Complaint received	3 August 2017
Case completed	26 January 2018
Applicable Code year	2016
No breach clauses	Clause 2; Clause 7.2; Clause 7.4; Clause 8.1; Clause 15.4; Clause 15.9
Breach clauses	Clause 9.1; Clause 15.2
Sanction	Undertaking received
Appeal	No appeal

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

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A senior practice nurse complained about the conduct of an AstraZeneca UK medical representative promoting Forxiga (dapagliflozin) for type 2 diabetes.
The nurse alleged repeated unbooked “self-presentations” at reception, insistence on being seen while the nurse was with patients, and an attempted discussion in a corridor.
The nurse alleged the rep said patients should be switched from canagliflozin (Invokana) to Forxiga due to surveys linking canagliflozin to increased lower limb amputation risk, and that the rep disparaged canagliflozin.
AstraZeneca denied the key behavioural and promotional allegations, stating the interaction was brief and professional and that any discussion would have been consistent with SPC wording and reactive materials.
The Panel could not determine exactly what was said in the corridor interaction (accounts differed) and noted the complainant bore the burden of proof.
However, the Panel identified serious governance concerns: reliance on unrecorded verbal consent to classify calls as “solicited”, unclear internal guidance, and poor/inaccurate CRM call recording (including “group call” categorisation issues and blank call records).

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No breach of Clause 2, Clause 7.2, Clause 7.4, Clause 8.1, Clause 15.4, Clause 15.9.
Breach of Clause 9.1 (company failed to maintain high standards due to governance weaknesses around permission to call back and call/contact recording).
Breach of Clause 15.2 (representative failed to maintain high standards due to poor governance regarding call recording and lack of detail).
Sanction recorded: Undertaking received.
No appeal.

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