Employee complaint: Otsuka Europe/Otsuka UK delays updating SPCs, eMC and prescribing information (Jinarc, Samsca, Abilify)

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Key facts

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Case numbers	AUTH/3041/6/18 (Otsuka Europe) and AUTH/3042/6/18 (Otsuka UK)
Parties	Employee v Otsuka Europe and Otsuka UK
Issue	Updating prescribing information / implementation of SPC changes; delays updating eMC; withdrawal/recertification of materials; RMP educational materials not promptly updated/submitted to MHRA
Products	Jinarc (tolvaptan), Samsca (tolvaptan), Abilify (aripiprazole), Abilify Maintena (aripiprazole LAI)
Complaint received	1 June 2018
Applicable Code year	2016
Breaches found	Clauses 2, 4.1, 9.1
No breach findings (in parts)	Some allegations under Clauses 4.1 and 9.1 were not established in specific instances (e.g., certain SPC updates not shown to require PI changes; one Jinarc interaction update handled within timelines)
Appeal Board outcome	Public reprimands; audits and multiple re-audits; later no further action required after progress evidenced (January 2022 re-audits)
Undertakings received	AUTH/3041/6/18 – 7 February 2019; AUTH/3042/6/18 – 8 February 2019
Case completed	10 March 2022

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

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An Otsuka employee complained that processes for updating SPCs and prescribing information were inadequate, leading to delayed communication/implementation and potential patient safety risk.
Products involved: Jinarc (tolvaptan), Samsca (tolvaptan), Abilify (aripiprazole) and Abilify Maintena (aripiprazole LAI; co-promoted in the UK with Lundbeck).
Key issues included delays in updating the electronic medicines compendium (eMC), delays updating/withdrawing promotional materials, and failure to promptly update MHRA-approved risk minimisation plan (RMP) educational materials.
Governance weaknesses included unclear accountability between Otsuka Europe and Otsuka Europe Development and Commercialisation for communicating SPC/PIL changes to Otsuka UK, and notifications being sent to the wrong person or to individuals on leave rather than a designated regulatory inbox.
Otsuka’s own review covered 1,407 “job bags” and identified items missing prescribing information, items with incorrect/out-of-date prescribing information, and RMP materials not updated after SPC changes.
The Panel was concerned that Otsuka provided incorrect information about when a Jinarc dose reduction recommendation (for moderate CYP3A inhibitors including fluconazole) first appeared in the SPC (it appeared to have been present since May 2015).

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Breaches were found (not a “no breach” case overall).
Otsuka UK: multiple breaches for failures to maintain high standards (including delays updating eMC; delays updating/withdrawing materials; missing/out-of-date prescribing information; delayed RMP updates) and a breach of Clause 2 for cumulative governance failures with potential patient safety implications.
Otsuka Europe: breaches for Jinarc website materials with out-of-date prescribing information, missing prescribing information in Abilify Maintena materials, poor governance/high standards failures, and Clause 2 for cumulative effect.
Both Otsuka Europe and Otsuka UK were reported to the Appeal Board due to breadth/depth of compliance difficulties.
Appeal Board imposed public reprimands and required audits and multiple re-audits; ultimately (after January 2022 re-audits) no further action was required provided improvements continued.

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