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PMCPA Case

AUTH/3151/1/19: Anonymous employees v Otsuka Europe – SPC update confusion and incorrect Jinarc prescribing information

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/3151/1/19
PartiesAnonymous employees v Otsuka Pharmaceuticals Europe Ltd
ProductJinarc (tolvaptan)
IssueSPC update communications/timelines confusion; incorrect prescribing information certified and distributed; lack of clear process for PI/SPC updates
Key date (communication)21 December 2018
Complaint received24 January 2019
Case completed16 October 2019
Applicable Code year2016
Clauses breached2, 9.1
No breachClause 4.1
SanctionsUndertaking received; Additional sanctions; Advertisement

Download the full case report (PDF)

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

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What happened

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  • A group of anonymous employees complained about Otsuka Europe’s handling of updates to the Jinarc (tolvaptan) SPC and prescribing information, following an SPC-related email sent on 21 December 2018.
  • The 21 December 2018 communication included affiliate actions and timelines (business days plus completion dates) for distributing updated SPC/leaflet, withdrawing previous materials, and updating non-promotional materials.
  • The timelines caused confusion because the stated “business days” did not appear to match the completion dates; additional “non-working days” (24 and 31 December) were used but were not clearly covered in the SOP or widely communicated.
  • A senior employee also incorrectly referred to the change as “the Jinarc SmPC change regarding gout,” adding to confusion.
  • Incorrect Jinarc prescribing information (November and December 2018 versions) was certified and distributed internally to affiliates; it omitted previously added SPC updates (CKD stage 4 indication extension, abdominal pain as a common side effect, and acute liver failure warnings/adverse events).
  • Complainants also alleged lack of a central repository and lack of a standard process for creating/updating prescribing information, plus concerns about distribution lists, leadership understanding, global oversight, and organisational culture.
  • Otsuka Europe accepted that the prescribing information sent on 21 December 2018 was inconsistent with the revised SPC, but stated it was not used externally; it also acknowledged broader process failings and slow remediation after earlier cases.
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Outcome

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  • Breach of Clause 9.1 for confusion caused by unclear communication about implementation timelines for a critical SPC update process.
  • Breach of Clause 9.1 for certifying and widely distributing incorrect prescribing information omitting important safety information and a change to the licensed indication (even though there was no evidence it was used externally in materials in this case).
  • Breach of Clause 9.1 for lack of a clear process/oversight for creation and revision of prescribing information and SPC updates.
  • No breach of Clause 4.1 (no evidence/allegation that incorrect prescribing information was actually used in materials in this case).
  • Clause 2: Panel initially ruled no breach; on appeal, the Appeal Board ruled a breach of Clause 2 due to the cumulative effect of the failings reducing confidence in the pharmaceutical industry.
  • Other allegations (distribution list omissions, alleged meeting comments about “testing affiliates”/legal privilege, global oversight, and blame culture) were not upheld due to insufficient evidence/burden of proof not discharged.
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