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PMCPA Case

Otsuka Europe voluntary admission: delayed affiliate notification of Samsca SPC and prescribing information updates (AUTH/3489/3/21)

📅 2021 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/3489/3/21
CompanyOtsuka Pharmaceutical Europe Limited
ProductSamsca (tolvaptan)
IssueDelayed notification to affiliates of SPC revision and delayed provision of updated prescribing information (missed SOP timelines)
SOP/system referencedEU-SOP-MA-002; CREDO regulatory documents management system
Key dates (process)Health authority approval received 22 Dec 2020; communicated to Medical Affairs 28 Dec 2020; affiliate notification due 4 Jan 2021 but sent 8 Jan 2021; updated prescribing information disseminated 18 Jan 2021; revised SPC published on eMC 13 Jan 2021
Complaint received11 March 2021
Case completed04 January 2022
Applicable Code year2019
Breach clauses2; 9.1; 29
SanctionsUndertaking received; Additional sanctions: Advertisement
AppealNo appeal

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

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What happened

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  • Otsuka Pharmaceutical Europe made a voluntary admission about delays in notifying affiliates of an updated Samsca (tolvaptan) summary of product characteristics (SPC/SmPC) and associated prescribing information.
  • The relevant SOP (EU-SOP-MA-002) set timelines for communicating SPC revisions via the CREDO system (including affiliate acknowledgement and withdrawal of impacted materials).
  • Health authority approval of the SPC revision was received on 22 December 2020 and communicated to Otsuka Europe Medical Affairs on 28 December 2020 (within SOP timelines).
  • Affiliate notification should have been sent by close of business on 4 January 2021 but was not sent until 8 January 2021.
  • Two staff members formally raised concerns internally that SOP timelines were not being followed.
  • The prescribing information wording was impacted by the SPC revision, but updated prescribing information was not provided to affiliates until 18 January 2021.
  • Context included a vacant therapy area lead role (nephrology) covered by a senior medical staff member who was on annual leave, with no deputy nominated; the senior staff member also did not have the appropriate CREDO rights to initiate the notification until assistance was sought on 8 January.
  • Otsuka stated Samsca was not promoted in the UK and argued the delay in prescribing information did not impact Code-scoped activity; the Panel noted UK availability could still mean non-promotional materials might be affected.
  • The Panel also noted a separate, investigated communication about an anticipated Jinarc SPC revision (4 February 2021) that used an incorrect template and a working practice not followed (PI review committee did not review the full draft PI vs the entire agreed English SPC); no evidence of recipient confusion was found, but the Panel expressed concern about senior staff not following procedures.
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Outcome

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  • Breach of Clause 9.1 ruled for failure to promptly notify affiliates of the SPC change and to promptly provide updated prescribing information in accordance with the SOP.
  • Breach of Clause 29 ruled because the Clause 9.1 breach meant Otsuka Europe breached an undertaking given in a previous case (Case AUTH/3041/16/18) relating to prompt communication of SPC updates.
  • Breach of Clause 2 ruled because the breach of undertaking brought discredit upon, and reduced confidence in, the pharmaceutical industry.
  • No appeal.
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