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PMCPA Case

Otsuka Europe & Otsuka UK: Abilify Maintena prescribing information omitted monthly dosing frequency (breach of undertaking)

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numbersAUTH/3565/10/21 (Otsuka Pharmaceutical Europe Limited); AUTH/3566/10/21 (Otsuka Pharmaceuticals (UK) Limited)
CompanyOtsuka Pharmaceutical Europe Limited; Otsuka Pharmaceuticals (UK) Limited
ProductAbilify / Abilify Maintena (aripiprazole)
IssueOmission of dosing frequency (“monthly”) for intramuscular maintenance dosing in prescribing information; breach of undertaking
Applicable Code year2019
Clauses breachedClause 2; Clause 9.1; Clause 29
PI approval datesOtsuka Europe: 30 October 2020; Otsuka UK: 9 November 2020
When first identified11–12 August 2021 (QC checker at Otsuka Europe)
Recall completedOtsuka Europe: 20 August 2021; Otsuka UK: 25 August 2021
UK PromoMats withdrawal16 September 2021 (delay stated to be due to an oversight)
Complaint received1 October 2021
Case completed16 February 2022
AppealNo appeal
SanctionsUndertaking received; Additional sanctions: Advertisement
Related prior cases referencedAUTH/3041/6/18 (Otsuka Europe); AUTH/3042/6/18 (Otsuka UK)

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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  • Otsuka Pharmaceutical Europe Limited (AUTH/3565/10/21) and Otsuka Pharmaceuticals (UK) Limited (AUTH/3566/10/21) made a joint voluntary admission about incorrect prescribing information (PI) for Abilify/Abilify Maintena (aripiprazole).
  • The PI omitted the frequency of dosing (“monthly”) for the intramuscular maintenance regimen for Abilify Maintena.
  • The omission appears to have been introduced during an October 2020 PI revision following an SPC update (addition of a two-injection start initiation method).
  • Contrary to SOP EU-SOP-MA-002, the Prescribing Information Review Committee (PIRC) did not meet until after the European Commission final decision; governance and documentation were poor and meeting minutes were silent on the key change.
  • The PI was approved in PromoMats by Otsuka Europe on 30 October 2020 and by Otsuka UK on 9 November 2020; the omission was not identified at either approval stage.
  • Further opportunities to detect the error were missed, including certification/QC checks of UK digital materials (the PI was included in seven Otsuka UK digital materials at the time of withdrawal).
  • The issue was first noticed on 11–12 August 2021 by a QC checker at Otsuka Europe while reviewing materials for a conference (ECNP preparation).
  • An Incident Response Team met on 16 August 2021 and agreed withdrawal/recall of the PI from affiliates and impacted materials within five working days.
  • Otsuka Europe completed recall on 20 August 2021; Otsuka UK completed recall of materials on 25 August 2021. The PI was withdrawn from UK PromoMats on 16 September 2021 (delay described as “due to an oversight”).
  • The companies said they could not establish with certainty why the omission occurred (staff changes, inconsistent recollections, poor meeting documentation).
  • Both companies considered the matter similar to earlier cases (AUTH/3041/6/18 and AUTH/3042/6/18) and therefore a breach of undertakings given in those cases.
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Outcome

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  • Breach found in relation to both companies.
  • Incorrect PI and process failures were ruled to be failures to maintain high standards.
  • The matter was ruled to bring discredit upon, and reduce confidence in, the pharmaceutical industry.
  • Both companies were ruled to have breached prior undertakings (considered separately for Otsuka Europe and Otsuka UK).
  • The Panel was extremely concerned about the breach of undertaking but decided not to report the companies to the Appeal Board under Paragraph 8.2 at that time (noting proportionality and that audits from earlier cases were ongoing).
  • No appeal.
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