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PMCPA Case

Otsuka: Jinarc training portal wording and aRMM guide omission found misleading (AUTH/3751/3/23)

📅 2023 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/3751/3/23
ComplainantEx-employee (could not be contacted on the details provided)
CompanyOtsuka Pharmaceuticals UK Limited
Medicine / materialJinarc (tolvaptan) training website; Healthcare Professionals Educational Guide (aRMM)
Issue(s)Contradictory portal wording about enrolment/registration to prescribe; omission of CKD warning/precaution from educational guide list of “special warnings and precautions for use”
Applicable Code2021
Breach clausesClause 6.1; Clause 5.1; Clause 2
SanctionsUndertaking received; Advertisement
Complaint received13 March 2023
Case completed20 June 2024
AppealNo appeal
Sourcehttps://www.pmcpa.org.uk/cases/completed-cases/auth3751323-ex-employee-v-otsuka

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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  • An ex-employee complained about the Jinarc (tolvaptan) UK training portal wording, saying it implied HCPs must register details to be eligible to prescribe, while also stating enrolment was “not mandatory”.
  • The portal text included: “Healthcare professionals must also register their details… allowing them to become certified prescribers eligible to prescribe Jinarc”, alongside a footnote saying Step 2 (enrolment) was not mandatory to prescribe, and further wording: “please complete the enrolment form to become a JINARC® prescriber”.
  • The complainant also alleged the Healthcare Professionals Educational Guide (part of additional Risk Minimisation Measures (aRMM)) omitted a special warning/precaution from the SmPC relating to Chronic Kidney Disease (CKD), including discontinuation if renal insufficiency progresses to CKD stage 5.
  • Otsuka said the MHRA had previously required a controlled distribution model (including tracking trained prescribers), later removed in 2020, but MHRA requested continued tracking for audit trail and refresher training reminders.
  • Otsuka acknowledged the website instructions could have been clearer and accepted a breach for ambiguity on the portal; it denied that the educational guide omission breached the Code, noting MHRA approval and that the guide was not intended to replicate the SmPC.
  • The Panel noted the CKD warning appeared in SmPC Section 4.4 and was also referenced in Section 4.2; the educational guide listed “special warnings and precautions for use” but did not include the CKD warning anywhere in the 11-page guide.
  • The Panel also noted Otsuka’s internal review had identified the missing CKD precaution and a request was made to add it, but a consensus meeting decided not to amend, including because MHRA had already approved the material.
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Outcome

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  • Jinarc training portal: Breach ruled for misleading/contradictory instructions about whether enrolment/registration was required to prescribe.
  • Healthcare Professionals Educational Guide (aRMM): Breaches ruled for misleading omission of a relevant CKD warning/precaution; failure to maintain high standards; and bringing discredit upon/reducing confidence in the industry (patient safety context, black triangle medicine, aRMM materials).
  • No appeal.
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