Janssen voluntary admission: Trevicta journal ads missing PI location reference and incomplete hardcopy certification (AUTH/2870/8/16)

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Key facts

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Case number	AUTH/2870/8/16
Company	Janssen-Cilag Ltd
Product	Trevicta (paliperidone palmitate 3 monthly)
Material type	Two-page journal advertisements (PI overleaf)
Ad references	PHGB/XEP/0516/0022; PHGB/XEP/0516/0022a; PHGB/XEP/0516/0022b; PHGB/XEP/0616/0015
Where placed	The Commissioning Review; BMJ; Nurse Prescribing; Prescriber; British Journal of Mental Health Nursing; British Journal of Psychiatry; Progress in Psychiatry
Issue	Missing reference on first page to where PI could be found (PI was overleaf); final hardcopy form not certified
Root cause (as described)	Job bags incorrectly uploaded into Zinc as digital-only, leading to electronic-only certification and missed final hardcopy check
Complaint received	10 August 2016
Case completed	23 August 2016
Applicable Code year	2016
Breach clauses	Clause 4.7; Clause 14.1
Sanctions	Undertaking received
Appeal	No appeal

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

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Janssen-Cilag Ltd placed four two-page Trevicta (paliperidone palmitate 3 monthly) journal advertisements during July and August 2016.
The prescribing information (PI) appeared overleaf on the second page, but the first page omitted the required reference stating where the PI could be found.
The omission was not detected during Janssen’s copy approval/certification process.
An internal review found the job bags had been incorrectly uploaded into Zinc as “digital” job bags, even though the ads were both digital and hard copy.
As a result, the ads were electronically certified only and were not also certified in their final hardcopy form.
Janssen proactively notified the PMCPA (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure).

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