Napp: opioid conversion messaging on Targinact website/leavepiece found misleading (AUTH/2256/8/09)

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Key facts

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Case number	AUTH/2256/8/09
Complainant	Health and Social Care Board prescribing adviser
Company	Napp Pharmaceuticals Limited
Product	Targinact (prolonged release oxycodone and naloxone)
Channel/material	Website presentation (www.targetingpain.co.uk) incl. Slide 7; printed leavepiece (UK/TA-09105); FAQ document/booklet (UK/TA-08046); rep flyer (UK/FT-09044)
Main issue	Unqualified opioid conversion/switch messaging (“Instead of … co-codamol…”, “Instead of … tramadol…”) implying simple substitution
Applicable Code year	2008
Complaint received	06 August 2009
Case completed	05 October 2009
Appeal	No appeal
Breach clauses	Clause 7.2 (x2), Clause 7.3 (x2), Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A health and social care board prescribing adviser complained about a Targinact (prolonged release oxycodone/naloxone) presentation on a Napp-sponsored website (www.targetingpain.co.uk).
Slide 7 (“How to prescribe Targinact tablets”) stated a starting dose of Targinact 10mg/5mg 12-hourly and, in the same highlighted box, used the wording “Instead of … codeine, 8 x 30mg/500mg co-codamol tablets/day” and “Instead of … tramadol 200mg/day”.
The complainant alleged this implied equivalent efficacy and a simple switch, which was misleading and could prejudice patient safety; they also noted the slide did not state Targinact was a Schedule 2 controlled drug.
The Panel considered the website FAQ section contained more context (guide only, titration needed, assumptions listed), but the slide itself presented the conversion information without qualification and had to stand alone.
Printed material was also reviewed: a leavepiece (UK/TA-09105) repeated the slide’s message with a small-print footnote (“This is a guide only…”), a FAQ booklet (UK/TA-08046) provided fuller qualifying context, and a rep flyer (UK/FT-09044) simply signposted the website.

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Breach: Slide 7 on the website was ruled misleading due to unqualified “instead of” conversion messaging (Clauses 7.2 and 7.3).
Breach: The leavepiece (UK/TA-09105) was also ruled misleading; the small-print footnote did not negate the overall impression (Clauses 7.2 and 7.3).
No breach: The Panel did not make an additional breach ruling on patient safety beyond the misleading finding.
No breach: Not stating on the slide/leavepiece that Targinact was a controlled drug was not ruled misleading per se (legal classification was available in prescribing information via hyperlink).
No breach: The FAQ document (UK/TA-08046) was not misleading on conversion because it clearly stated the table was a guide and highlighted titration and assumptions.
No breach: The rep flyer (UK/FT-09044) was not misleading as it did not include conversion comparisons.
Breach: High standards were not maintained overall (Clause 9.1).
No breach: Clause 2 was not applied (Panel said it was reserved for particular censure and not warranted here).

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