Bausch & Lomb breached ABPI Code over Pulse “Quick Guide” on anaphylaxis: disguised promotion and misleading dose/needle depth claims

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Key facts

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Case	AUTH/2796/9/15
Complainant	Health professional (GP and GP trainer with an interest in allergy)
Company	Bausch & Lomb
Publication/material	Pulse “Quick Guide” laminated A4 insert: “New approaches in management and treatment of anaphylaxis” (ref EME-UK-1507-04, prepared July 2015); Emerade advertisement on reverse
Medicine	Emerade (adrenaline)
Main issues	Material resembled independent editorial content; misleading STMD claim; misleading/unclear dosing statements (BNF reference and 500mcg suitability), with potential patient-safety impact
Complaint received	24 September 2015
Case completed	11 December 2015
Applicable Code year	2015
Breach clauses	2, 7.2, 7.4, 7.10, 9.1, 12.1
No breach clauses (as recorded)	7.2, 7.4, 7.11
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal

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

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A GP complained about a laminated A4 “Pulse Quick Guide” titled “New approaches in management and treatment of anaphylaxis”, supplied with Pulse.
The guide discussed adrenaline auto-injectors (AAIs) (needle length, skin-to-muscle depth (STMD), dosing and cost) and had a full-page Emerade advertisement on the reverse.
The complainant alleged the piece looked like an independent Pulse article but was promotional, and challenged several statements as unscientific/misleading (including STMD and 500mcg dosing references).
The Panel found the company funding disclosure (“Initiated, developed, and funded by Bausch & Lomb”) was not prominent and could be missed; the overall impression could be that it was independent editorial content.
The Panel found certain clinical statements (STMD and dosing) were misleading/unclear and could lead to inappropriate prescribing, including potential prescribing of 500mcg where contraindicated in children.

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Breach found: Clauses 2, 7.2, 7.4, 7.10, 9.1 and 12.1.
No breach (on specific points): Clause 7.11 (use of “new” alleged as “new guidelines” not used/implied); and certain aspects under Clauses 7.2 and 7.4 relating to shelf-life/cost-per-annum presentation were not found misleading/unsupported.
No appeal.

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