AUTH/2170/9/08: Syner-Med Ferinject brochure – misleading CosmoFer infusion time (Clause 7.2) | PMCPA Case

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Key facts

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Case number	AUTH/2170/9/08
Parties	Senior Hospital Nurse/Director v Syner-Med (Pharmaceutical Products) Limited
Product	Ferinject (ferric carboxymaltose)
Material	Two-page brochure “Anaemia Service… Redesigning Provision” (ref F09/07-05-08-045)
Main issue	Brochure presentation of CosmoFer infusion time (stated 6 hours; SPC allowed 4–6 hours) and resulting concern about correct administration
Complaint received	30 September 2008
Case completed	12 November 2008
Applicable Code year	2008
Breach clauses	Clause 7.2
Sanctions	Undertaking received
Appeal	No appeal

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

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What happened

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A senior hospital nurse complained about a two-page brochure, “Anaemia Service… Redesigning Provision” (ref F09/07-05-08-045) for Ferinject (ferric carboxymaltose), produced by Syner-Med.
The complainant said a colleague obtained the brochure at a study day in Warwick on 19 September 2008 (later clarified it was obtained from another person at the study day, not from the company stand).
The brochure stated CosmoFer 1,000mg over six hours; the complainant’s unit had administered CosmoFer 1,500mg over four hours and believed the brochure caused unfounded anxiety by implying their administration was incorrect.
The PMCPA noted the brochure appeared identical to one previously ruled on (AUTH/2149/8/08) and asked Syner-Med to respond regarding Clause 7.2 and a possible breach of undertaking under Clause 25.
Syner-Med said it had undertaken on 18 August 2008 to withdraw the brochure immediately, instructed hospital sales specialists to stop use and return stock, and isolated stock at head office pending destruction. It denied distributing the brochure after the undertaking.

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Outcome

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Breach found: Clause 7.2 (misleading information). The Panel stated the earlier ruling (AUTH/2149/8/08) covered the allegation here.
No breach found:</strong Clause 25 (breach of undertaking) – there was no evidence Syner-Med supplied the brochure after giving its undertaking to withdraw it.
No appeal.

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AUTH/2170/9/08: Syner-Med Ferinject brochure – misleading CosmoFer infusion time (Clause 7.2)

Key facts

What happened

Outcome

Clauses

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