AUTH/2413/6/11: Leo – Xamiol film clip mistakenly included on Tysabri patient DVD (promotion to the public) | PMCPA Case

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Key facts

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Case number	AUTH/2413/6/11
Company	Leo Pharma
Product	Xamiol Gel (calcipotriol/betamethasone)
Third party / context	Biogen Idec Tysabri (natalizumab) patient DVD
Issue	Xamiol promotional film clip inadvertently included on a patient DVD distributed to health professionals and patients
How identified	Courtesy call from Biogen Idec (15 June 2011); voluntary admission by Leo
Volumes	1,014 DVDs produced; 760 in warehouse; 254 assumed distributed; total defective DVDs unknown
Complaint received	24 June 2011
Case completed	05 August 2011
Applicable Code year	2011
Breach clauses	Clause 22.1
Non-breach clauses considered	Clause 9.1; Clause 2
Sanctions	Undertaking received
Appeal	No appeal

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

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Leo became aware (15 June 2011) that a promotional film clip showing application of Xamiol Gel (calcipotriol/betamethasone) for scalp psoriasis had been inadvertently included on a Biogen Idec Tysabri (natalizumab) patient DVD.
The Tysabri DVD had originally been approved in April 2010 and produced correctly by one production company; in March 2011 production switched to a new agency and 1,014 DVDs were produced containing the Xamiol clip.
760 DVDs were still in a warehouse; the remaining 254 were assumed to have been distributed (the total number of defective DVDs was uncertain).
The Xamiol clip had been sent to the agency by Leo’s Head Office in Denmark (Nov/Dec 2010) under a confidentiality agreement with destruction instructions; the clip had never been used in the UK by Leo.
Biogen Idec planned a recall from health professionals and Biogen Idec representatives, but not from patients; Leo insisted all defective DVDs be recalled and destroyed and requested a destruction certificate.
The DVD containing the Xamiol clip was distributed to patients and did not include prescribing information or adverse event reporting advice when given to health professionals.
Leo made a voluntary admission/self-report to the PMCPA due to the risk of promotion to patients and inadequate accompanying information.

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Breach of Clause 22.1 was ruled (promotion of a prescription only medicine to the public).
No breach of Clause 9.1 was ruled (high standards).
No breach of Clause 2 was ruled.
No appeal.

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