AUTH/1872/7/06: Hospital Chief Pharmacist/Director v Shire – use of previously criticised ‘taste/acceptability’ paper (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/1872/7/06
Parties	Hospital Chief Pharmacist/Director v Shire
Issue	Alleged breach of undertaking; continued use/distribution of Rees and Howe paper to promote Calcichew-D3 Forte
Product	Calcichew-D3 Forte
Material at issue	Rees and Howe (2001) peer-reviewed paper on acceptability/preference vs Adcal-D3
Related prior case	AUTH/1825/4/06 (misleading advertisement referencing the study)
Clauses considered	2, 7.2, 7.3, 9.1, 22
Decision	No breach
Complaint received	28 July 2006
Case completed	5 September 2006
Appeal	No appeal
Published	November 2006 Code of Practice Review

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

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A hospital chief pharmacist alleged Shire was still using a “paper on taste” to promote Calcichew-D3 Forte, despite a prior ruling (AUTH/1825/4/06) that an advertisement referencing the paper was misleading.
The paper was said to be shown to GP practices to encourage prescribing and circulated to hospital drug and therapeutics committees to support formulary inclusion.
Because this raised a potential breach of an undertaking, the matter was taken up by the PMCPA Director (Authority responsibility for undertakings).
The underlying publication (Rees and Howe, 2001) reported a randomised controlled crossover trial comparing acceptability of Calcichew-D3 Forte vs Adcal-D3, including organoleptic attributes and overall preference.
Shire stated the earlier case related to claims in an advertising leaflet, not to distributing reprints of the paper itself, and argued the Code permitted distribution of peer-reviewed publications (Clause 11.1 referenced by Shire).

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No breach of the Code was ruled.
The Panel found that providing the actual paper gave recipients sufficient detail to understand what patients preferred and why.
The Panel found use of Rees and Howe was not a misleading comparison and did not breach the earlier undertaking.

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