AUTH/3036/4/18: Health professional v Concordia (Morphgesic SR journal ad) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/3036/4/18
Complainant	Anonymous contactable ‘concerned UK health professional’
Company	Concordia International Rx (UK) Limited
Product	Morphgesic SR 10mg tablets (modified release morphine sulphate)
Material	Journal advertisement in Pulse (April 2018), ref Con/MOR/PM/0021
Main issue	Allegation that prescribing information was outdated (interpreted as “from May 2013”)
PI dates in ad	Date of preparation: May 2013; Date of revision: December 2017
Ad date of preparation	February 2018
SPC date referenced	Last updated May 2015 (per company submission)
Clauses considered	2, 4.1, 9.1
Decision	No breach
Complaint received	25 April 2018
Case completed	12 July 2018
Appeal	No appeal
Applicable Code year	2016

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

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An anonymous contactable UK health professional complained about a journal advertisement for Morphgesic SR 10mg modified release morphine sulphate (ref Con/MOR/PM/0021) published in Pulse, April 2018.
The complainant alleged the prescribing information (PI) in the ad was “from May 2013” and therefore unusually old.
The complainant referenced SPC updates in 2014 (including medicines and driving warnings) and 2015 (multiple SPC sections and corresponding PIL sections), alleging the ad’s PI could be out of step with current knowledge and put patients at risk.
The PMCPA asked the company to consider Clauses 2, 4.1 and 9.1.
Concordia stated the PI was last updated December 2017, aligned to the latest SPC (last updated May 2015), and that “May 2013” was the original creation date, not the last revision date.

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