AUTH/2495/3/12: Pharmacist v ALK-Abelló (Jext vs EpiPen) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/2495/3/12
Complainant	Pharmacist
Company	ALK-Abelló Limited
Products	Jext (ALK-Abelló) and EpiPen (Meda Pharmaceuticals)
Therapy area	Anaphylaxis (adrenaline auto-injectors)
Main allegations	EpiPen said to be discontinued; Jext administration said to be identical to EpiPen; Jext said to have 24-month shelf life once at pharmacy
Applicable Code year	2011
Clauses cited	2, 7.2, 7.3, 15.2 and 15.9
PMCPA outcome	No breach
Complaint received	23 March 2012 (HTML) / 26 March 2012 (PDF)
Case completed	06 June 2012
Appeal	No appeal

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

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A pharmacist complained about alleged statements made by a named ALK-Abelló representative regarding Jext (ALK-Abelló) and EpiPen (Meda), both adrenaline auto-injectors for emergency treatment of anaphylaxis.
The pharmacist alleged the representative said EpiPen had been discontinued (it had not).
The pharmacist alleged the representative said Jext’s route of administration was identical to EpiPen’s; the pharmacist cited SPC differences (“place and push” for Jext vs “swing and jab” for EpiPen) and raised patient safety concerns.
The pharmacist alleged the representative said Jext had a 24-month shelf life once it reached the pharmacy; the pharmacist reported some stock had 14 months remaining.
ALK-Abelló denied the statements and provided detailed evidence suggesting the alleged one-to-one pharmacy meeting did not occur; it said its only contact with a pharmacist of the same initial/surname was at an LPC evening meeting in late January 2012.
The complainant maintained the interaction occurred at his pharmacy in mid-January and said he did not attend the late-January LPC meeting.

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No breach of the Code.
The Panel found, on the balance of probabilities, the complainant had not proven that a meeting took place between him and the named representative; therefore the allegations that the representative misled him were not established.
Alleged breaches of Clauses 7.2, 7.3, 15.2, 15.9 and 2 were ruled not in breach.

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