Ethypharm naloxone poster on telephone booth ruled to be public advertising of a POM (AUTH/3700/10/22)

📅 2022 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3700/10/22
PartiesHealth professional v Ethypharm
MaterialPoster about naloxone displayed on the side of a telephone booth; included naloxone.org.uk
Reference / job codeUK-PREN-17
Date of preparationFebruary 2021
Complaint received22 October 2022
Case completed12 October 2023
Applicable Code year2021
Breaches upheldClauses 5.1, 26.1, 26.2
No breachClause 2 (successfully appealed)
SanctionsUndertaking received; additional sanctions not stated
Key issuePoster + linked website were considered to advertise a POM to the public and present unbalanced information likely to encourage seeking a specific formulation

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

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What happened

  • A health professional complained about an Ethypharm poster about naloxone displayed on the side of a telephone booth (REF UK-PREN-17; date of preparation February 2021).
  • The poster used prominent public-facing messaging (eg, “Carrying naloxone is easier than carrying a mate’s coffin” and “Carry naloxone. It could help save a life.”) and directed readers to naloxone.org.uk.
  • The Panel (and later the Appeal Board) considered the website address was an integral part of the poster; the website homepage (as accessed July 2023) showed images of Prenoxad (Ethypharm) and Nyxoid (another company).
  • Ethypharm argued it was a disease awareness / public health-style campaign to reduce opioid overdose deaths and noted that since 2015 naloxone could be supplied without a prescription under specific conditions (take-home naloxone), though naloxone remained a prescription only medicine (POM).
  • The certification documentation described the job as “Disease awareness on opioids overdose”, listed the product as Prenoxad, and stated dissemination included “billboards… and will be distributed via the Commercial Sales Team”; the target audience was listed as “Doctors, Other”.
  • On appeal, Ethypharm acknowledged it had “pushed the boundaries [of the Code]” and had not obtained health minister approval for the campaign.
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Outcome

  • Breach upheld: Clause 26.1 (advertising a prescription only medicine to the public) – unsuccessfully appealed.
  • Breach upheld: Clause 26.2 (unbalanced information and encouraging the public to ask for a specific POM) – unsuccessfully appealed.
  • Breach upheld: Clause 5.1 (failing to maintain high standards) – unsuccessfully appealed.
  • No breach (on appeal): Clause 2 – the Appeal Board overturned the Panel’s Clause 2 breach in the unusual circumstances of this case.
  • Sanctions recorded on the PMCPA case page: Undertaking received. (No additional sanctions stated.)
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