Chiesi webinar: prescribing information not readable/long enough and Trimbow described as “safe” (AUTH/3516/5/21)

📅 2021 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3516/5/21
ComplainantHealth professional (contactable)
CompanyChiesi Limited
MaterialWebinar: “Session 3: Evolving Developments in the Management of asthma”
Webinar date25 May 2021
Complaint received26 May 2021
Case completed8 February 2022
Applicable Code year2019
Breach clausesClause 4.1; Clause 7.9
No breach clauses (listed)Clause(s) 2, 4.1, 4.8, 7.2, 7.4, 9.1
SanctionsUndertaking received
AppealNo appeal
Products referencedTrimbow; Fostair
Job code/date noted by PanelUK-TRI-2100147; April 2021

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

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What happened

  • A health professional complained about a Chiesi-organised webinar (25 May 2021) titled “Session 3: Evolving Developments in the Management of asthma”.
  • Concerns included: prescribing information (PI) not present/legible; rounding of clinical data (“almost”, “approx”); “extrafine/fine particle” implications for lung deposition; missing approval code/date; comments about switching SABA devices (“low hanging fruit”); “recipe for disaster” language about mixing inhaler devices; Q&A comments encouraging guideline listing; and Trimbow being called “safe”.
  • The Panel accepted the invitation itself did not mention any Chiesi medicine and was not promotional.
  • The Panel reviewed Chiesi’s webinar recording and found the PI slides were difficult to read (slightly blurred) and displayed for too short a time to be readable.
  • In the Q&A, the presenter referred to Trimbow as “safe medicines” in a way the Panel considered related to Trimbow (not just the class), triggering a breach.
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Outcome

  • Breach found: Clause 4.1 (prescribing information in the webinar not sufficiently clear/long enough to read).
  • Breach found: Clause 7.9 (use of the word “safe” in relation to Trimbow).
  • No breach: Clause 4.1 (invitation); Clause 7.2 (terminology/rounding); Clauses 7.2 and 7.4 (extrafine/lung deposition substantiation); Clauses 4.8 and 9.1 (date of preparation/approval code issue); Clauses 2, 7.2 and 9.1 (SABA/carbon footprint comments); Clauses 2, 7.2, 7.4 and 9.1 (device-type “recipe for disaster” and guideline discussion/scaremongering allegations).
  • No breach of Clause 2 was ruled.
  • No appeal.
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