AUTH/2945/3/17: Community Pharmacist v GlaxoSmithKline (COPD pharmacist booklet) – No breach

📅 2017 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/2945/3/17
ComplainantAnonymous, non contactable community pharmacist
CompanyGlaxoSmithKline
MaterialNPA booklet: Managing COPD in the community, Resources for pharmacists (Ref UK/RET/0007/16)
Main allegationsMisleading/bias; implied off-label COPD promotion via “Evohaler”; omission of other devices
Key issue“Evohaler” listed as an example MDI in a COPD devices table; concern it could imply Seretide Evohaler licensed for COPD
Panel decisionNo breach of the Code
Clauses considered3.2, 7.2, 7.3, 9.1
Complaint received13 March 2017
Case completed28 June 2017
Applicable Code year2016

Download the full case report (PDF)


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

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What happened

  • An anonymous community pharmacist complained about an NPA booklet, Managing COPD in the community, Resources for pharmacists (Ref UK/RET/0007/16), which carried both NPA and GlaxoSmithKline (GSK) logos.
  • The booklet was written/developed by the NPA; GSK funded it and checked scientific accuracy for any GSK products mentioned.
  • The complainant alleged the booklet was misleading and biased for use in Medicine Use Reviews (MURs) and New Medicine Service (NMS) consultations with COPD patients.
  • Concern focused on a table of “COPD inhaler devices” listing “Evohaler” as an example of a standard MDI, which the complainant said could be interpreted as implying Seretide Evohaler was licensed for COPD (it was not).
  • The complainant also alleged bias because some devices (eg Ellipta, Spiromax, NEXThaler, Forspiro) were not referenced.
  • GSK stated the booklet was non-promotional in content (generic names used), but had been certified as “Promotional” because it formed part of a wider partnership programme; GSK said it had not proactively distributed the booklets.
  • GSK noted Ventolin Evohaler and Seretide Evohaler were not licensed for COPD, while Serevent Evohaler was; and that a footnote in the table stated licensed indications vary and SPCs should be checked.
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Outcome

  • No breach of the Code was ruled.
  • No breach of Clause 3.2 (promotion of unlicensed indication) was ruled.
  • No breach of Clause 7.2 (misleading) was ruled.
  • No breach of Clause 7.3 (unfair comparison/misleading) was ruled.
  • No breach of Clause 9.1 (high standards) was ruled.
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