AUTH/2144/7/08 Nurse v Syner-Med: Question at a meeting (no breach)

📅 2008 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2144/7/08
Case referenceQuestion at a meeting
ComplainantNurse
Respondent/companySyner-Med (Pharmaceutical Products) Limited
Product(s)Venofer (injectable iron preparation; iron sucrose)
Material/channelSponsored lunchtime educational meeting/symposium at British Renal Society conference; open Q&A session
Key issueAlleged impression that an EpiPen could replace cardio-pulmonary resuscitation procedures when administering iv iron in the community
Dates (received/completed if stated)Complaint received 17 July 2008; case completed 16 September 2008
AppealNot stated
Code year2006 Code (considered under 2008 Constitution and Procedure)
Breaches/clausesNo breach of Clauses 7.2, 7.9, 7.10
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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Reviewed by Dr Anzal Qurbain (FFPM) β€” ABPI Final Signatory

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What happened

  • A nurse complained about a lunchtime educational meeting/symposium organised/sponsored by Syner-Med at the British Renal Society (BRS) meeting.
  • The complaint related to a Q&A discussion about safety issues of giving intravenous (iv) iron in the community.
  • According to the complaint, a delegate said they had addressed this by sending people away with an EpiPen (adrenaline injection), and the speaker and Syner-Med representatives did not comment, allegedly giving the impression that cardio-pulmonary resuscitation (CPR) procedures could be replaced with an EpiPen.
  • Syner-Med stated the symposium (100+ delegates) was titled β€œAnaemia in chronic kidney disease: The future of iv iron treatment”, lasted 60 minutes, and included three presentations followed by questions.
  • Syner-Med said the question was general, not product-specific and not directed at its part-time consultant speaker; a nurse delegate answered based on local experience with EpiPens in home haemodialysis.
  • The Panel noted Syner-Med sponsored the meeting; one speaker acted as a part-time consultant to Syner-Med; Syner-Med supplied slide templates to two speakers; and ten Syner-Med staff attended.
  • The Panel noted one slide referred to iv iron sucrose, but the presentation appeared to be about anaemia management rather than Venofer specifically.
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Outcome

  • The Panel noted the Venofer SPC warned that parenteral iron can cause potentially fatal allergic/anaphylactoid reactions and that treatment for serious allergic reactions and facilities with established CPR procedures should be available.
  • The Panel considered it might have been helpful if someone had reminded the audience about CPR during the EpiPen discussion.
  • However, because it was impossible to know the exact question/answer and context, the Panel concluded that on the balance of probabilities the audience was not left with the impression that an EpiPen could replace CPR as alleged.
  • No breach of the Code was ruled.
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