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PMCPA Case

AUTH/2097/2/08: Teva v Trinity-Chiesi – Clinical support service pharmacist forms (no breach)

📅 2008 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2097/2/08
Case referenceTRCSS20040235 (forms reference)
ComplainantTeva UK Limited
Respondent/companyTrinity-Chiesi Pharmaceuticals Ltd
Product(s)Clenil Modulite; Qvar (mentioned); CFC-containing beclometasone pMDIs (eg, Beclazone, Becotide, Becloforte) (mentioned)
Material/channelTwo CSS pharmacist forms/letters to community pharmacists (dated 2 and 24 October 2007)
Key issueWhether CSS forms improperly promoted Clenil Modulite / implied an assisted switch, used professional status inappropriately, or evidenced inducement or a service limited to sponsor products
Dates (received/completed if stated)Complaint received 14 February 2008; case completed 22 April 2008
AppealNot stated
Code yearNot stated
Breaches/clausesNo breach of Clauses 2, 9.1, 18.1, 18.4
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

Download the full case report (PDF)

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

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What happened

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  • Teva UK Limited complained about Trinity-Chiesi Pharmaceuticals Ltd’s Clinic Support Service (CSS), focusing on two CSS pharmacist forms (ref TRCSS20040235) dated 2 and 24 October 2007.
  • The forms, signed by a pharmacist in Trinity-Chiesi’s CSS team, were headed “For the attention of the pharmacist” and were sent as advisory notes to help community pharmacists plan stock levels.
  • Each form stated there was a “Likely INCREASED use of” Clenil Modulite (CFC-free beclometasone dipropionate, BDP) and referenced reduced use of CFC-containing beclometasone inhalers (wording varied by form).
  • Teva argued the forms lacked customer (GP) signature/endorsement and did not show what work had been done or whether changes were agreed with GPs, and alleged the wording (“Dear colleague”, “a fellow pharmacist”) improperly used professional status and implied an assisted switch to Clenil Modulite.
  • Teva also argued the forms suggested the service was limited to the sponsor’s medicines, contrary to requirements for a genuine therapeutic review.
  • Trinity-Chiesi responded that the forms were advisory letters between health professionals, used to inform community pharmacists of likely outcomes of a GP-authorised CSS conducted in the surgery; no customer signature was needed because no action was required by the community pharmacist.
  • Trinity-Chiesi stated the CSS was a therapeutic review/clinical assessment activity authorised by GPs, with any clinical queries/recommendations discussed directly with the authorising GP and documented elsewhere (not on the community pharmacist advisory form).
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Outcome

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  • The Panel noted the complaint was made solely on the basis of the two forms provided.
  • The Panel found the pharmacists in Trinity-Chiesi’s CSS team were employees of the company (not “sponsored healthcare professionals”).
  • The Panel considered the forms were not sufficiently clear about the role of the pharmacists employed by Trinity-Chiesi, and that community pharmacists would not necessarily view a company-employed pharmacist as a “colleague”.
  • On the narrow basis of the complaint, the Panel did not consider the lack of customer endorsement on the forms provided clear evidence that the service was a switch to Clenil Modulite rather than a therapeutic review.
  • The Panel ruled no breach of Clause 18.4.
  • The Panel also ruled there was no evidence, based on the two forms, that the service as a whole was limited to Trinity-Chiesi products; no breach of Clause 18.4 was ruled on that basis as well.
  • Given no breach of Clause 18.4, the Panel ruled no breach of Clause 18.1, and also ruled no breach of Clauses 2 and 9.1.
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