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PMCPA Case

AUTH/2103/3/08: Anonymous PCT medicines management team member v Trinity-Chiesi – therapeutic review service (no breach)

📅 2008 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2103/3/08
Case referenceAnonymous member of a primary care trust (PCT) medicines management team v Trinity-Chiesi
ComplainantAnonymous member of a primary care trust (PCT) medicines management team
Respondent/companyTrinity-Chiesi Pharmaceuticals Ltd
Product(s)Clenil; Clenil Modulite; beclometasone (CFC and CFC-free)
Material/channelTherapeutic review service (Clinical Support Service (CSS)); associated protocols/forms and example patient letters
Key issueWhether the company facilitated a prohibited switch service (switching without clinical assessment) versus a compliant therapeutic review service
Dates (received/completed if stated)Complaint received 11 March 2008; Case completed 15 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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  • An anonymous member of a primary care trust (PCT) medicines management team complained about a programme in a practice which allegedly advocated switching from beclometasone CFC and beclometasone CFC-free to Trinity-Chiesi’s branded beclometasone CFC-free product, Clenil.
  • The complainant alleged this breached the Code prohibition on pharmaceutical companies sponsoring switch services (Clauses 18.1 and 18.4).
  • The Authority asked Trinity-Chiesi to respond in relation to Clauses 2 and 9.1 as well as Clauses 18.1 and 18.4.
  • Trinity-Chiesi stated it did not operate a switch service for Clenil and provided information about a non-promotional therapeutic review service called the Clinical Support Service (CSS), delivered by registered pharmacists under written instructions from an authorising GP.
  • CSS documentation stated the service was not linked to any particular products; representatives were briefed that they could not support a switch programme and had limited involvement (introducing the service and liaising to arrange pharmacist appointments).
  • Patients were not clinically assessed in person; CSS pharmacists reviewed individual medical records, documented any medication changes and rationale, and the authorising GP reviewed and approved changes in writing at the end of the day.
  • The Panel noted concerns from the documents: changes appeared to be made by the CSS pharmacist then authorised later by the GP; a Medication Summary Form suggested the review could appear product-led; and some example patient letters appeared to anticipate switches to Clenil Modulite.
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Outcome

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  • The Panel found no evidence that the CSS acted as a prohibited switch service where patients were simply switched from one medicine to another without clinical assessment.
  • No breach was ruled in relation to Clauses 18.1 and 18.4.
  • No breach was ruled in relation to Clauses 2 and 9.1.
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