Chiesi SOP training criticised as a ‘tick-box’ validation exercise ahead of PMCPA audit (AUTH/2741/12/14)

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Key facts

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Case number	AUTH/2741/12/14
Parties	A representative v Chiesi
Issue	SOP training and validation for a primary care sales team; alleged “tick-box” approach and answer changes
Training date	October 2014
Complaint received	19 December 2014
Case completed	12 February 2015
Published	May 2015 Code of Practice Review
Applicable Code year	2014
Delegates	Eight attendees (named in complaint; one former contractor declined interview)
SOPs referenced as trained (company account)	UK-SOP-0007 (recall of materials); UK-SOP-0010 (handling on- and off-label requests for information); UK-SOP-0013 (meetings organised by field force personnel); UK-SOP-0237 (material distribution); UK-SOP-0247 (use of electronic communication by salesforce); UK-SOP-0253 (use of consultants and speakers)
Validation approach	Formal MCQ tests for UK-SOP-0010 (7 questions) and UK-SOP-0013 (13 questions); other SOPs validated verbally
Breaches	Clause 9.1
No breach	Clauses 2, 15.1, 16.1
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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A representative complained about SOP training for a primary care sales team run by a regional business manager (RBM) in October 2014, shortly before a PMCPA audit.
The complainant alleged the session was presented as a “tick box exercise to get [the PMCPA] off [Chiesi’s] backs”, was rushed, and that delegates were effectively encouraged to change answers on multiple-choice validation tests so everyone scored 100%.
Chiesi investigated, interviewed delegates and the RBM (one former contractor declined), and denied the “tick box” framing and any instruction to change answers.
The Panel focused on whether the training/validation approach maintained high standards and whether it was adequate and Code-compliance focused.
The Panel noted delegates were trained on six SOPs (three updated; three new). Only two SOPs were formally validated via MCQs; the other SOPs (including three new ones) were validated verbally.
The Panel also noted the running order/agenda provided did not include validation of the meetings SOP (UK-SOP-0013), and queried whether the MCQ validation was sufficiently rigorous given the length of the SOP and guidance notes.
Marked papers showed 100% scores, but several papers appeared to show amended answers; the Panel found insufficient evidence to support the allegation that “all” delegates changed answers or that “most” failed.

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Breach of Clause 9.1 (high standards not maintained) in relation to inadequate validation of the six SOPs, which on the balance of probabilities amounted to a tick-box exercise.
No breach of Clause 16.1 (training to help representatives comply with the Code) because training had been given.
No breach of Clause 15.1 (adequate training) because the complainant had not shown the SOP training was inadequate.
No breach of Clause 2 (bringing discredit) because overall the training was not such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry.
No appeal.

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