AUTH/1901/10/06: ‘Dear Practice Nurse’ Rotarix letter sent to non-prescribers – No breach (GSK) | PMCPA Case

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Key facts

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Case number	AUTH/1901/10/06
Complainant	Primary care trust chief pharmacist/associate director of public health
Company	GlaxoSmithKline UK Ltd
Product	Rotarix (rotavirus vaccine)
Material	‘Dear Practice Nurse’ letter (ref ROT/LTR/06/26848/1c)
Main issue	Promotion sent to non-prescribers; concern prescribers did not receive information
Clauses considered	Clauses 9.1 and 12.1
Decision	No breach of Clause 12.1; no breach of Clause 9.1
Complaint received	16 October 2006
Case completed	15 December 2006
Applicable Code year	2006
Appeal	No appeal

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

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A primary care trust chief pharmacist/associate director of public health complained that a ‘Dear Practice Nurse’ letter about Rotarix (rotavirus vaccine) was sent to non-prescribers.
The complainant said practices reported that none of the information seemed to have been sent to prescribers and asked whether it was ABPI policy to target non-prescribers without providing information to prescribers.
The letter introduced Rotarix as the first gastroenteritis vaccine in Europe for infants from six weeks of age, included clinical data, the dose schedule in the context of UK routine childhood vaccinations, and information on how to order the vaccine.
GSK said the letter was part of a coordinated launch and follow-up mailing to prescribers and administrators of paediatric vaccines (including lead paediatric vaccine GPs and practice nurses).
GSK described a follow-up mailing strategy (three groups of practices) to audit responses; it acknowledged that in 52 practices a branch surgery nurse might receive the follow-up while the lead prescriber at the main surgery might not receive that follow-up, but stated the lead prescriber would have received the original launch mailing.
GSK noted ~800 accredited nurse prescribers could prescribe from a full formulary, but most nurses could not prescribe vaccines unless a patient group direction was authorised; many were involved in administration and ordering.

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