AUTH/3210/6/19: Patient v GlaxoSmithKline — peak flow diary alleged to be out of date (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3210/6/19
Complainant	Anonymous, non-contactable individual (described him/herself as an asthma patient)
Company	GlaxoSmithKline UK Limited
Material	Peak flow diary (patient support item), ref UK/RESP/0111a/12(2) July 2016
Main allegation	Material appeared not to have been certified in the last two years; alleged failure to recall out-of-date materials
Certification / recertification	Certified 5 October 2016; recertified 4 October 2018 (no changes required)
GP surgery order detail	60 diaries ordered from company website in April 2018
Clauses cited	2, 9.1, 14.5
Panel decision	No breach of the Code
Complaint received	20 June 2019
Case completed	6 September 2019
Appeal	No appeal
Published	May 2020 Code of Practice Review
Applicable Code year	2019

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

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An anonymous, non-contactable individual who described him/herself as an asthma patient complained about a GlaxoSmithKline (GSK) peak flow diary given at a named GP surgery.
The diary carried a date of preparation “July 2016” (ref UK/RESP/0111a/12(2) July 2016).
The complainant alleged the material appeared not to have been certified in the last two years and was surprised GSK did not recall out-of-date materials from GP practices.
GSK stated the item was a patient support item for adult patients to monitor peak flow pressure; it was certified for use on 5 October 2016 and recertified on 4 October 2018 with no changes required.
GSK explained it did not update the printed “date of preparation” when recertifying without changes, as changing it would require recall/reprint with no benefit.
GSK said the GP surgery ordered 60 diaries from the company website in April 2018.
GSK also addressed that Asthma UK had changed a telephone number; a voice message redirected callers to the new number and the diary included a current email address.

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