AUTH/3111/10/18 - Complainant v Pfizer

Legibility of prescribing information

  • Received
    29 October 2018
  • Case number
    AUTH/3111/10/18
  • Applicable Code year
    2016
  • Completed
    08 March 2019
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2019 Review

Case Summary

A contactable complainant, who described him/ herself as a concerned UK health professional, alleged that the prescribing information on Pfizer’s PfizerPro website for Xeljanz (tofacitinib), Sutent (sunitinib) and Champix (varenicline) was very difficult to read and that there might be other examples.

The detailed response from Pfizer appears below.

The Panel noted that Clause 4.1 required that prescribing information be given in a clear and legible manner and the supplementary information listed recommendations to help achieve clarity.  The Panel noted that the prescribing information at issue was published on a website and therefore the recommendations in the Code needed to be considered in the context of digital material. 

The Panel noted Pfizer’s submission that the prescribing information font size on the pages in question was such that all lower-case characters were approximately 2mm in size when viewed via Google Chrome on a standard desktop device under the default factory zoom setting of 100%.  The Panel also noted Pfizer’s submission that line-spacing and font-type were selected to facilitate easy reading and that the font-colour was dark grey on a white background and emboldened headings were used at the start of each section.

The Panel noted Pfizer’s submission that the website at issue had been designed so that the character line length was determined by the size and orientation of the device screen or window being used as well as the viewer’s personal zoom settings applied on his/her device.  The Panel noted Pfizer’s submission that for the prescribing information identified by the complainant, the average line character length, with factory zoom settings enabled, ranged from approximately 50 characters on a small smart phone to approximately 100 characters on a desktop device.  The Panel noted Pfizer’s submission that the text line length might occasionally exceed 100 characters on a desktop device, however, given the other legibility measures in place, Pfizer did not consider that this would impact the overall ease of reading the prescribing information on the website.

The Panel noted that the complainant had provided links to the webpages in question, however, he/ she did not provide information regarding what device (smart phone, tablet, desktop) he/she had used to read the information and its settings.  Nor had the complainant explained why he/she found the prescribing information difficult to read.  The Panel noted that the screenshots provided by Pfizer appeared to be of the webpages as viewed from a desktop. 

The Panel had some concerns with regard to the impact of the character line length when viewed from a desktop device, and the use of grey coloured font, on ease of readability.

The Panel considered that, on balance, based on the evidence before it, the prescribing information for Xeljanz, Sutent and Champix on the webpages at issue was on the limits of acceptability in terms of legibility and no breach of the Code was ruled.

The Panel noted that the complainant stated that there might be other examples of medicines where the prescribing information was difficult to read and that the entire site should be reviewed.  The Panel noted Pfizer’s submission that it had reviewed the prescribing information provided across the PfizerPro website and had not been able to identify any legibility issues.  The Panel noted that the complainant had the burden of proving his/ her complaint on the balance of probabilities.  All complaints were judged on the evidence provided by the parties.  The complainant had provided no evidence to support his/her allegation regarding other medicines and no breach of the Code was ruled in this regard.