AUTH/3392/10/20 - Complainant v Stiefel

Prescribing information for Toctino

  • Received
    01 October 2020
  • Case number
    AUTH/3392/10/20
  • Applicable Code year
    2019
  • Completed
    11 March 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about prescribing information for Toctino (alitretinoin) placed on the Guidelines in Practice website by Stiefel. Toctino was indicated for use in adults who had severe chronic hand eczema that was unresponsive to treatment with potent topical corticosteroids.

The complainant noted that the Toctino prescribing information (link provided) was created in 2016, which was also when the material was prepared. The complainant doubted that the prescribing information had been rechecked since then and there had been six updates to the summary of product characteristics (SPC) since 2016 which had included alterations to most sections – including special warnings. Further, there was no black triangle present, which was required for Toctino which was a patient safety issue.

The detailed response from GlaxoSmithKline is given below.

The Panel noted GlaxoSmithKline’s submission that it had commissioned a GP e-learning module at the end of 2017 but that it decided not to proceed with the project, which was subsequently cancelled as confirmed by the publisher. The content was therefore never approved to go live by GlaxoSmithKline and the promotional material and associated prescribing information should not have been published on the third-party website. The publisher had, however, without GlaxoSmithKline’s knowledge and against its express instructions, created standalone prescribing information and posted it on the Guidelines in Practice portal on 18 February 2018. It appeared from the material provided by GlaxoSmithKline that the hosting page was certified on 23 February 2018.

An email from the publisher stated that the project was cancelled at a face-to-face meeting with GlaxoSmithKline on 8 August 2018. The email stated that the e-learning project was to be ended and that the e-learning module needed to be removed from the publisher’s website. The email further stated that someone from the publisher should confirm that this had been done. According to the email, the publisher emailed the GlaxoSmithKline employee to confirm that the e-learning module had been removed from the website.

The Panel noted that the material should not have been available after 8 August. It appeared that both parties agreed that the project was cancelled by 8 August 2018. No written confirmation from GlaxoSmithKline to the publisher regarding the company’s decision not to proceed with the project was provided.

It appeared that the Toctino prescribing information was made live in error by the publisher before the project was cancelled and the publisher had not removed it following cancellation of the project in August 2018.

The Panel noted that the complainant had not provided details of which updates to the SPC, in his/her view, had warranted changes to the prescribing information at issue; GlaxoSmithKline had made no submission in this regard except to state that the requirement for the addition of a black triangle only became necessary in July 2018 following a regulatory update and that GlaxoSmithKline had updated the Toctino prescribing information in July 2018 to include a black triangle.

As GlaxoSmithKline was unaware of the existence of the prescribing information in question on the Guidelines in Practice website, this was not updated. The Panel noted that the prescribing information in question therefore did not include a black triangle when it became necessary in July 2018, which was prior to the project being cancelled, and up until the material was removed at the time of the complaint (September 2020) and was thus out-of-date. The Panel therefore ruled breaches of the Code.

The Panel noted the circumstances of this case and considered that GlaxoSmithKline had been badly let down by the third party working on its behalf. As a result of the publisher, the out-of-date prescribing information for Toctino, which should not have been published in the first place, was available for over two years. The Panel noted its comments and rulings above and considered that high standards had not been maintained. A breach of the Code was ruled.

The Panel noted its rulings and comments above and that GlaxoSmithKline had taken immediate steps to ensure removal of the material from the third party website as soon as it was discovered. The Panel did not consider that the particular circumstances warranted a ruling of a breach of Clause 2 which was a sign of particular censure and reserved for such use.