AUTH/3526/6/21 - Voluntary admission by Leo

Broken prescribing information links on promotional Innohep emails

  • Received
    25 June 2021
  • Case number
    AUTH/3526/6/21
  • Applicable Code year
    2019
  • Completed
    26 August 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

Leo Pharma UK voluntarily admitted that in promotional emails for Innohep (tinzaparin) sent out to UK health professionals, the links to the prescribing information were broken. Innohep was an anticoagulant indicated for the treatment and prophylaxis of thrombotic events in certain adults.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Leo.

Leo submitted that promotional emails for Innohep contained a URL hyperlink to the prescribing information on a website, www.innohep.co.uk, which was provided by way of a clear and prominent direct single click link.

Leo stated that on 8 March, a new website, which had merged www.innohep.uk and its sister website www.innohep.ie, was pushed live, and the previous websites taken down.

On 17 March, during approval of a new promotional email, it was noted that the URL hyperlink to the prescribing information was inactive as a result of being broken during the website upgrade work.

Leo stated that between 8 to 17 March, six promotional emails with broken prescribing information links were sent out and health professionals clicking on the links would have been unable to access the prescribing information during that time.

Leo admitted that the sending of a promotional email with broken prescribing information breached the requirement that prescribing information must be provided for all digital promotional material for a medicine either by inclusion in the material itself or by way of a clear and prominent direct single click link. Leo acknowledged responsibility for not checking the links following the website upgrade, and therefore regrettably voluntarily admitted breaches of the Code.

The detailed response from Leo is given below.

The Panel noted that each of the six email templates at issue was headed with: ‘This is a promotional email intended for UK healthcare professionals only. Click here for adverse event reporting and prescribing information’ or ‘This is a promotional email from Leo Pharma. This event is intended for UK health professionals only. Click here for adverse events and prescribing information’.

The Panel noted Leo’s submission that when the emails were approved for use, the ‘Click here’ link which connected to the website www.innohep.co.uk was active but that when that website was merged in March 2021 with www.innohep.ie and the now combined website went live, the link was broken, thus preventing readers from accessing the prescribing information. The Panel noted that between 8 and 17 March 2021, six promotional emails with broken prescribing information links were sent out to UK health professionals.

The Panel noted that in the case of digital material, the prescribing information could be provided either in the digital material itself or via a clear and prominent direct single click link. The Panel noted that in the emails in question, that single click link was broken and breaches of the Code were ruled as acknowledged by Leo.

The Panel noted the circumstances of this case and considered that Leo would have been well advised to have tested the links to the new combined website at the outset, given that prescribing information was an important contributor to patient safety. In that regard, the Panel considered that high standards had not been maintained and a breach of the Code was ruled. Overall, the Panel did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and reserved for such. No breach of Clause 2 was ruled.