AUTH/3303/1/20 - Anonymous complainant v Vifor

Ferinject Website

  • Received
    23 January 2020
  • Case number
    Anonymous complainant v Vifor
  • Applicable Code year
    2019
  • Completed
    03 August 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, contactable individual complained about the Vifor Pharma UK website for Ferinject (ferric carboxymaltrose) (ferinject.co.uk, ref UK-FCM-1900320, September 2019). Ferinject was indicated for the treatment of iron deficiency when oral iron preparations were ineffective or could not be used.

The complainant alleged that there were several problems with the Ferinject website which stemmed from a lack of understanding of the core principles of the Code and not using medical signatory input.

The homepage of the website which was intended for health professionals who treated iron deficiency and iron deficiency anaemia contained the brand logo and an indication which made the page promotional and therefore should have had prescribing information available for health professionals. In addition, there should have been an adverse event reporting box. If the page was viewed as non-promotional (difficult to do so as the branded colour logo and indication gave promotional texture), then the adverse event box for patients was also missing and the page promoted to the public.

If visitors to the website stated that they were a health professional and clicked through to ferinject.co.uk/health-professional, the adverse events box was missing yet again and none of the pages for health professionals had adverse event reporting wording either.

A claim that ‘Ferinject is easy to administer’ could not be substantiated and was not accurate as the IV infusion required a large number of steps including dilution and choosing appropriate concentrations which made it complex to administer in addition to the close monitoring of the patient needed. Further, the administration times for different doses were different and so it was not straightforward. The complainant alleged that the claim was misleading and not accurate.

One of the pages claimed ‘Simplified dosing and administration for all patients with Ferinject’. However, the summary of product characteristics (SPC) stated that ‘The use of Ferinject has not been studied in children, and therefore is not recommended in children under 14 years’. The age restriction in the Ferinject licence was not listed anywhere on the page and so if readers only read this page it was a misleading claim.

The complainant noted that none of the patient pages had adverse event reporting statements. The only page which mentioned side effects for patients (ferinject.co.uk/patient/side-effects), stated ‘If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed on the Patient Information Leaflet’. However, this was not consistent with the wording required.

The detailed response from Vifor is given below.

The Panel noted that the landing page of the Ferinject website included the Ferinject logo in the top right hand corner and was headed ‘Welcome to Ferinject.co.uk’ followed by ‘This website is intended for healthcare professionals who treat iron deficiency and iron deficiency anaemia in adults or patients who have been prescribed this medication. Please select one of the following:’. The options given were ‘I am a healthcare professional’; ‘I am a patient who has been prescribed Ferinject’ and ‘I am neither of the above’.

The Panel noted that the open access website landing page, whilst not aimed at the public would potentially be seen by a broad audience including members of the public. The Panel noted that the landing page was a mechanism to direct three potential audiences (health professionals, patients taking Ferinject and the public) to information relevant to each audience. This was not unacceptable so long as the webpage complied with the Code and was suitable for the general public. The Panel noted that landing page included the branded Ferinject logo and mentioned treatment in iron deficiency and iron deficiency anaemia in adults. In the Panel’s view, the landing page promoted a prescription-only medicine to the public and a breach was ruled.

The Panel noted that a landing page which was openly accessible to the general public and therefore not limited to a health professional audience should not be promotional and therefore prescribing information and other obligatory information which must be provided when promoting to health professionals was not required. The Panel therefore ruled no breaches of the Code.

Similarly, noting its comments above with regard to the landing page being a mechanism to direct three potential audiences including patients taking Ferinject to information relevant to them, the Panel did not consider that the landing page was aimed specifically at patients prescribed Ferinject and therefore information for patients about how to report adverse events was not relevant and no breach was ruled in relation to the landing page.

The Panel noted that the section of the website intended for patients prescribed Ferinject (Ferinject website – Patient – iron Deficiency page (ref UK-FCM-1900009) included a tab entitled ‘Side Effects’ at the top of the homepage which took readers, via a direct single click, to a page (Ferinject website – Patient – Side Effects page (ref UK-FCM-1900018) that included, under the heading ‘Reporting side effects in the UK’, a statement with regard to how to report adverse events in line with the requirements of the Code. The Panel therefore ruled no breach. The Panel noted the complainant’s concern that if visitors to the website stated that they were a health professional and clicked through to ferinject.co.uk/health-professional, the adverse events box was missing and none of the pages for health professionals included the adverse event reporting wording. The Panel noted that the top of the homepage of the health professional section of the website included a number of tabs including one titled ‘Prescribing Information’. The Panel noted that that page included that: Adverse events should be reported followed by reporting forms and information can be found at www.mhra.gov.uk/yellowcard (and the corresponding Irish details) and that adverse events should also be reported to Vifor Pharma UK Ltd with a telephone number provided. As the required information about reporting adverse events was included within the prescribing information tab, the Panel ruled no breach of the Code.

The Panel noted the complainant’s allegations that the claim ‘Ferinject is easy to administer’ (on ferinject.co.uk/healthcare-professional (ref UK-FCM-1800089, January 2019)) was misleading and could not be substantiated. The Panel noted Vifor’s submission that the claim was in fact that Ferinject was ‘simple to administer’ and in that regard Vifor noted that a patient’s dose of iron could be calculated in one of two ways: using the Ganzoni formula or a simplified dosing table and the dosing of Ferinject according to its SPC was based on the simplified table exclusively. The Panel considered that the calculation of an iron dose was different to the administration of a dose. In responding to this allegation Vifor only referred to the calculation of the dose and not its administration.

According to its SPC, Ferinject should only be administered when staff trained to evaluate and manage anaphylactic reactions were immediately available, in an environment where full resuscitation facilities could be assured and the that the patient should be observed for adverse effects for at last 30 minutes following each Ferinject administration. The posology of Ferinject followed a stepwise approach including: (1) determination of the individual iron need (the dosing of Ferinject according to its SPC was based on the simplified table exclusively); (2) calculation and administration of the iron dose(s); and (3) post-iron repletion assessments. Ferinject could be administered by three methods via the intravenous route: injection, infusion or during a haemodialysis session undiluted directly into the venous limb of the dialyser. When Ferinject was to be administered by intravenous injection an undiluted solution could be used and there were different administration rates based on the volume of Ferinject required and the equivalent iron dose. If using intravenous infusion Ferinject must be diluted according to a dilution plan as set out in the SPC which included a minimum administration time depending on the volume of Ferinject required and the equivalent iron dose and the amount of sterile 0.9% m/V sodium chloride used for dilution. The Panel noted that whilst the dosing of Ferinject within the context of IV iron therapy based on the simplified table might be simple compared to alternative IV irons which used the Ganzoni formula, it appeared that the administration of Ferinject was not simple as implied by the claim which the Panel considered was misleading and could not be substantiated. The Panel therefore ruled breaches of the Code.

The Panel then considered the complainant’s allegation that the claim ‘Simplified dosing and administration for all patients with Ferinject’ (Ferinject.co.uk/healthcare-professional (ref-UK-FCM-1900275, August 2019)) misleadingly implied that Ferinject could be used in patients under 14 years whereas the SPC stated that ‘The use of Ferinject has not been studied in children, and therefore is not recommended in children under 14 years’ and this was not included anywhere on the page.

The Panel noted that according to Vifor there were two ways that readers could access the ‘Administration’ page containing the claim in question, both via the health professional homepage. Firstly, via the ‘Administration’ tab at the top of the homepage and secondly, via a link for more information beneath the claims ‘SIMPLIFIED DOSING FOR ALL PATIENTS’ and ‘LICENSED FOR AGES 14 YEARS AND OVER’ which appeared within a section on the homepage headed ‘Why use Ferinject?’ along with four other claims for the product. All six claims were of equal prominence.

The Panel noted Vifor’s submission that the health professional homepage was accessed after selecting ‘I am a healthcare professional’ from the website landing page which clarified that the health professional section of the website was intended for health professionals ‘who treat iron deficiency and iron deficiency anaemia in adults…’ (emphasis added). The Panel further noted that if readers had accessed the Administration page via the ‘Why use Ferinject?’ section of the homepage they would have seen that Ferinject was only licensed for ages 14 and over. The Panel did not consider that the claim ‘Simplified dosing and administration for all patients with Ferinject’ implied that Ferinject could be used in patients under 14 years as alleged and no breaches of the Code were ruled.

The Code required that promotional material about prescription only medicines directed to a UK audience which is provided on the Internet must comply with all relevant requirements. The Panel noted its rulings of breaches of the Code in relation to material for health professionals and material for the public as set out above and therefore ruled breaches of the Code.

The Panel noted its comments and rulings above and considered that Vifor had failed to maintain high standards and a breach of the Code was ruled.

The Panel noted that the complainant had raised concerns about an employee not being a signatory and not understanding the principles of the Code. The Panel noted Vifor’s submission that the materials had been certified by its signatories and that the employee in question had played no role in the approval of the material at issue in this case. The Panel noted that the complainant bore the burden of proof and not provided evidence to establish his/her complaint in this regard on the balance of probabilities. The Panel therefore ruled no breach of Clause 9.1 in relation to this allegation.

The Panel noted that Clause 2 was a sign of particular censure and reserved for such use. The Panel did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2 and ruled no breach accordingly.