AUTH/2796/9/15 - Health Professional v Bausch & Lomb

Pulse Quick Guide

  • Received
    24 September 2015
  • Case number
    AUTH/2796/9/15
  • Applicable Code year
    2015
  • Completed
    11 December 2015
  • No breach Clause(s)
    7.2, 7.4 and 7.11
  • Breach Clause(s)
    2, 7.2, 7.4, 7.10, 9.1 and 12.1
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    February 2016

Case Summary

​A general practitioner (GP) who was a GP trainer with an interest in allergy complained about an article published in Pulse as a Pulse Quick Guide. The article was entitled 'New approaches in management and treatment of anaphylaxis' and discussed adrenaline auto injectors (AAI) in relation to administration needle length, skin to muscle depth, and dosage cost. The named author was a consultant allergist who had been commissioned to write the article. An advertisement for Emerade (adrenaline) marketed by Bausch & Lomb appeared on the reverse. 

Emerade was indicated for the emergency treatment of severe acute allergic reactions (anaphylaxis) triggered by allergens in foods, medicines, insect stings or bites, and other allergens as well as for exercise-induced or idiopathic anaphylaxis. 

The complainant noted that the item was presented as a Pulse article on anaphylaxis; whereas it was obviously promotional. The complainant was unaware that any 'New guidelines' were presented. The Emerade device had been in the UK for over 2 years. Many of the suggestions appeared to be unscientific and poorly referenced, with very broad assumptions presented as fact. 

The complainant queried the claim '68% of the allergy population has a STMD [skin-to-muscle depth] greater than the most common AAI [adrenaline autoinjectors]' and if this was really so including children. Just giving the STMD did not allow for the compression of fat/skin when a needle was pressed into the thigh. He/she understood that the European Medicines Agency (EMA) recently (June 2015) gave a Committee for Medicinal Products for Human Use report on AAIs. It suggested that further data should be generated but that until then, proper educational material should be given to patients and carers.

The statement that the British National Formulary (BNF) recommended a 500mcg dose was not correct, unless the new anticipated BNF had changed this recommendation.

The dosage suggestions of the UK Resuscitation Council were for professionals, not for patients' self administration. The complainant also queried what 'for some patients' actually meant in the bullet point 'For some patients, The UK Resuscitation Council also recommends 500mcg of adrenaline and makes specific needle length recommendations for intramuscular delivery'. The complainant alleged that it was unclear and misleading. 'Some patients' might equally be overdosing on the 500mcg dose. The complainant found it hard to believe this was an error in the article and believed it was included as a deliberate attempt to confuse doctors. 

The referenced article on accuracy in use of AAIs was written in part by a non-clinical psychologist and was funded in part by the UK distributor of Emerade. 100% success with their sponsor's device, was astonishing, at the very least. 

The cost per annum savings were made on the assumption that the AAIs were not used at all. The complainant understood that the published shelf lives were not relevant to the actual surviving shelf life when the devices were actually dispensed. 

The detailed response from Bausch & Lomb is given below. 

The Panel noted that the Pulse Quick Guide was supplied with Pulse as an A4 laminated loose insert, a full page Emerade advertisement appeared on the reverse. The comparison of shelf life at production, cost to the NHS and cost per annum were included in a table comparing Emerade, EpiPen and Jext. The table also included doses and exposed needle length. 

The Panel noted the origin of the Pulse Guide and Bausch & Lomb's submission that the Pulse Quick Guide was clearly identified as being 'Initiated, developed, and funded by Bausch & Lomb' as stated in the top right hand corner of the article. The Panel noted that it appeared adjacent to the heading 'Pulse Quick Guide'. However, it was in a very small font size compared to the heading and subheading, in a black type face and was not emboldened. In the Panel's view, this would be missed by many readers. The Panel did not consider that the statement was prominent enough to ensure awareness of the company's role at the outset. The Panel also noted that 'see reverse for prescribing information' appeared at the bottom of the article in black, unemboldened font and appeared, at first glance, to be part of the article itself. The Panel considered that the nature of the material and role of the company was not clear. This misleading impression was compounded by the prominence of the Pulse and Nursing in Practice logos. Some readers might assume that the article was independent editorial matter. The material was disguised in that regard and a breach of the Code was ruled. 

The Panel noted that the Quick Guide referred to new approaches rather than new guidelines as alleged by the complainant. Whilst the Panel noted that Emerade was first authorized in January 2013 it queried whether there were in fact new approaches in the management of treatment of anaphylaxis considering the length of time Emerade had been available. However, the allegations related to 'new guidelines' and as neither this phrase nor a closely similar phrase had been used or implied, the Panel ruled no breach of the Code on this narrow ground. 

With regard to the claim '… 68% of the allergy population having a STMD greater than the most common AAI …' the Panel noted that Johnstone et al reported STMDs >15mm in 68% of adults. The two other references quoted lower percentages in children, namely 60% and 30%. The Panel considered that the claim implied that 68% of the entire allergy population had an STMD greater than that of the most common AAIs. This was not so. The Panel considered that the statement was misleading and could not be substantiated. Breaches of the Code were ruled.

In the Panel's view the reference to the BNF dose in the Guide was misleading. The Guide did not refer to severe anaphylaxis as mentioned in the BNF and neither the Guide nor the BNF reflected the dose recommended in the summary of product characteristics (SPC). A breach of the Code was ruled. 

The Panel considered that it would be helpful if the Guide was clear that the UK Resuscitation Council guidelines were for health professionals considering that elsewhere the Guide was concerned with self administration. However, it did not consider that in the circumstances it was misleading and on this narrow ground ruled no breach of the Code. In the Panel's view, the Guide should be clearer about both the licensed dose of Emerade and the patients for whom 500mcg adrenaline was recommended. The SPC stated that 500mcg was not recommended for use in children. The UK Resuscitation Council guidelines recommended 500mcg for patients aged 12 and over except for those that were small or prepubertal. The Panel considered that the Guide was not sufficiently clear regarding the licensed doses. There was a possibility that it might lead to some patients being inappropriately prescribed a dose of 500mcg. This was clearly contraindicated in children. The Panel considered that the Guide was misleading and did not promote the rational use of the medicine. Breaches of the Code were ruled. Such material could potentially have an impact on patient safety. The Panel ruled a breach of the Code as high standards had not been maintained. The Panel noted that prejudicing patient safety was an activity likely to be ruled in breach of Clause 2. The Panel noted that there was no evidence to show that patient safety had been adversely affected but considered that to provide misleading information about licensed doses was a serious matter particularly given that the 500mcg dose was contraindicated in children and on balance a breach of Clause 2 was ruled. 

With regard to the allegation about cost per annum savings, the Panel noted Bausch & Lomb's submission that as the bulk of all AAI's in circulation were never used, a longer shelf life was a beneficial factor as the requirement to replace the pen would be less frequent. The Panel noted that Emerade had a shelf life at production of 30 months compared to EpiPen and Jext with 18 months each. The Panel examined the table comparing the products. The costs were given and the final column gave the cost per annum; the cheapest being Emerade at £10.78 (150 and 300mcg). The column detailing shelf-life was headed 'Shelf life at production (months)'. In addition the bullet point in the conclusion read 'Emerade reduces cost, with the longest shelf life at production (30 months) compared to Jext /EpiPen (18 months). The Panel considered that it was clear that the longer shelf life referred to the maximum shelf life from the date of production. Whilst the supply chain was relevant the Panel considered that the Guide was sufficiently clear that it was referring to the shelf life at production. The Panel did not consider that readers would be misled in this regard and ruled no breach of the Code. The Panel considered that neither the table nor the bullet point 'Emerade reduces cost with the longest shelf-life at production …' were incapable of substantiation on this point and no breach of the Code was ruled.​