AUTH/2920/12/16 - Anonymous, non-contactable ex-employee v UCB

Promotion of Naloxone Minijet

  • Received
    20 December 2016
  • Case number
    AUTH/2920/12/16
  • Applicable Code year
    2016
  • Completed
    27 March 2017
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    May 2017 Review

Case Summary

An anonymous, non-contactable ex-representative of UCB Pharma alleged that he/she was asked to promote Naloxone Minijet Injection off licence.

The complainant explained that naloxone was a generic product and many other companies marketed it.  UCB’s naloxone had a narrow indication mainly for the treatment of respiratory depression induced by natural and synthetic opioids. The complainant submitted, however, that naloxone marketed by Martindale had a broader indication in that it was licensed for complete and partial reversal of opioid depression and not only the respiratory depression associated with it.

The complainant submitted that in 2012 the Advisory Council on the Misuse of Drugs recommended that take-home naloxone should be made more widely available.  Public Health England also produced guidance on promoting the wider availability of naloxone to reduce overdose deaths from heroin and the like.

Under this guidance, naloxone could be supplied to anyone who: currently used illicit opiates such as heroin; received opioid substitution therapy; left prison with a history of drug use or previously used opiates (to protect in the event of relapse).  Under this guidance, with the agreement of someone to whom naloxone could be supplied, it could also be provided to their family members, carers, peers and friends.  Other UK nations also came up with similar guidelines.

The complainant stated that UCB representatives were asked to promote take-home naloxone Minijets to prescribers, pharmacists and budget holders.  Representatives were told by their line manager that by doing this the sales of UCB’s product would increase which would easily help to achieve targets. The complainant also referred to a poster which was produced for a company sales meeting by one of his/ her colleagues in the Minijets team. 

The complainant was concerned that although government agencies published clear guidelines on naloxone take-home, UCB’s naloxone was not licensed for this indication but representatives were asked to actively promote it in this indication for financial gains.  The company asked representatives to pursue a course of action which was in breach of the Code.  The complainant alleged that the company and senior managers did not maintain high standards because the poster was presented and commended at a national sales conference and no one picked it up.  There were also patient safety issues in keeping and properly administering an injectable as the complainant did not remember any training support for the same.  The complainant alleged that UCB acted in a highly unprofessional way and that this activity was known to many senior managers and had happened for a long time; if unchecked these types of activities could bring discredit to the whole industry.

The complainant noted that UCB had recently sold the entire Minijets product portfolio to a third party but in his/her view a company could be reprimanded for its historical wrong doings.

The detailed response from UCB is given below.

The Panel noted that the complainant was anonymous and non-contactable.  The Constitution and Procedure stated that anonymous complaints would be accepted, but that like all other complaints, 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 could not be contacted for more information.  The Panel noted the parties’ interpretation of the licensed indication for naloxone Minijet differed. 

The Panel noted that naloxone Minijet 400mcg/ ml was indicated for the treatment of respiratory depression induced by natural or synthetic opioids.  The medicine was presented as prefilled syringes of 1 or 2mls (400 or 800mcg).  The usual initial adult dose was 400 - 2000mcg every 2 to 3 minutes if necessary.  If no response was observed after the administration of 10mg then the depressive condition might be caused by a medicine or a disease process not responsive to naloxone.  Treatment of overdose might thus require the use of a number of Minijet syringes.  Use of naloxone Minijet in the nonmedical setting was not referred to in the SPC and in that regard it did not appear that the product was specifically intended or packaged for such use and so non-medical responders might find it more difficult to use than other forms of naloxone, particularly Martindale’s Prenoxad.  Nonetheless, the Panel did not consider that take-home use of naloxone Minijet was off licence per se as alleged.  No breach of the Code was ruled.

The Panel disagreed with UCB’s submission that the poster was not briefing material for the representatives; it had been presented at an internal UCB conference with the purpose of sharing best practice.  The Panel assumed that as the poster had been developed by a representative, it mirrored what he/she considered was acceptable to claim about naloxone Minijet.  The Panel noted that the poster did refer to training family friends, however it was extremely concerned that the title of the poster stated, without qualification, ‘Minijet team Naloxone: How a Take Away Can Save Hundreds of Lives’.  There was no reference cited in support of the statement and no indication as to the time period over which hundreds of lives would be saved by naloxone Minijet.  Additional text stated that an overdose could now be referred to in the present tense: ‘I have a friend who [overdosed] last week. Naloxone did that’ which implied that naloxone saved the lives of everyone who overdosed.  The poster also stated that naloxone Minijet provided the ideal offering, and in that regard the Panel noted its comments above about Prenoxad.  The poster also stated that naloxone Minijet had the potential to dominate the market and that the dose of the competitor was too high.  The Panel considered that the content of the poster was such that it advocated claims for take-home naloxone Minijet, or the competitor, which were likely to be in breach of the Code.  A breach of the Code was ruled.  Overall the Panel considered that, given its content, the production of the poster showed poor judgement and in that regard it ruled a breach of the Code as it considered that high standards had not been maintained.

The Panel noted its rulings and comments above and although it had some concerns, it did not consider that the circumstances were such as to rule a breach of Clause 2 which was seen as a sign of particular censure and reserved for such.  No breach of Clause 2 was ruled.