AUTH/3056/8/18 - Ex-representative vs GlaxoSmithKline

Conduct of GlaxoSmithKline

  • Received
    31 July 2018
  • Case number
  • Applicable Code year
  • Completed
    12 March 2019
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2019 Review

Case Summary

An ex-representative of GlaxoSmithKline complained about GlaxoSmithKline’s relationship with a named practice-based pharmacist and secondly about a claim in the digital sales aids for Relvar Ellipta (fluticasone furoate, vilanterol trifenatate), Anoro Ellipta (vilanterol trifenatate, umeclidinium bromide) and Trelegy Ellipta (fluticasone furoate, vilanterol trifenatate, umeclidinium bromide).

The detailed response from GlaxoSmithKline is given below.

1 GlaxoSmithKline’s relationship with a practice based pharmacist

The complainant alleged that a named pharmacist conducted a therapeutic review from a competitor product to Relvar and Incruse (umeclidinium bromide) without any initial input from GlaxoSmithKline.  Having realised this, GlaxoSmithKline decided to use this to its advantage and initially had a ‘Q and A’ [question and answer] session at a national conference to show the success of what had been done.

The complainant stated that he/she attended a regional meeting along with representatives where the pharmacist in question did another ‘Q and A’ session and presented documents (copies provided).  The complainant alleged that the objective was that representatives would ask health professionals if they needed support in carrying out a switch to a GlaxoSmithKline product.  If the health professional replied yes, then the representative would email their contact details to a named senior representative who would contact the pharmacist in question who would then send over the documents to the health professionals.  The senior representative in question kept a tracker of health professionals who had been contacted and submitted this higher up and had possibly received a higher rating of performance based on this piece of work.  In the complainant’s view this was supporting a switch/review to GlaxoSmithKline products.

The complainant stated that whilst there was no direct proof he/she queried if the pharmacist in question would have created a ‘how to’ document if he/she had not been contacted by GlaxoSmithKline.  The complainant queried whether payments made to this pharmacist were in line with the time he/she spent for sharing his/her experience. 

The Panel noted GlaxoSmithKline’s submission that the pharmacist in question was contracted to speak at three internal meetings; the national sales conference in March 2017, a regional meeting in December 2017 and a respiratory leadership meeting in March 2018.  The Panel noted the hourly rate and the number of hours the pharmacist was paid for.  On the basis of the information before it, the Panel considered that there was no evidence to support the complainant’s allegation that payments to this pharmacist for these meetings were not in line with the time spent for speaking at meetings and no breach was ruled.

The Panel noted that the documents provided by the complainant included a protocol for inhaler changes for patients with COPD.  The protocol referred to the practice pharmacist identifying all listed COPD patients on Seretide Accuhaler 500/50mcg and Spriva Capsules 18mcg and excluding from the switch those patients who were unwell or unstable as identified from their records.  All the other patients would have their Seretide accuhaler changed to Relvar Ellipta 92/22 and their Spiriva inhalation capsules changed to Incruse Ellipta.  The Panel considered, as acknowledged by GlaxoSmithKline, that the reference to GlaxoSmithKline in the protocol gave the impression that GlaxoSmithKline was somehow involved in the protocol and the service. 

The Panel noted GlaxoSmithKline’s submission that following the national conference in March 2017, the pharmacist in question offered to be contacted by interested health professionals to share his/her positive experience of medicine optimisation.  The Panel noted GlaxoSmithKline’s submission that it did not pay this pharmacist to speak to other practice-based pharmacists on its behalf nor did it make any payments in respect of any aspect of his/ her medicines optimisation activity. 

The Panel noted that in August 2017 the pharmacist in question emailed the senior representative in question informing him/her that he/she had sent information to a named individual from a named area regarding inhaler switches.  The email included the information sent as attachments, which were saved as ‘GSK protocol for inhaler changes in COPD’, ‘GSK Seretide letter’, ‘GSK COPD letter, Seretide and Spiriva’, and ‘GSK Spiriva letter’ and appeared to be the same documents as those provided by the complainant.  The Panel noted that whilst it had concerns with regard to the misleading impression created by the attached documents and the lack of follow up by the representative to clarify the position,  it did not consider that there was evidence to suggest that GlaxoSmithKline had initiated, contributed to or funded the documents in question as implied by the allegation that the ‘how to’ document would not exist had GlaxoSmithKline not contacted the pharmacist in question.  No breach was ruled in this regard. 

The Panel was concerned to note that GlaxoSmithKline knew about the content of the documents and that the pharmacist in question was providing these to practices following ‘referrals’ from GlaxoSmithKline representatives, yet it took no action other than to decline to pay for the documents.  The Panel further noted GlaxoSmithKline’s submission that the pharmacist in question was asked by some representatives to share copies of his/her documents with other practices.  GlaxoSmithKline acknowledged that it was not appropriate for the company to endorse or encourage the activity and the representatives in question should have taken the opportunity to reinforce GlaxoSmithKline’s position on switch and to clarify the nature of GlaxoSmithKline’s involvement with the pharmacist in question.  The Panel considered that high standards had not been maintained in this regard, as acknowledged by the company, and a breach was ruled. 

The Panel noted that although the pharmacist in question was not being paid to speak to interested peers, GlaxoSmithKline representatives were actively involved in the introduction of practices to him/her.  The Panel noted that communication between the GlaxoSmithKline representatives and practices, for which GlaxoSmithKline was responsible, and communication between the pharmacist in question and the practices for which GlaxoSmithKline was potentially responsible for, might lead to a change to GlaxoSmithKline’s medicines.  The Panel noted that the Code did not prohibit a company from promoting a switch but did prohibit switch services paid for or facilitated directly or indirectly by a pharmaceutical company whereby a patient’s medicine was simply changed to another.

The Panel noted that it could be argued that the provision of documents to practices, including template letters, via referrals from GlaxoSmithKline’s representatives, went beyond promoting a switch.  There was a fine line between simply promoting a switch and providing so much detailed information in that regard that the information facilitated a switch.

The Panel considered that there was insufficient evidence as to whether any change of medicine was as a result of a switch service or a therapy review or that the pharmacist in question or GlaxoSmithKline had actually assisted any health professional in implementing a change to a GlaxoSmithKline medicine.  GlaxoSmithKline had made no payment in relation to any service.  Taking all the circumstances into account the Panel decided that on balance there was insufficient evidence to show that overall GlaxoSmithKline arrangements facilitated a switch to its medicines as prohibited by the Code.  The Panel ruled no breaches of the Code accordingly. 

The Panel noted that the conversations between the representatives including the completion of the senior representative’s tracker, together with the presentations by the pharmacist at both the national and regional meetings, would add to the impression that GlaxoSmithKline supported and endorsed the pharmacist’s views and approaches and might be seen by representatives as instructions on how the product should be promoted.  The Panel considered that the documents provided by the pharmacist in question to the 12 representatives at the regional meeting in December 2017, which could be seen as setting out GlaxoSmithKline’s involvement in a switch service, in effect constituted briefing material.  The Panel noted that GlaxoSmithKline made no submission with regard to any follow up with the 12 representatives confirming that it did not endorse this pharmacist’s protocol or to remind the representatives of the company’s position on switching.  Whilst the Panel was concerned at the lack of clear guidance provided by the company, it did not consider, on the balance of probabilities, that the communications above advocated a course of action likely to be in breach of the Code and no breach was ruled.

The Panel noted that whilst GlaxoSmithKline had fallen short of the expected standards of documentation required by the Code in this instance as acknowledged by the company, the complainant had not established that this meant that there was a widespread lack of written communication and projects would disproportionately rely on verbal communication as alleged.  The Panel considered that there was no evidence before it that the frequency of meetings between the pharmacist in question and GlaxoSmithKline representatives, prior to him speaking at national and regional meetings, were indicative of inappropriate verbal briefings for the meetings and no breach was ruled in this regard.

Although the Panel had some concerns about the overall arrangements and oversight by GlaxoSmithKline it did not consider that, on balance, the circumstances warranted a ruling of a breach of Clause 2, which was a sign of particular censure and reserved for such use, and ruled no breach accordingly.

2 Claim in digital sales aids for Relvar Ellipta, Anoro Ellipta and Trelegy Ellipta

The complainant stated that the digital sales aid for Relvar Ellipta, Anoro Ellipta and Trelegy Ellipta had a page that described the device as ‘open, inhale and close.’  This key message was contrary to the information provided in both the summary of product characteristics (SPC) and the patient information leaflet (PIL) which required more steps for the patient to benefit from the medication.

The Panel noted GlaxoSmithKline’s submission that no Trelegy digital sales aids included any reference to open, inhale and close.  The complainant had not provided any evidence to the contrary.  The Panel, therefore, based on the very narrow allegation, ruled no breach with regard to the Trelegy sales aids.

The Panel noted that the Relvar Ellipta SPC stated under the method of administration that the step-by-step instructions should be followed.  According to the Relvar SPC there were four steps.

The Panel accepted that as far as the device was concerned, it had to be opened by the patient, used for inhalation and closed by the patient.  However, to take the medicine correctly and, inter alia, for the dose to be effective the patient had to do more than simply open, inhale and close.  The required steps were detailed in the Relvar and Incruse SPCs and PILs.  It appeared from the material provided that, despite reading the PIL, some patients still made a critical error which was defined as an error most likely to result in no, or minimal, medication being inhaled. 

In the Panel’s view, the references to ‘…efficacy in 3 steps: patients simply Open Inhale Close’ in the Relvar/Incruse digital sales aids (January 2018, May 2016, April 2017) and the Relvar asthma digital sales aids (May 2016, May 2017) were misleading and inconsistent with the Relvar SPC.  Breaches of the Code were ruled. 

On balance, the Panel considered that the Relvar Asthma digital sales aids (September 2017 and October 2017) which referred to ‘With just 3 steps: patients simply Open Inhale Close’ and the implication that it related to patient benefit from the medicine with just 3 steps, was misleading and inconsistent with the Relvar SPC and breaches of the Code were ruled.

The Panel noted that the current Relvar Ellipta digital sales aid (March 2018 ref UK/FFT/0004/18) did not refer to either ‘…efficacy in 3 steps: patients simply Open Inhale Close’ or ‘With just 3 steps: patients simply Open Inhale Close’ as featured in previous Relvar digital sales aids.  The current sales aid contained interactive Ellipta pages which referred to the mechanisms of the device rather than instructions on how patients should use the device; there were no claims regarding the number of steps required by the patient to benefit from the medicine and each page of the Interactive Ellipta section referred the user to the PIL for patient instructions.  In the Panel’s view, there was no evidence that the reference to open inhale close in the context of the Interactive Ellipta section was misleading or inconsistent with the SPC as alleged and no breaches were ruled.

Although there was no current digital sales aid for Anoro, previous versions (November 2016 and January 2017), used during the time-period in scope of the complaint, referred to open (with a ‘click’), inhale and close beneath the statement ‘delivered in a once-daily, easy-to-use Ellipta inhaler’.  The Panel noted that the Anoro SPC and PIL referred to three steps when taking the medicine: first ‘Prepare a dose’ (including sliding the cover down until a click was heard); second ‘How to inhale the medicinal product’; and third ‘Close the inhaler’.  Full details for how the patient was to perform each step were in the SPC and PIL.  In the Panel’s view, the page in question referred to the delivery of the medicine and there were no claims linking efficacy or patient benefit from the medicine to the 3 steps open, inhale and close.  The Panel considered that in the circumstances and based on the narrow allegation the page in question was not misleading or inconsistent with the SPC and no breaches were ruled accordingly.

Noting its comments and rulings above, the Panel did not consider that GlaxoSmithKline had failed to maintain high standards and ruled no breach accordingly.