AUTH/2969/8/17 - Senior Practice Nurse v AstraZeneca

Conduct of a representative

  • Received
    03 August 2017
  • Case number
    AUTH/2969/8/17
  • Applicable Code year
    2016
  • Completed
    26 January 2018
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    May Review 2018

Case Summary

​A senior practice nurse complained about the conduct of a medical representative with AstraZeneca UK. The representative was promoting Forxiga (dapagliflozin) which was indicated to improve glycaemic control in adults aged 18 years or over with type 2 diabetes, either as monotherapy or as add-on combination therapy. 

The complainant stated that there had been several occasions when the representative had come into surgery asking to see him/her; all of which had been self-presentations at reception with no forwarding or booked appointment. When the representative was advised by the receptionists that the complainant was in surgery seeing patients he/ she became quite insistent that the complainant be contacted. The representative was advised to email the complainant directly. The complainant stated that on one occasion he/she had to go into reception in the middle of a minor surgery procedure with a GP to collect a consent form. The representative proceeded to try to talk to him/her in view and ear shot of other patients (after being told that the complainant was busy and needed in surgery) telling him/her that he/she should be changing all diabetic patients from canagliflozin (Invokana, marketed by Janssen) to Forxiga in view of recent surveys linking canagliflozin to increased lower limb amputation. 

The representative continued to follow the complainant down the corridor telling him/her how bad canagliflozin was. The complainant stated that he/she was happy to see representatives who wanted to advise him/her about their products but he/she found the AstraZeneca representative to be very unprofessional in his/her approach, basically slagging off her rival company. 

The complainant had since spoken to the canagliflozin representative to gain clarification on this matter and had decided to no longer see the AstraZeneca representative as his/her attitude was very threatening and unprofessional. 

The detailed response from AstraZeneca is given below. 

The Panel noted that according to the complainant his/her receptionist would confirm the representative's frequent visits and that he/ she could be quite persistent. The complainant also described the representative's behaviour as threatening and unprofessional. The Panel noted AstraZeneca's submission that the representative did not recall being told that the complainant was in minor surgery when he/she asked to see him/her and denied following the nurse down the corridor in an attempt to continue the conversation. The Panel noted that the complainant confirmed that the representative was fully aware that he/she was in minor surgery and did follow him/her down the corridor which he/she stated was witnessed by receptionists. According to the unsigned statement of the representative's line manager he/she had never witnessed the representative insist on seeing a health professional if told that he/she was busy. In relation to the allegation that the conversation at issue took place within earshot and in full view of patients the Panel noted that the parties' accounts differed. It was not possible to determine where the truth lay. The complainant bore the burden of proof and in this regard the Panel did not consider that the complainant had established a breach of the Code on this point as alleged. No breach of the Code was ruled. 

Similarly, in relation to the general allegation that the representative's behaviour was threatening and unprofessional the Panel considered that this had not been established by the complainant and no breach of the Code was ruled on this point. 

According to AstraZeneca the named doctor and complainant had given the representative verbal consent to call upon them whenever there were new updates in relation to Forxiga which was why the representative intended to discuss the amputation data with him/her and did not consider that he/ she had raised it proactively. The Panel noted that the complainant made no particular comment in this regard but had described the representative's visits as self-presentations at reception with no forwarding or booked appointment. AstraZeneca's HCP Interactions Guidance stated that a 'solicited contact may be recorded if during a prior interaction, the HCP or ORDM had 'given permission to call back at an agreed date and time or specific topic'. It was unclear whether the Guidance covered an open-ended consent to call-back which applied until such consent was withdrawn or otherwise terminated. The Panel made no judgement on the acceptability of open-ended call backs. The Panel was concerned that the guidance did not refer to recording such permission. The Panel was concerned that AstraZeneca was relying on unrecorded verbal consent and the representative's recollection of the same to apparently categorise subsequent calls as solicited. The impression given to health professionals by these arrangements was important bearing in mind the requirements of the Code including that such visits should not cause inconvenience and that the wishes of individuals must be observed. The Panel considered that as a matter of good governance such consent should be recorded internally and in writing to the health professional so that all parties were clear about what had been agreed verbally. It was of particular note that the complainant described the representative's visits as self-presentations and raised concerns about their frequency. 

The Panel noted that the HCP Interactions Guidance defined solicited contacts as set out above and stated that a solicited contact might be attendance at a group meeting including HCPs or ORDMs. The following page of the document describing AV/Rep Led meetings stated that these occurred normally with more than one HCP and appeared to suggest that group calls were all solicited by definition. The Panel noted that the representative had recorded meetings with the complainant and a named doctor as a group call on more than one occasion and on one occasion the doctor had not attended, however, it was still recorded as such. The Panel queried whether AstraZeneca's definition of a solicited call or group call or permission to call back satisfied the requirement of a solicited call as referred to in the Code. 

The Panel noted that the representative appeared to have called on the complainant four times between January and July. Two calls were described by AstraZeneca as group calls in an internal email dated 29 August summarising the calls at the named surgery, however, AstraZeneca confirmed that only the complainant was present at one of these calls and the second group call did not actually take place. The Panel further noted that the same summary described a meeting with the complainant on 17 January as a 1:1 call, however it appeared that the call report described the call type as group detail. It appeared that the representative called on the complainant three times at the named surgery within the six month period and all were recorded as 'solicited' calls. The Panel noted that the complainant's concerns were broader than calls and contacts and included attendances at reception. 

Notwithstanding all of the points outlined above and noting the complainant's burden of proof the Panel considered that there was insufficient evidence to establish on the balance of probabilities whether the number of unsolicited calls on the complainant exceeded 3 on average. The Panel therefore ruled no breach of the Code. Nonetheless, the Panel noted that serious concerns remained about the company's governance in this area, including the poor guidance to representatives about permission from a health professional to call back and unclear guidance about, and poor recording of calls and contacts as set out above. In this regard the Panel considered that the company had failed to maintain high standards. A breach of the Code was ruled. In addition, the Panel noted the poor governance shown by the representative with regards to call recording and the lack of detail therein meant that the representative had failed to maintain high standards and a breach of the Code was ruled. 

The Panel noted that there was no record of, or recollection from the representative in question of a discussion about the amputation data on 27 June; the call record was blank and did not detail discussion. The call of 27 June was logged implying that a dialogue had occurred which was in contrast to the representative's recollection. The Panel noted that when questioned how, in general, he/she might discuss the amputation data, the representative noted that he/she always clarified that all SGLT2is had a warning on the respective summary of product characteristics (SPCs) in relation to the risk of amputations and that canagliflozin had more clinical findings on the SPC but it was unknown whether this constituted a class effect. 

In relation to the conversation in question the Panel noted that according to the representative's statement during the interaction the complainant asked if there was anything new to discuss about Forxiga; the representative recalled that he/she said that he/she had some safety information on Forxiga and the SGLT2i class but that the word amputation was not used. The Panel noted AstraZeneca's submission that according to the representative canagliflozin was only referred to in order to inform the complainant that he/she should raise any questions about this medicine with the canagliflozin representative. The Panel noted that the complainant and his/her receptionist remembered the representative saying canagliflozin was dangerous and patients should be switched to dapagliflozin. 

The Panel considered that whilst it was likely that canagliflozin was discussed it was impossible to establish precisely what was said during the conversation and therefore it was not possible to determine on the balance of probabilities whether the representative had made misleading claims which were incapable of substantiation with regard to the amputation data for Forxiga or canagliflozin. No breaches of the Code were ruled. The Panel did not consider that evidence had been provided by the complainant to show whether on the balance of probabilities the representative had disparaged canagliflozin as alleged and no breach of the Code was ruled.

In relation to the briefing material the Panel noted that the sales force was first briefed about the increased risk of lower limb amputation with canagliflozin in July 2016 to enable the sales force to respond reactively to questions from health professionals about the emerging data in relation to canagliflozin and, inter alia, toe amputations. The sales force was specifically instructed that they must not prompt a health professional to ask a question about this. The Panel noted that the briefing stated that the information could be discussed in response to a direct HCP enquiry or proactively with a HCP known to have a safety concern in relation to the SGLT-2 inhibitor class. The briefing did state 'Do not prompt an HCP in conversation by saying, for example, 'Have you seen the news about the fractures with canagliflozin?'. 

An update was provided to the sales force on the amputation data for SGLT2is in a presentation dated March 2017 which informed the sales force of the likely changes to the SPCs for all SGLT2is. The presentation detailed further studies including CANVAS-R wherein the incidence of lower limb amputations for canagliflozin v placebo was not statistically significant. It further stated that a higher incidence of amputation was not observed across 12 other completed Phase 3/4 clinical trials'. It reproduced expected label updates for Forxiga and canagliflozin. 

An email in June 2017 advised the sales force that the CANVAS results must not be proactively discussed with customers. An objection handler was issued in July 2017 which was only to be used reactively in response to questions relating to the risk of lower limb amputation for Forxiga vs canagliflozin. According to AstraZeneca the information included was based on the factual wording in the medicines' SPCs. The Panel noted that both the objection handler and the March 2017 presentation stated that 'to date there had been no increased risk seen in the clinical trial programme for Forxiga' and 'To date we are not aware of any imbalance in lower limb amputations in the Forxiga clinical trial program'. The Panel further noted the representative's line manager's interview statement that it was now known that it was not a class effect. The Panel queried whether this was entirely consistent with the Forxiga SPC which stated that it was unclear whether there was a class effect. 

The Panel noted the line manager's statement that there was no instruction to lead on a discussion of the SPC changes. AstraZeneca clarified that in the line manager's previous statement 'Where there is high cana use I am comfortable that my team discuss the side effect profile proactively with HCPs, including the amputation data' he/she was referring to the amputation data in the Forxiga detail aid which was in relation to Forxiga only and made no reference to canagliflozin. The Panel considered that this was in contrast to AstraZeneca's submission that the representative confirmed that he/she intended to discuss the changes to the Forxiga SPC and the SGLT2i class, and would have expected canagliflozin to have been discussed in that context, albeit the representative did not think that it was being raised proactively as he/she had verbal permission to call on the complainant with any new Forxiga data. It was also inconsistent with AstraZeneca's submission that in response to questioning the representative's line manager stated that the representative when discussing the amputation data noted that there was data to indicate an increased risk with canagliflozin but that it was unknown whether this was a class effect for all SGLT2is. 

The Panel noted its general concerns about the briefing material as outlined above but did not consider that there was evidence to show that on the balance of probabilities AstraZeneca had provided briefing that advocated, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code. No breach of the Code was ruled. 

The Panel noted its concerns and rulings above but did not consider that a ruling of a breach of Clause 2 was warranted and no breach of Clause 2 was ruled