AUTH/3436/12/20 - Voluntary admission by Janssen

Nurse led Stelara homecare service

  • Received
    01 December 2020
  • Case number
    AUTH/3436/12/20
  • Applicable Code year
    2019
  • Completed
    Interim case report
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Advertisement
    Audit of company’s procedures
    Public reprimand
  • Appeal
    No appeal

Case Summary

INTERIM CASE REPORT

An interim case report has been published in this case as the final report was delayed because the Code of Practice Appeal Board had required audits of Janssen’s procedures in relation to the Code (Paragraph 11.2 of the Constitution and Procedure refers).

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Janssen-Cilag voluntarily admitted that it had failed to maintain oversight and high standards in relation to the delivery of a service described by Janssen as a Stelara (ustekinumab) patient support programme delivered by a third-party homecare provider. Stelara was used in the treatment of certain adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Janssen.

Janssen stated that the issues related to a failure to appropriately terminate the service with the vendor in 2018, when Janssen believed the service had been cancelled when, in fact, it had continued, and the subsequent lack of ongoing oversight of the programme. In summary Janssen failed to:

• Provide adequate adverse event reporting training with the vendor
• Maintain up-to-date product training with the vendor including provision of updates to the summary of product characteristics (SPC)
• Robustly review and store all related materials and documents
• Correctly characterise the adverse events reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as being solicited

Janssen acknowledged that that was not consistent with the high standards to which it held itself and was in breach of the Code. Janssen understood that the Panel might consider that it was also a breach of Clause 2.

The Panel noted that Janssen described the home delivery and nurse administration service as a patient support programme. The Panel noted that the service did not satisfy the requirements of a formal patient support programme as set out in the Code and its supplementary information. The Panel noted that the classification of the service was not the subject of the voluntary admission and thus was not ruled upon. The Panel noted that in general terms such homecare services might be offered as part of a package deal.
The Panel noted Janssen’s submission that it commissioned a Stelara homecare service with a service provider in 2010 which was initially for a NHS trust and subsequently expanded to three trusts. The service was to allow patients to have their medication delivered to their homes and to provide either home-based self-administration training or ongoing home nurse-administration support.

The Panel noted Janssen’s submission that there was a lack of ongoing oversight of the service between January 2018 and May 2020. As a result of this, Janssen had failed to: provide adequate adverse event reporting training with the vendor; maintain up-to-date product training with the vendor including provision of updates to the summary of product characteristics (SPC); robustly review and store all related materials and documents and correctly characterise the adverse events reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as being solicited.

The Panel noted that during the time-period in question there were two applicable codes: the 2016 and the 2019 Code. The clauses at issue were similar in both versions of the Code so the Panel made its rulings in relation to the 2019 Code.

The Panel noted Janssen’s submission that the activity had not been recorded as active since 2018, which resulted in the incorrect reporting of adverse events to the MHRA. The Panel noted Janssen’s submission that the service provider continued to report adverse events to Janssen which in turn reported the adverse events to the MHRA as being unsolicited, when in fact they should have been reported as solicited as they were associated with the Stelara homecare service. This was corrected for eleven cases in the safety database in June 2020 as part of Janssen’s remediation and corrective actions.

The Panel was extremely concerned with regard to Janssen’s submission that documentation relating to the service in question was ‘incomplete’ and that it was not able to identify agreements prior to Quarter 1, 2018 that described the service. Furthermore, since January 2018, there had not been any documentation in place. The service provider was only able to provide Janssen with the master services agreement (dated July 2015) which did not specifically refer to the Stelara homecare service.

The Panel noted Janssen’s submission that the decision to terminate the agreement in 2018 was in the incorrect belief that there were no patients ongoing in the programme and that the service no longer delivered value for patients or the NHS. Further that the decision to terminate the agreement was communicated in a series of emails between Janssen and the vendor between January 2018 and May 2018 and on the company’s review of this email exchange it was evident that the instructions were not clear nor fully understood.

The Panel noted Janssen’s submission that in May 2020 the service was being provided to 24 patients and given the COVID pandemic, the company deemed it inappropriate to terminate the service immediately. The service would continue to be provided until 11 March 2021.

The Panel noted that Janssen stated that it became aware of the issue on 29 May 2020 and ‘immediate’ remediation and corrective actions had taken place between 5 June and 28 August 2020. The Panel further noted Janssen’s submission that given the complexity of the issue, the extent of the investigation conducted, the escalation to the highest levels of the global organisation and the prioritisation of corrective and preventive actions, it was not until December 2020 that the company considered that it had the required information to make a voluntary admission to the PMCPA. The Panel queried whether the length of time between identification of the issue which had patient safety implications, in May 2020, and the voluntary admission to the PMCPA, in December 2020, was acceptable.

The Panel had no information before it in relation to the individuals in Janssen or the service provider who were concerned with the preparation or approval of material or activities related to the Stelara homecare service. Whilst the Panel was extremely concerned that individuals in Janssen responsible for the Stelara homecare service did not appropriately terminate the service, and that communication within Janssen and between Janssen and the homecare service provider was extremely poor, the Panel had no evidence before it that relevant staff were not fully conversant with the Code and the relevant laws and regulations and no breach of the Code was ruled in that regard.

The Panel noted that as part of its admission, Janssen had referred to the training of its field based staff. In the Panel’s view, however, Janssen had not made any admission in relation toits representatives not taking an appropriate examination and it ruled no breach of the Code.

The Panel noted Janssen’s submission that since 2018, the service provider had not been notified of any SPC updates, there was a lack of documented evidence that the service provider had completed Janssen pharmacovigilance training, and the company had failed to provide product training to the service provider beyond initial set-up training prior to 2018. It was not clear to the Panel what changes to the Stelara SPC had occurred during this time; Janssen made no submission in that regard. The Panel was extremely concerned that for over two years, Janssen had no oversight or management of this Stelara homecare service and that the nurses providing the support had received no training, product or safety updates during that time. The Panel considered that Janssen had failed to maintain high standards and thus ruled a breach of the Code as acknowledged by Janssen.

In the Panel’s view, this was an extremely serious matter that had patient safety implications. In the Panel’s view, Janssen’s lack of oversight and management of the Stelara homecare service, including its failures to provide product and pharmacovigilance training to the nursing team and to notify them of SPC updates for more than two years had brought discredit upon and reduced confidence in the industry; the Panel ruled a breach of Clause 2 of the Code.

The Panel was extremely concerned about its rulings and comments above. The Panel considered that it was crucial that patients, healthcare organisations and others could rely on companies funding homecare services to ensure that the arrangements complied with the Code and were such that patient safety was paramount. The Panel noted that Janssen had taken some steps to address the matters raised and that these had been brought to the attention of the global company. Nonetheless, the nature of the difficulties revealed by the voluntary admission was extremely concerning. The Panel considered it was inexplicable that the Stelara homecare service continued without the company’s apparent knowledge from January 2018 until May 2020, given it appeared that monies continued to be paid to the service provider and adverse events processed (albeit incorrectly characterised). The company’s procedures and approach to compliance should have prevented this. The Panel was concerned that neither Janssen nor its service provider were able to locate the relevant contract and thus it was unclear to what standards the service provider operated in relation to the service. This was compounded by the fact that had the relevant SOP which came in to force 25 March 2019 been followed, it might have prevented certain difficulties (governance of contract, training and the requirement for a detailed handover to a new project owner), although its definition of a patient support programme did not appear to be relevant to the Stelara homecare service. Some of the matters raised went to the heart of self-regulation and patient safety. The company’s lack of oversight and management of the homecare service at issue had been extremely poor. The Panel decided, in accordance with Paragraph 8.2 of the Constitution and Procedure, to report the company to the Appeal Board for it to consider whether further sanctions were appropriate in this case.

The Appeal Board noted the Panel’s comments and rulings of breaches of the Code and that Janssen had provided details about its plan to address the issues and it had apologised.

However, the Appeal Board was deeply concerned about the failings and Janssen’s lack of control, checks and oversight that had allowed the patient facing Stelara homecare service to continue without the company’s knowledge from January 2018 until May 2020, and that monies had continued to be paid to the service provider. The Appeal Board noted that adverse event reports had been processed by the service provider and reported (albeit incorrectly characterised) by Janssen. The Appeal Board noted Janssen’s failure to provide product and pharmacovigilance training to the nursing team and updates on changes to the Stelara SPC. In response to a question, Janssen stated that there had been a number of changes to the SPC during the relevant period including the provision of extra clarity around hypersensitivity reactions and very few changes were material to patient safety; there were no important safety updates which led to an increased risk to patients. Further, the third-party service provider trained its staff to use the electronic medicines compendium (eMC) website for the SPC, which would have been up-to-date; there had been no specific training by Janssen in respect of the meaning of such changes. The adverse events were reported as unsolicited and Janssen submitted that these were given a higher priority than solicited reports. The company had introduced more mechanisms to ensure that pharmacovigilance staff were more aware of ongoing relevant programmes. There were a number of third-party service providers delivering the homecare service which had now been the subject of audit as a result of which one had been terminated.

When questioned by the Appeal Board about the delay in making the voluntary admission, Janssen referred to the decision to understand the root cause of the issue and to make remediations. The COVID-19 pandemic and lockdown and the impact that had on interactions with third party providers and major gaps in staffing had contributed to the delay. The Appeal Board considered that the period from discovery to reporting to the PMCPA was inexplicably long at over 7 months and it noted Janssen’s acknowledgment in this regard. The Appeal Board noted Janssen’s submission that it had made improvements and changes to ensure that this issue did not recur.

The Appeal Board decided that in accordance with Paragraph 11.3 of the Constitution and Procedure, Janssen should be publicly reprimanded for its failure to have oversight or control of a patient-facing service for 28 months and for its delay in making its voluntary admission once the errors had come to the company’s attention. The Appeal Board also decided to require an audit of Janssen’s procedures in relation to the Code. The audit should take place as soon as possible. On receipt of the report of the audit the Appeal Board would consider whether further sanctions were necessary.

On receipt of the November 2021 report of the audit the Appeal Board was very concerned about the findings noting the depth and scale of the difficulties at Janssen. The Appeal Board was particularly concerned about the patient support programmes, noting that such compliance issues were not limited to the patient support programme in question in Case AUTH/3436/12/20. In the Appeal Board’s view the failure to have appropriate oversight of the patient support programmes including the failure to train nurses on certain SPC updates was serious. Public and patient confidence in the arrangements for such programmes was paramount.

The Appeal Board noted that the audit raised broad concerns about compliance and it highlighted many concerns that needed to be addressed.

The Appeal Board noted the comments in the report of the audit about Janssen’s presentation to the Appeal Board at its consideration of the report from the Code of Practice Panel (Appeal Board meeting 16 September 2021) and its response to Appeal Board questions about SPC updates at that hearing. The Appeal Board bore in mind Janssen’s comments on the report of the audit that at no stage was there an intention to mislead the PMCPA or the Appeal Board. The Appeal Board was concerned about what appeared to be an apparent lack of candour in the presentation and responses to Appeal Board questions, including about the scale of the difficulties at the company. It was important that the Appeal Board was able to rely on the accuracy of a company‘s submissions.

The Appeal Board acknowledged Janssen’s comments on the report of the audit that it was committed to addressing the matters raised in the report of the audit, together with any others discovered as part of this process, as a matter of urgency and had already initiated significant actions.

The Appeal Board decided that Janssen should be re-audited in September 2022. In addition the Appeal Board required Janssen to provide an action plan with relevant time lines by April 2022 and to provide a further updated action plan in preparation for the re-audit. On receipt of the report of the re-audit the Appeal Board would decide whether further sanctions were necessary.