Case Summary
Janssen-Cilag voluntarily admitted a breach of the Code in that a promotional email for Invokana (canagliflozin), with outdated prescribing information, was inadvertently sent to general practitioners by its mailing agency.
Invokana was indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in certain patients as monotherapy or as added-on therapy.
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 explained that the Invokana prescribing information was updated in December 2015 to reflect the addition of the uncommon side effect of 'renal failure (mainly in the context of volume depletion)' and consolidation of non-serious, uncommon side effects associated with renal failure previously listed in prescribing information (blood creatinine increased, blood urea increased, blood potassium increased, blood phosphate increased). Therefore Janssen did not believe that the outdated prescribing information had risked patient safety. A copy of the Invokana prescribing information from August 2015 and an annotated copy from December 2015, indicating the changes, were provided.
Janssen acknowledged a breach of the Code since the expired prescribing information included on the mailer was not consistent with the summary of product characteristics (SPC) at the time of publication.
The detailed response from Janssen is given below.
The Panel noted that on 7 January 2015, the agency emailed Janssen to confirm that all old versions of the Invokana prescribing information had been deleted from its system. As prescribing information was an integral part of the promotional material provided by the agency, it was assumed that deletion of old prescribing information would, at the same time, delete the materials at issue.
On 16 March there was an email exchange between the agency and Janssen regarding the 'Invokana Cost Change email'. Neither party referred to 'updated' material or cited the reference number so that the item at issue could be correctly identified. Having received confirmation that the email was approved for use it appeared that there was a verbal instruction from the agency's account team to its IT team to 'resend' the mailer. The Panel assumed that the little information given was sufficient to allow the correct item to be identified. The IT team retrieved the old mailer from the sent items on its mail server and resent it. The Panel considered that although the agency had not previously realised that material was effectively archived on its mail server, both parties should have been clearer about the item at issue particularly given the importance of not sending outdated material.
The Panel noted that, Janssen's agency had resent a previous document which included prescribing information which Janssen submitted did not reflect the most recent SPC. The company had updated its prescribing information by consolidating a previous list of what it described as non-serious, uncommon side effects associated with renal failure into the statement 'renal failure (mainly in the context of volume deletion)'.
The Code required the prescribing information to be included in promotional material and the supplementary information stated that the prescribing information must be consistent with the SPC. Clause 4.2 listed the elements of the prescribing information and in relation to adverse reactions the requirement was for a succinct statement of common adverse reactions likely to be encountered in clinical practice, serious adverse reactions and precautions and contra-indications relevant to the indications in the advertisement, giving in abbreviated form, the substance of the relevant information in the SPC, together with a statement that prescribers should consult the SPC in relation to other adverse reactions.
The Panel noted that the adverse reaction at issue was neither common nor, according to Janssen, serious. In that regard it was not one of the required elements of prescribing information listed in Clause 4.2. Nonetheless, information even about uncommon side effects still had to be accurate. The Panel noted that the change made to the Invokana prescribing information in December 2015 was to consolidate a list of conditions symptomatic of renal failure. The email sent in error included that list instead of the consolidated statement 'renal failure (mainly in the context of volume depletion)'. The Panel considered that although the prescribing information on the email sent in March 2015 was not the most up-to-date version, prescribers had nonetheless been given the substance of the relevant information in the SPC as required. No breach was ruled
CASE AUTH/2835/4/16 NO BREACH OF THE CODE
VOLUNTARY ADMISSION BY JANSSEN
Invokana email
Janssen-Cilag voluntarily admitted a breach of the Code in that a promotional email for Invokana (canagliflozin), with outdated prescribing information, was inadvertently sent to general practitioners by its mailing agency.
Invokana was indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in certain patients as monotherapy or as added-on therapy.
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 explained that the Invokana prescribing information was updated in December 2015 to reflect the addition of the uncommon side effect of ‘renal failure (mainly in the context of volume depletion)’ and consolidation of non-serious, uncommon side effects associated with renal failure previously listed in prescribing information (blood creatinine increased, blood urea increased, blood potassium increased, blood phosphate increased). Therefore Janssen did not believe that the outdated prescribing information had risked patient safety. A copy of the Invokana prescribing information from August 2015 and an annotated copy from December 2015, indicating the changes, were provided.
Janssen acknowledged a breach of the Code since the expired prescribing information included on the mailer was not consistent with the summary of product characteristics (SPC) at the time of publication.
The detailed response from Janssen is given below.
The Panel noted that on 7 January 2015, the agency emailed Janssen to confirm that all old versions of the Invokana prescribing information had been deleted from its system. As prescribing information was an integral part of the promotional material provided by the agency, it was assumed that deletion of old prescribing information would, at the same time, delete the materials at issue.
On 16 March there was an email exchange between the agency and Janssen regarding the ‘Invokana Cost Change email’. Neither party referred to ‘updated’ material or cited the reference number so that the item at issue could be correctly identified. Having received confirmation that the email was approved for use it appeared that there was a verbal instruction from the agency’s account team to its IT team to ‘resend’ the mailer. The Panel assumed that the little information given was sufficient to allow the correct item to be identified. The IT team retrieved the old mailer from the sent items on its mail server and resent it. The Panel considered that although the agency had not previously realised that material was effectively archived on its mail server, both parties should have been clearer about the item at issue particularly given the importance of not sending outdated material.
The Panel noted that, Janssen’s agency had resent a previous document which included prescribing information which Janssen submitted did not reflect the most recent SPC. The company had updated its prescribing information by consolidating a previous list of what it described as non-serious, uncommon side effects associated with renal failure into the statement ‘renal failure (mainly in the context of volume deletion)’.
The Code required the prescribing information to be included in promotional material and the supplementary information stated that the prescribing information must be consistent with the SPC. Clause 4.2 listed the elements of the prescribing information and in relation to adverse reactions the requirement was for a succinct statement of common adverse reactions likely to be encountered in clinical practice, serious adverse reactions and precautions and contra-indications relevant to the indications in the advertisement, giving in abbreviated form, the substance of the relevant information in the SPC, together with a statement that prescribers should consult the SPC in relation to other adverse reactions.
The Panel noted that the adverse reaction at issue was neither common nor, according to Janssen, serious. In that regard it was not one of the required elements of prescribing information listed in Clause 4.2. Nonetheless, information even about uncommon side effects still had to be accurate. The Panel noted that the change made to the Invokana prescribing information in December 2015 was to consolidate a list of conditions symptomatic of renal failure. The email sent in error included that list instead of the consolidated statement ‘renal failure (mainly in the context of volume depletion)’. The Panel considered that although the prescribing information on the email sent in March 2015 was not the most up-to-date version, prescribers had nonetheless been given the substance of the relevant information in the SPC as required. No breach was ruled.
Janssen-Cilag Ltd voluntarily admitted a breach of the Code in that a promotional email for Invokana (canagliflozin) (ref PHGB/VOK/1015/0078), with outdated prescribing information, was inadvertently sent to general practitioners by its mailing agency.
Invokana was indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in certain patients as monotherapy or as added-on therapy.
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.
VOLUNTARY ADMISSION
Janssen stated that a withdrawn mailing was sent in error. The mailing agency had taken complete responsibility for the error which was caused by miscommunication between its account team and its information technology (IT) team. The agency brought the error to Janssen’s attention almost immediately after the mailer was sent.
On 22 March, the agency apologised sincerely to Janssen for distributing a previously withdrawn campaign mailer with outdated prescribing information instead of the updated version with current prescribing information (ref PHGB/ VOK/1015/0078(1)).
Janssen explained that the Invokana prescribing information was updated in December 2015 to reflect the addition of the uncommon side effect of ‘renal failure (mainly in the context of volume depletion)’ and consolidation of non-serious, uncommon side effects associated with renal failure previously listed in prescribing information (blood creatinine increased, blood urea increased, blood potassium increased, blood phosphate increased). Therefore Janssen did not believe that the outdated prescribing information had risked patient safety. A copy of the Invokana prescribing information from August 2015 and an annotated copy from December 2015, indicating the changes, were provided.
The timeline was as follows:
- 7 January – The agency wrote to confirm that all digital and print material had been updated with the latest prescribing information and the old prescribing information had been deleted from its systems. This confirmation was within the timeline specified in the Janssen Withdrawal of Materials standard operating procedure (SOP).
- 14 March – Janssen certified the updated mailer (ref PHGB/VOK/1015/0078(1))
- 16 March – Janssen emailed the agency to confirm that the updated material was certified and ready to be distributed.
- 22 March – Agency incorrectly sent outdated mailer
- 23 March – Agency sent out version with current prescribing information and subject line to highlight previous version was sent in error (ref PHGB/VOK/1015/0078 (1)a).
Janssen stated that it requested immediate investigations and corrective and preventative actions from its agency to prevent similar mistakes in the future. The agency reported that the error had resulted from confusion between its account and IT teams, where the account team requested the mailer to be ‘resent’ and the IT team resent the previous mailer instead of the certified updated version. As preventative measures the agency confirmed all client sponsored emails would be deleted from its email server one week post-send to prevent an outdated mailer mistakenly being sent again. The agency also confirmed a process was in place where all client sponsored emails would be classed as new and any allusion to ‘resend’ would only be reflected in the data to match the requirements.
Janssen acknowledged a breach of Clause 4.1, since the expired prescribing information included on the mailer was not consistent with the summary of product characteristics (SPC) at the time of publication. Janssen had contacted the PMCPA proactively about this incident. To date it had not received any complaints from recipients or ABPI member companies.
Janssen submitted that it took its responsibilities under the Code very seriously and sincerely regretted the actions taken by its agency. It had registered its dissatisfaction with the agency which had confirmed in writing that a process was in place to prevent future outdated mailers being emailed in error.
Following its internal review Janssen was satisfied that its SOP for Withdrawal of Materials and ReApproval had been adhered to and that this incident had occurred due to a mistake by its agency.
RESPONSE
Janssen provided a copy of the email sent to the agency on 16 March, confirming that the updated job bag was certified and approved for use. Additionally, Janssen hoped the following summary would aid clarification:
- On 7 January the agency confirmed that new Invokana prescribing information was received and previous versions destroyed (see below).
- The correct material (ref PHGB/VOK/1015/0078(1)) was created by the agency and review was commenced on 22 January 2016; the agency uploaded the final artwork on 29 February 2016. This artwork was subsequently reviewed, amended, approved then certified by Janssen on 14 March with the correct prescribing information.
- Once certification had taken place, the agency was informed that the material (ref PHGB/ VOK/1015/0078(1)) was approved for distribution on 16 March.
- On 22 March, the agency distributed the old mailer (ref PHGB/VOK/1015/0078) which contained the outdated prescribing information retrieved by its IT team from the ‘sent items’ from previous email distribution.
- The agency acknowledged that the ‘Cost Change Email’ (ref PHGB/VOK/1015/0078) should not have been sent on 22 March. The correct job bag number that Janssen requested to be sent was PHGB/VOK/1015/0078(1).
- Subsequent to Janssen’s voluntary admission above, the agency had confirmed that before sending a promotional email on behalf of a client, it usually confirmed certification of the job bag firstly by email or telephone call to the sponsoring company to confirm approval to send and secondly, verification in Zinc Unitas approval system to confirm certification. Due to the error, the agency had now implemented an additional process, by which promotional items contained in emails in the ‘sent items’ were deleted after one week.
In relation to why an email from the agency dated 22 March to Janssen referred to deletion of old versions of the Invokana prescribing information rather than specific materials, Janssen submitted that the prescribing information for Invokana was changed in December 2015 and the agency was informed of this change on 7 January 2016, within the Janssen SOP timeframe for this process. This communication included a request to delete copies of the former prescribing information. The agency wrote to Janssen on 7 January to confirm compliance with this request.
Promotional items produced by the agency were approved with an integrated prescribing information and so an instruction to delete the prescribing information would mean the entire promotional item would be deleted.
On 22 March, the agency distributed the incorrect item (ref PHGB/VOK/1015/0078), because its IT team sourced a version of the previous item from the ‘sent items’ server. The agency identified the error immediately and instigated a process to resolve the hitherto unknown source of archived material by ensuring all client sponsored emails in the ‘sent item’ repository on the server were deleted one week post mailing.
Janssen reiterated that it took its responsibilities under the Code very seriously. It had worked with the agency to ensure its processes were corrected so similar errors did not affect Janssen or other industry partners in the future. It sincerely regretted that it might have breached Clause 4.1 and was acutely aware that this was its second voluntary admission regarding a breach of that Clause. In this case, the company was satisfied that its SOP was followed and that this unfortunate error occurred as a result of agency error.
PANEL RULING
The Panel noted that on 7 January 2015, the agency emailed Janssen to confirm that all old versions of the Invokana prescribing information had been deleted from its system. As prescribing information was an integral part of the promotional material provided by the agency, it was assumed that deletion of old prescribing information would, at the same time, delete the materials at issue.
On 16 March there was an email exchange between the agency and Janssen regarding the ‘Invokana Cost Change email’. Neither party referred to ‘updated’ material or cited the reference number of the updated email so that the item at issue could be correctly identified. Having received confirmation that the email was signed off and approved for use it appeared that there was a verbal instruction from the agency’s account team to its IT team to ‘resend’ the mailer. The Panel assumed that the little information given was sufficient to allow the correct item to be identified. The IT team retrieved the old mailer from the sent items on its mail server and resent it. The Panel considered that although the agency had not previously realised that material was effectively archived on its mail server, both parties should have been clearer about the item at issue particularly given the importance of not sending outdated material.
The Panel noted that, Janssen’s agency had resent a previous document which included prescribing information which Janssen submitted did not reflect the most recent SPC. The company had updated its prescribing information by consolidating a previous list of what it described as non-serious, uncommon side effects associated with renal failure into the statement ‘renal failure (mainly in the context of volume deletion)’.
The Panel noted that Clause 4.1 required the prescribing information to be included in promotional material and the supplementary information stated that ‘The prescribing information must be consistent with the summary of product characteristics for the medicine’. Clause 4.2 listed the elements of the prescribing information and in relation to adverse reactions the requirement was for a succinct statement of common adverse reactions likely to be encountered in clinical practice, serious adverse reactions and precautions and contra-indications relevant to the indications in the advertisement, giving in abbreviated form, the substance of the relevant information in the SPC, together with a statement that prescribers should consult the SPC in relation to other adverse reactions.
The Panel noted that the adverse reaction at issue was neither common nor, according to Janssen, serious. In that regard it was not one of the required elements of prescribing information listed in Clause 4.2. Nonetheless, information even about uncommon side effects still had to be accurate. The Panel noted that the change made to the Invokana prescribing information in December 2015 was to consolidate a list of conditions symptomatic of renal failure. The email sent in error included that list instead of the consolidated statement ‘renal failure (mainly in the context of volume depletion)’. The Panel considered that although the prescribing information on the email sent in March 2015 was not the most up-to-date version, prescribers had nonetheless been given the substance of the relevant information in the SPC as required by Clause 4.2. No breach of Clause 4.1 was thus ruled.
Complaint received 13 April 2016
Case completed 13 May 2016
