Case Summary
Britannia Pharmaceuticals Ltd made a voluntary admission about incorrect prescribing information on the APO-go (apomorphine hydrochloride) website which was developed by a third-party contractor. The third party was, according to Britannia, responsible for hosting the APO-go website, the execution of the general design and layout of the website and making amendments to content when requested by Britannia. Britannia had no back-end access to the website.
Britannia stated that the most recent change to the webpage content was in November 2021 to the healthcare professional/patient/general public landing page. The previous update was in June 2021.
On 1 February 2022 the Britannia compliance team noticed that the pdfs available in the ‘Resources’ tab under the ‘Healthcare Professional (HCP) only’ section of the website could be accessed directly from Google when ‘Crono pump’ or ‘APO-go pen’ were typed in the search engine. The material was intended to be downloaded by the health professional and then provided to patients prescribed APO-go, to educate them on the use of the device.
Britannia stated that on investigation the third party confirmed that a new developer uploaded the updated versions of the materials, however, when completing the update, the developer accidently left the access to the new versions of the pdfs open via the backend. Britannia confirmed that these materials were non-promotional and had no risk to patient safety.
On becoming aware of the issue Britannia immediately contacted the third party agency to remove the old pdf version of the material from the server and remove access to the new pdf versions of the materials that could be accessed through Google search engine.
The third party actioned the above immediately, however, during this process, the third party inadvertently removed the prescribing information document from the server but did not inform Britannia as the error was unknown to the third party. The prescribing information tab was available at the bottom of the landing page. However, when clicking on it, the prescribing information was inaccessible and an error message was seen on the page.
On 2 February, Britannia identified that the prescribing information was inaccessible via a spot check and contacted the third party immediately to reinstate the prescribing information which was done that day.
Britannia provided details of the actions taken and the preventative measures that had been put in place.
Britannia submitted that the third party reinstated the prescribing information within two hours of Britannia becoming aware of the issue. This was an error wholly made by the third party and not one instructed or made by Britannia, although the company accepted that it had responsibility for third party contracts. Hence why Britannia made the voluntary submission.
The detailed response from Britannia is given below.
The Panel noted that neither Britannia nor its third party were aware that the APO-go prescribing information was inadvertently removed by the third party whilst the errors described below were corrected. This resulted in the prescribing information being unavailable on the Britannia APO-go promotional website, albeit for a short period of time. The Panel therefore ruled a breach of the Code as acknowledged by the company.
In relation to the clauses raised by the case preparation manager, the Panel noted that on 1 February 2022, the Britannia compliance team noted that three documents available in the ‘Resources tab’ under the ‘Healthcare Professional (HCP) only’ section of the website, could be accessed directly from Google search engine when ‘Crono pump’ or ‘APO-go pen’ were typed as keywords. According to Britannia, when uploading the updated versions of the materials, the third party accidently left access to these new pdf versions open via the backend. They were not intended to be disseminated on a public domain.
The documents were according to Britannia non-promotional device guidance materials which were intended to be downloaded by health professionals to provide to patients when they were prescribed APO-go to educate them on the use of the device.
The Panel noted that whilst the three old versions of the documents had been withdrawn from the APO-go website, they were accidently not removed from the backend server by the website developer. These old versions of the documents were available in the public domain when proactively searched but were not available on the APO-go website. In that regard, it seemed reasonable to consider that the documents were on an internal company page rather than one which was intended for an external audience including the public.
The Panel, noting its comments above, decided that in the particular circumstances of this case, the now out-of-date yellow card link on the three old versions of the documents which were not ‘live’ on the company website did not amount to a breach of the Code. No breach of the Code was ruled.
Similarly, although it was unfortunate that the three old versions of the documents could be accessed by members of the public via Google, the Panel noted that they could not be accessed directly from Britannia’s website; they were stored in an area that was not intended to be accessible to users outside of the company. On balance, the Panel considered that the circumstances of this case the three old versions of the documents, which had been removed from the APO-go website but which had unintentionally, and unknown to Britannia, remained directly accessible by Google, did not amount to the promotion of a prescription-only medicine to the public. No breach of the Code was ruled.
The Panel noted Britannia’s submission that it changed the medical information number and that both the old version of the ‘Pump Programming Guide’ and new version of the document ‘Infusion Programming Guide’ had the old number. The Panel further noted Britannia’s submission that both numbers were currently active with the old number automatically redirected to the new number to ensure that no enquiries were missed. The Panel decided that in the particular circumstances of this case, the old medical information number still being available on old and new versions of the documents at issue did not amount to a failure to maintain high standards and no breach of the Code was ruled.
In relation to the three new versions of the documents that could be accessed via google search, the Panel noted that they were live on the APO-go website. The Panel further noted Britannia’s submission that these materials could only be accessed when keywords, such as ‘Crono pump’ or ‘APO-go pen’, were proactively searched in Google. According to Britannia as these keywords were typically used by patients or prescribers who were familiar with the product, it would be highly unlikely for members of the public to come across these materials without proactively searching using the keywords in Google search engine. In order to access such materials on the APO-go website, users needed to confirm that they were a health professional. Communications between Britannia and the third party in May 2021 stated that the ‘Are you an HCP’ banner was not visible from Google from all pages and Britannia requested that the third party add the health professional link to all Google entry points. It appeared from this communication that when accessing the APO-go PEN link from Google, the health professional pop up appeared and when it did not it was noted that this was probably because the user had already visited the site previously and confirmed that they were a health professional which the site remembered. The Panel did not consider that there was evidence to show that a Google search for ‘Crono pump’ or ‘APO-go pen’ took browsers straight to the three new versions of the documents without a health professional declaration. The Panel, noting its comments above, did not consider that prescription only medicines had been promoted to the public. The Panel ruled no breach of the Code.
In the Panel’s view, this case illustrated that companies should exercise extreme caution and, wherever possible, ensure that material which was withdrawn from use was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company.
The Panel noted Britannia’s submission that it took immediate action to correct the issues when becoming aware of them. Although concerned that at the time of the complaint the three old versions of the documents could still be found via a Google search as well as the three new versions, given its comments and rulings above, the Panel considered that, in the specific circumstances of this case, the company had not failed to maintain high standards. No breach of the Code was ruled. The Panel consequently ruled no breach of Clause 2.
CASE AUTH/3609/2/22
VOLUNTARY ADMISSION BY BRITANNIA PHARMACUETICALS
Incorrect prescribing information on the APO-go website
Britannia Pharmaceuticals Ltd made a voluntary admission about incorrect prescribing information on the APO-go (apomorphine hydrochloride) website which was developed by a third-party contractor. The third party was, according to Britannia, responsible for hosting the APO-go website, the execution of the general design and layout of the website and making amendments to content when requested by Britannia. Britannia had no back-end access to the website.
Britannia stated that the most recent change to the webpage content was in November 2021 to the healthcare professional/patient/general public landing page. The previous update was in June 2021.
On 1 February 2022 the Britannia compliance team noticed that the pdfs available in the ‘Resources’ tab under the ‘Healthcare Professional (HCP) only’ section of the website could be accessed directly from Google when ‘Crono pump’ or ‘APO-go pen’ were typed in the search engine. The material was intended to be downloaded by the health professional and then provided to patients prescribed APO-go, to educate them on the use of the device.
Britannia stated that on investigation the third party confirmed that a new developer uploaded the updated versions of the materials, however, when completing the update, the developer accidently left the access to the new versions of the pdfs open via the backend. Britannia confirmed that these materials were non-promotional and had no risk to patient safety.
On becoming aware of the issue Britannia immediately contacted the third party agency to remove the old pdf version of the material from the server and remove access to the new pdf versions of the materials that could be accessed through Google search engine.
The third party actioned the above immediately, however, during this process, the third party inadvertently removed the prescribing information document from the server but did not inform Britannia as the error was unknown to the third party. The prescribing information tab was available at the bottom of the landing page. However, when clicking on it, the prescribing information was inaccessible and an error message was seen on the page.
On 2 February, Britannia identified that the prescribing information was inaccessible via a spot check and contacted the third party immediately to reinstate the prescribing information which was done that day.
Britannia provided details of the actions taken and the preventative measures that had been put in place.
Britannia submitted that the third party reinstated the prescribing information within two hours of Britannia becoming aware of the issue. This was an error wholly made by the third party and not one instructed or made by Britannia, although the company accepted that it had responsibility for third party contracts. Hence why Britannia made the voluntary submission.
The detailed response from Britannia is given below.
The Panel noted that neither Britannia nor its third party were aware that the APO-go prescribing information was inadvertently removed by the third party whilst the errors described below were corrected. This resulted in the prescribing information being unavailable on the Britannia APO-go promotional website, albeit for a short period of time. The Panel therefore ruled a breach of the Code as acknowledged by the company.
In relation to the clauses raised by the case preparation manager, the Panel noted that on 1 February 2022, the Britannia compliance team noted that three documents available in the ‘Resources tab’ under the ‘Healthcare Professional (HCP) only’ section of the website, could be accessed directly from Google search engine when ‘Crono pump’ or ‘APO-go pen’ were typed as keywords. According to Britannia, when uploading the updated versions of the materials, the third party accidently left access to these new pdf versions open via the backend. They were not intended to be disseminated on a public domain.
The documents were according to Britannia non-promotional device guidance materials which were intended to be downloaded by health professionals to provide to patients when they were prescribed APO-go to educate them on the use of the device.
The Panel noted that whilst the three old versions of the documents had been withdrawn from the APO-go website, they were accidently not removed from the backend server by the website developer. These old versions of the documents were available in the public domain when proactively searched but were not available on the APO-go website. In that regard, it seemed reasonable to consider that the documents were on an internal company page rather than one which was intended for an external audience including the public.
The Panel, noting its comments above, decided that in the particular circumstances of this case, the now out-of-date yellow card link on the three old versions of the documents which were not ‘live’ on the company website did not amount to a breach of the Code. No breach of the Code was ruled.
Similarly, although it was unfortunate that the three old versions of the documents could be accessed by members of the public via Google, the Panel noted that they could not be accessed directly from Britannia’s website; they were stored in an area that was not intended to be accessible to users outside of the company. On balance, the Panel considered that the circumstances of this case the three old versions of the documents, which had been removed from the APO-go website but which had unintentionally, and unknown to Britannia, remained directly accessible by Google, did not amount to the promotion of a prescription-only medicine to the public. No breach of the Code was ruled.
The Panel noted Britannia’s submission that it changed the medical information number and that both the old version of the ‘Pump Programming Guide’ and new version of the document ‘Infusion Programming Guide’ had the old number. The Panel further noted Britannia’s submission that both numbers were currently active with the old number automatically redirected to the new number to ensure that no enquiries were missed. The Panel decided that in the particular circumstances of this case, the old medical information number still being available on old and new versions of the documents at issue did not amount to a failure to maintain high standards and no breach of the Code was ruled.
In relation to the three new versions of the documents that could be accessed via google search, the Panel noted that they were live on the APO-go website. The Panel further noted Britannia’s submission that these materials could only be accessed when keywords, such as ‘Crono pump’ or ‘APO-go pen’, were proactively searched in Google. According to Britannia as these keywords were typically used by patients or prescribers who were familiar with the product, it would be highly unlikely for members of the public to come across these materials without proactively searching using the keywords in Google search engine. In order to access such materials on the APO-go website, users needed to confirm that they were a health professional. Communications between Britannia and the third party in May 2021 stated that the ‘Are you an HCP’ banner was not visible from Google from all pages and Britannia requested that the third party add the health professional link to all Google entry points. It appeared from this communication that when accessing the APO-go PEN link from Google, the health professional pop up appeared and when it did not it was noted that this was probably because the user had already visited the site previously and confirmed that they were a health professional which the site remembered. The Panel did not consider that there was evidence to show that a Google search for ‘Crono pump’ or ‘APO-go pen’ took browsers straight to the three new versions of the documents without a health professional declaration. The Panel, noting its comments above, did not consider that prescription only medicines had been promoted to the public. The Panel ruled no breach of the Code.
In the Panel’s view, this case illustrated that companies should exercise extreme caution and, wherever possible, ensure that material which was withdrawn from use was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company.
The Panel noted Britannia’s submission that it took immediate action to correct the issues when becoming aware of them. Although concerned that at the time of the complaint the three old versions of the documents could still be found via a Google search as well as the three new versions, given its comments and rulings above, the Panel considered that, in the specific circumstances of this case, the company had not failed to maintain high standards. No breach of the Code was ruled. The Panel consequently ruled no breach of Clause 2.
Britannia Pharmaceuticals Ltd made a voluntary admission about incorrect prescribing information on the APO-go (apomorphine hydrochloride) website which was developed by a third-party contractor. The third party was, according to Britannia, responsible for hosting the APO-go website, the execution of the general design and layout of the website and making any amends to the contents of the website whenever change was requested by Britannia. Britannia had no back-end access to the website.
VOLUNTARY ADMISSION
Britannia stated that following the introduction of the APO-go.com website, several quality improvements had been made to the website contents. The most recent change to the webpage content was in November 2021 to the healthcare professional/patient/general public landing page. The last time that documents were updated on the website was in June 2021.
On 1 February 2022 the compliance team noticed that the pdfs available in the ‘Resources’ tab under the ‘Healthcare Professional (HCP) only’ section of the website could be accessed directly from Google when ‘Crono pump’ or ‘APO-go pen’ were typed in the search engine. These were non-promotional guidance materials which were intended to be downloaded by the health professional and then provided to patients prescribed APO-go, to educate them on the use of the device.
Britannia stated that on investigation the third party confirmed that a new developer uploaded the updated versions of the materials, however, when completing the update, the developer accidently left the access to the new versions of the pdfs open via the backend. To confirm these materials were non-promotional and had no risk to patient safety.
On becoming aware of the website issue Britannia immediately contacted the third party to:
a) remove the old pdf version of the material from the server;
b) remove access to the new pdf versions of the materials that could be accessed through Google search engine.
The third party actioned the above immediately, however, during this rectification process, they inadvertently removed the prescribing information document from the server but had not informed Britannia as the error was unknown to the third party. The prescribing information tab was available at the bottom of the landing page, however, when clicking on it, the prescribing information was inaccessible and an error message was seen on the page.
On 2 February, Britannia identified that the prescribing information was inaccessible via a spot check and contacted the third party immediately to reinstate the prescribing information which was reinstated on the website on 2 February.
Immediate Actions Taken:
• On 1 February, Britannia immediately contacted the third party to remove the old pdf version of the material from the server.
• Britannia instructed the third party to remove access to the new pdf versions of the materials that could be accessed through the Google search engine.
• On becoming aware that the prescribing information was not available on 2 February, Britannia immediately contacted the third party to reinstate the access to the prescribing information on the website.
• Britannia conducted a risk assessment on 3 February by checking the contents of the old version of the material against the new version. The following observations were made:
o The old version did not have the updated medical information (MI) contact number and the Yellow Card Adverse Event (AE) Reporting link was not up to date. However, if anyone contacted on the old medical information number, they would be redirected to the new number. This redirection of calls ensured that no enquiries were missed. The old Yellow Card AE Reporting link was redirected to the new link by the MHRA.
o Both old and new versions were non-promotional materials.
o The APO-go Helpline number remained the same in both versions.
o Britannia requested that the third party provide a full incident report which covered details of cross-checks made on the entire APO-go website to ensure that all links were working as expected and no materials or files of the website were currently accessible to the general public through Google search engine, without first providing proof of health professional status. Also, ensured all materials available on the website and backend server were up-to-date and old versions were deleted.
Preventive measures:
• Britannia had requested the third party to conduct regular monitoring of the website to ensure there were no broken links, materials were up-to-date and accessible only to health professionals.
• Britannia had asked the third party to provide training plans/standard operating procedures (SOPs) for new team members.
• Britannia Compliance Team would provide basic ABPI training to the third party.
• The third party had committed to improve the way pdfs were stored on their server, to ensure that no documents or files were publicly accessible. Furthermore, a tick box to confirm the health professional status before downloading the pdfs would be implemented.
• Britannia planned to move away from the third party during 2022.
Britannia submitted that, as per Clause 12.1, ‘The prescribing information must form part of the promotional material and must not be separate from it’. Britannia accepted that it was in breach of Clause 12.1 as the prescribing information was inaccessible for 24 hours on a promotional website. The third party reinstated the prescribing information within two hours of Britannia becoming aware of the issue. This was an error wholly made by the third party and not one instructed or made by Britannia, although the company accepted that it had responsibility for third party contracts. Hence why Britannia made the voluntary submission.
When writing to Britannia, the Authority asked it to consider the requirements of Clause 12.1 of the 2021 Code. In addition, Britannia was asked to consider Clause 26.1 in relation to the patient material for those prescribed the product in question within the health professional section being accessible to the public via a Google search, Clause 26.4 in relation to the omission of the adverse event reporting link on the old pdf, and Clause 5.1 in relation to the incorrect medical information contact number on the old pdf. The company was also asked to respond in relation to the cumulative effect of the admissions and Clauses 5.1 and 2.
RESPONSE
Britannia submitted that it’s APO-go (apomorphine) product website was developed and maintained by a third party contractor. On 1 February 2022, the compliance team noticed that three pdfs available in the ‘Resources’ tab under the ‘Healthcare Professional (HCP) only’ section of the website, could be accessed directly from Google search engine when ‘Crono pump’ or ‘APO-go pen’ were typed as keywords. These pdfs were non-promotional device guidance materials which were intended to be downloaded by health professionals and then provided to patients when they were prescribed APO-go. These guides were provided as reference materials to educate patients on the use of the device. Upon investigation, Britannia was informed by the third party that when the new versions of 3 pdfs were uploaded, the old pdf versions of these 3 materials were accidently not removed from the backend server by the website developer. To confirm, the old pdfs were not available on the website.
The third party actioned the above errors immediately when instructed by Britannia on 1 February 2022, however, during this rectification process, they inadvertently removed the prescribing information from the server. Britannia was not informed of this error as it was unknown to the third party. The prescribing information tab was available at the bottom of the website landing page, however, when clicking on it, the prescribing information was inaccessible and an error message was seen on the page due to the document being removed from the server.
On 2 February, Britannia identified that the prescribing information was inaccessible, following the remediation steps, and the company contacted the third party immediately to reinstate the prescribing information which was reinstated on the website within two hours of notification.
Clause 12.1:
Britannia submitted that whilst the third party was rectifying the issue with the three non-promotional materials, it accidently removed the pdf version of the prescribing information which was stored in the server. The prescribing information tab was still available at the bottom of the website, however, when clicking on it, the prescribing information was inaccessible and an error message was seen on the page due to the document being removed on the server.
Britannia accepted that this was in breach of Clause 12.1 where the prescribing information was inaccessible for a period of over 24 hours on a promotional website hence, Britannia submitted a voluntary admission to the PMCPA on 8 February 2022.
As the website was also accessed by patients who were prescribed APO-go, Britannia decided not to shut down the website instantaneously, because this would impact patient safety as they would be unable to access the website or the Helpline number. Britannia understood that having no access to prescribing information was a Code breach, and hence requested that the third party immediately reinstated the prescribing information. The prescribing information was reinstated within two hours of Britannia becoming aware of this issue.
Clause 26.1:
Britannia noted that the three new and three old device guidance pdf versions were available on the public domain when proactively searched. These were non-promotional guidance materials for the use of a device that were intended to be downloaded by a healthcare professional and then shared with patients when they were prescribed APO-go. These were educational materials which guided patients on the use of the Crono device and APO-go pen.
Britannia submitted that the non-promotional materials complied with Clause 26 of the Code as they were ‘Reference Information’ material and:
o The content of the material was factual and presented in a balanced way (Clause 26.2).
o It did not raise any unfounded hopes of successful treatment or was misleading with respect to the safety of the product (Clause 26.2).
o There were no statements made that encouraged members of the public to ask their HCP to prescribe APO-go as these were device guidance materials (Clause 26.2).
Britannia noted that although these were non-promotional materials related to the use of a device for patients who had been prescribed APO-go, they were not intended to be disseminated on a public domain. In order to access such materials on the APO-go website, users needed to confirm that they were a health professional.
Britannia noted that these non-promotional patient materials were publicly accessible via Google when proactively searched using keywords. It was a genuine and unfortunate accident due to human error by the website developer, the device materials were non-promotional in nature and did not encourage use of Britannia’s prescription only medicine (POM). To confirm, these materials were not proactively advertised in the public domain. Thus, Britannia refuted the breach of Clause 26.1.
Clause 26.4:
During the internal investigation conducted by Britannia Compliance Team, it was identified on 2 February 2022 that the Yellow Card Adverse Event (AE) reporting link in the three old versions of the materials was not up to date, however, Britannia was aware that the old AE reporting link was redirected to the new link by the MHRA. To clarify, these materials were only available when searched proactively via Google using keywords. To confirm, the three new updated pdf versions with the updated Yellow Card AE reporting details were always available on the APO-go website.
According to Clause 26.4: ‘Any material which relates to a medicine and which is intended for patients taking that medicine must include the statement below or a similar one: 'Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at [a website address which links directly to the MHRA Yellow Card site]. By reporting side effects, you can help provide more information on the safety of this medicine’.
The supplementary information to Clause 26.4 stated: ‘In the event that the website address given in Clause 26.4 is changed by the MHRA, companies must use the new address within one year of the change’.
Britannia updated the materials with the new link last year. Although, the third party had uploaded the new version of the materials on the server and the website, the old versions with the incorrect Yellow Card AE reporting link were still accessible publicly via Google using keywords. Britannia clarified that the AE reporting link was not omitted from the old pdf versions and the materials had the old MHRA AE reporting link.
Britannia did not intend for these three old pdfs to be accessible publicly at any given point the website developer at the third party uploaded the new versions, however, due to human error the old versions were still left in the backend server despite confirmation that the files were deleted. The access to these pdfs were left open in the server and hence they could be accessed via Google using keywords. To clarify, the old versions were not accessible on the APO-go website; only the new three pdfs were available.
Thus, Britannia refuted the breach of Clause 26.4.
Clause 5.1:
Britannia changed its medical information (MI) number from 01483 920 763 to 0808 196 8585 in May 2021. Both numbers were currently active. The 01483 number was automatically redirected to the 0808 number. This redirection ensured that no enquiries were missed. When a customer called the 01483 920 763 number, the call went straight to Britannia’s medical information team. As all calls from this number were diverted to medical information no calls were missed thus, patient safety was not compromised.
Britannia confirmed that both the old pdf ‘Pump Programming Guide’ and the new pdf ‘Infusion Programming Guide’ had the 01483 920 763 number. As this number was still active and calls were being redirected to medical information, this number was not incorrect on both versions of the materials.
Britannia noted that this might not be the up-to date medical information number, however, it intended to update the materials with the 0808 196 8585 medical information number during its next scheduled revision of the ‘Infusion Programming Guide’ which would be complete by the end of 2022. In the meanwhile, both numbers remained accessible to patients.
Thus, Britannia refuted the breach of Clause 5.1 in relation to the incorrect medical information contact number on the old pdf.
Clauses 5.1 (cumulative) and 2:
Britannia submitted that when it became aware of the website issues, it took immediate actions to correct them and immediately conducted an internal investigation, to check the contents of the old version of the materials against the new versions to ensure patient safety was not compromised. Britannia requested a full incident report from the third party which covered details of cross-checks made on the entire APO- go website to ensure that all links were working as expected and no website material was accessible to the public through Google, without first providing proof of healthcare professional status.
Additionally, the third party confirmed that all materials available on the website and backend server were up-to date and old versions were deleted.
Britannia acknowledged the breach of Clause 12.1 in relation to lack of access to the prescribing information on a promotional website for over 24 hours. The email trail demonstrated that the prescribing information was reinstated within two hours of Britannia becoming aware of the issue. To reiterate, the PI tab was still available at the bottom of the website, however, when clicking on it, the prescribing information was inaccessible and an error message was seen on the page due to the document being removed on the server.
Britannia assured the Panel that the patient materials were not readily accessible to the public. The materials could only be accessed when keywords, such as ‘Crono pump’ or ‘APO-go pen’, were proactively searched in Google. As these keywords were typically used by patients or prescribers who were familiar with the product, it would be highly unlikely for members of the public to come across these materials without proactively searching using the keywords in Google search engine.
Britannia emphasised that the new pdf versions were accessible on the website and had the updated AE reporting link. The AE reporting link was not omitted from the old pdf versions and the materials had the old MHRA AE reporting link. Since the old link redirected to the new AE reporting link, Britannia was confident that patient safety was not compromised.
Britannia confirmed that both medical information numbers were active. The medical information number details were not incorrect, and it intended to update the materials with the new number during the next revision.
Britannia never intended to provide the patient materials to members of the public via Google. The lack of access to the prescribing information was due to an unfortunate accident by the third party. Although, this issue had occurred due to the negligence of the agency, Britannia took full responsibility for a breach of Clauses 12.1. However, it refuted breaches of Clauses 26.1, 26.4 and 5.1 and 2.
Britannia stated that it was fully committed to ensuring all its materials for prescription-only medicines were of the highest standard and it strove to abide by the Code. As a preventive measure, Britannia had requested the third party to conduct regular monitoring of the website to ensure there were no broken links and materials were up-to date and accessible only to healthcare professionals. On this occasion Britannia’s Compliance Team would provide Code training to the third party and had requested a full incident report which covered details of cross-checks made on the entire APO-go website to ensure that all links were working as expected and no materials or files of the website were currently accessible to the general public through Google, without first providing proof of health professional status. The third party had committed to improve the way pdfs were stored on its server, to ensure that no documents or files were publicly accessible.
Britannia stated that the third party as it had not met contractual obligations. Britannia confirmed that the necessary steps were being taken to mitigate the omissions caused by the third party. The third party had confirmed that it deleted the prescribing information pdf without Britannia’s instructions and it was re-instated within two hours of Britannia becoming aware. The third party had now added extra protection to prevent any similar issues occurring in the future. However, Britannia had made a business decision to cease the use of the third party’s services and was currently in the process of preparing to terminate the contract and looking for suitable alternative suppliers.
Britannia submitted that the above steps were reasonable under the circumstances and the omissions caused by the third party. Having assessed the risks entailed in the failure to do as instructed, the steps being taken by Britannia were in proportion.
In summary, Britannia did not believe that it was in breach of Clause 2 of the Code and was confident that the Panel would come to the same conclusion.
PANEL RULING
The Panel noted that neither Britannia nor its third party were aware that the APO-go prescribing information was inadvertently removed by the third party whilst the errors described below were corrected. This resulted in the prescribing information being unavailable on the Britannia APO-go promotional website, albeit for a short period of time. The Panel therefore ruled a breach of Clause 12.1 of the Code as acknowledged by the company.
In relation to the clauses raised by the case preparation manager, the Panel noted that on 1 February 2022, the Britannia compliance team noted that three documents (Crono APO-go III Pump Programming Guide for APO-go INFUSION (ref UK-APOINF-2100072, Date of preparation: May 2021); Setting up the APO-go PEN (ref UK-APOINF-2100079 Date of preparation: May 2021); and Setting up the APO-go INFUSION and Crono APO-go III pump (ref UK-APOINF-2100070 Date of preparation: May 2021)) available in the ‘Resources tab’ under the ‘Healthcare Professional (HCP) only’ section of the website, could be accessed directly from Google search engine when ‘Crono pump’ or ‘APO-go pen’ were typed as keywords. According to Britannia, when uploading the updated versions of the materials, the website developer accidently left access to these new pdf versions open via the backend. The Panel noted Britannia’s submission that these three new versions of the documents were available in the public domain when proactively searched. In order to access such materials on the APO-go website, users needed to confirm that they were a health professional; they were not intended to be disseminated on a public domain.
These documents were according to Britannia non-promotional device guidance materials which were intended to be downloaded by health professionals to provide to patients as reference materials when they were prescribed APO-go to educate them on the use of the device.
The Panel noted that whilst the three old versions of the documents (Crono APO-go III Pump Programming Guide for APO-go INFUSION (ref UK-APOINF-2000033 Date of preparation: December 2020); Setting up the APO-go INFUSION and Crono APO-go III Pump (ref UK-APOINF-2000026 Date of preparation: December 2020); and Setting up the APO-go PEN (ref UK-APOINF-2000036 Date of preparation: December 2020)) had been withdrawn from the APO-go website, they were accidently not removed from the backend server by the website developer. These old versions of the documents were available in the public domain when proactively searched but were not available on the APO-go website. In that regard, it seemed reasonable to consider that the documents were on an internal company page rather than one which was intended for an external audience including the public.
Clause 26.4 Supplementary Information stated: “In the event that the website address given in Clause 26.4 is changed by the MHRA, companies must use the new address within one year of the change”. The Panel noted Britannia’s submission that although it updated the materials with the new link last year, the yellow card adverse event (AE) reporting link in the three old versions of the documents which were accessible publicly via Google using keywords was not up to date. The Panel noted Britannia’s submission that the old AE reporting link was redirected to the new link by the MHRA and the three new updated pdf versions (with the updated Yellow Card AE reporting details) were always available on the APO-go website. The Panel, noting its comments above, decided that in the particular circumstances of this case, the now out-of-date yellow card link on the three old versions of the documents which were not ‘live’ on the company website did not amount to a breach of the Code. No breach of Clause 26.4 was ruled.
Similarly, although it was unfortunate that the three old versions of the documents could be accessed by members of the public via Google, the Panel noted that they could not be accessed directly from Britannia’s website; they were stored in an area that was not intended to be accessible to users outside of the company. On balance, the Panel considered that the circumstances of this case the three old versions of the documents, which had been removed from the APO-go website but which had unintentionally, and unknown to Britannia, remained directly accessible by Google, did not amount to the promotion of a prescription-only medicine to the public. No breach of Clause 26.1 was ruled.
The Panel noted Britannia’s submission that it changed the medical information number from 01483 920 763 to 0808 196 8585 in May 2021. The Panel noted Britannia’s submission that both the old version of the ‘Pump Programming Guide’ and new version of the document ‘Infusion Programming Guide’ had the 01483 920 763 number. The Panel further noted Britannia’s submission that whilst this might not be the up-to date number and it intended to update the materials by the end of 2022, both numbers were currently active. The 01483 920 763 number was automatically redirected to the 0808 196 8585 number to ensure that no enquiries were missed. The Panel decided that in the particular circumstances of this case, the 01483 920 763 medical information number still being available on old and new versions of the documents at issue did not amount to a failure to maintain high standards and no breach of Clause 5.1 was ruled.
In relation to the three new versions of the documents that could be accessed via google search, the Panel noted that they were live on the APO-go website. The Panel further noted Britannia’s submission that these materials could only be accessed when keywords, such as ‘Crono pump’ or ‘APO-go pen’, were proactively searched in Google. According to Britannia as these keywords were typically used by patients or prescribers who were familiar with the product, it would be highly unlikely for members of the public to come across these materials without proactively searching using the keywords in Google search engine. In order to access such materials on the APO-go website, users needed to confirm that they were a health professional. Communications between Britannia and the third party in May 2021 stated that the ‘Are you an HCP’ banner was not visible from Google from all pages and Britannia requested that the third party add the HCP link to all Google entry points. It appeared from this communication that when accessing the APO-go PEN link from Google, the HCP pop up appeared and when it did not it was noted that this was probably because the user had already visited the site previously and confirmed that they were a health professional which the site remembered. The Panel did not consider that there was evidence to show that a Google search for ‘Crono pump’ or ‘APO-go pen’ took browsers straight to the three new versions of the documents without a health professional declaration. The Panel, noting its comments above, did not consider that prescription only medicines had been promoted to the public. The Panel ruled no breach of Clause 26.1.
In the Panel’s view, this case illustrated that companies should exercise extreme caution and, wherever possible, ensure that material which was withdrawn from use was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company.
The Panel noted Britannia’s submission that it took immediate action to correct the issues when becoming aware of them. Britannia requested that its third party contractor checked to ensure that all links were working as expected and no materials or files of the website were accessible to the general public through Google, without first providing proof of health professional status. Additionally, the third party contractor confirmed that all materials available on the website and backend server were up-to date and old versions were deleted. Although concerned that at the time of the complaint the three old versions of the documents could still be found via a Google search as well as the three new versions, given its comments and rulings above, the Panel considered that, in the specific circumstances of this case, the company had not failed to maintain high standards. No breach of Clause 5.1 was ruled. The Panel consequently ruled no breach of Clause 2.
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Complaint received 8 February 2022
Case completed 2 November 2022
