Case Summary
A complainant who described him/herself as a concerned UK health professional alleged that online prescribing information for Neupro (rotigotine transdermal patch) was out of date. Neupro was indicated, among other things, as treatment for the signs and symptoms of early-stage idiopathic Parkinson’s disease.
The complainant provided a link to, and a screenshot of the prescribing information and noted that rhabdomyolysis, a potential severe side-effect, was not included. The complainant could not remember how he/she had accessed the site but that he/she had done so without using a special username so it would have been via a method available to anyone with an internet connection.
The detailed response from UCB is given below.
The Panel noted UCB’s submission that the only available route to access the page referred to by the complainant would have been by typing the specific URL link quoted by him/her into the browser. It appeared that although the URL provided by the complainant included the name of the website (mypatchandme), the page in question could not be accessed from that website. The Panel noted UCB’s submission that the URL link provided had not been communicated externally; the page referred to by the complainant was only intended for internal use to test specific functionality of the website.
The Panel noted UCB’s submission that the only materials shared externally featured the address www.mypatchandme.co.uk and that the health professional area of the website, accessed using a passcode, included up to date prescribing information. The prescribing information, dated February 2020, listed rhabdomyolysis as a possible side-effect. The Panel further noted UCB’s submission that the health professional area of the website had been certified and was the only area of the website intended for external viewing that included prescribing information.
The Panel queried how the complainant had become aware of, and had accessed, the prescribing information in question given that the webpage in question was only for internal use by UCB. Similarly, UCB had submitted that it was difficult to establish how the complainant had become aware of, and had accessed, the specific page. Despite the fact that the complainant had accessed out of date Neupro prescribing information, the Panel was sympathetic to the company’s submission that the specific URL link used by the complainant had not been communicated externally and that the page in question was for internal use only to test specific functionality. The Panel noted that the complainant could not recall how he/she had accessed the site but had that he/she had done so without a special username whereas UCB had submitted that the health professional area of the website had to be accessed using a passcode. This suggested that the complainant was not on the live mypatchandme website. Although the Panel was concerned that material that did not appear to meet the requirements of the Code had been accessed, that material had not been intended for use outside of UCB. Website analytics provided by UCB showed only two unique visitors and three visits to the page in question.
The Panel considered that, on the balance of probabilities, the complainant had not shown that the page he/she had accessed was intended for health professionals. It seemed reasonable to consider it as material on an internal company-testing site. Although, as acknowledged by UCB, it was unfortunate that the test page had not been removed when the mypatchandme website went live, the Panel decided that what was now out of date prescribing information on an internal, test document, which could not be accessed from the mypatchandme website, did not amount to a breach of the Code as alleged. No breach of the Code was ruled.
The Panel noted that immediately after receiving the complaint UCB removed the page in question. In the Panel’s view, this case illustrated that companies should exercise extreme caution and wherever possible ensure that material, which was for internal use only, was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company.
Although the Panel was concerned that material that did not appear to meet the requirements of the Code had been accessed, given its comments and ruling above, it considered that in the specific circumstances of this case UCB had not failed to maintain high standards. No breach of the Code was ruled including of Clause 2.
CASE AUTH/3353/5/20 NO BREACH OF THE CODE
COMPLAINANT v UCB
Access to website test material
A complainant who described him/herself as a concerned UK health professional alleged that online prescribing information for Neupro (rotigotine transdermal patch) was out of date. Neupro was indicated, among other things, as treatment for the signs and symptoms of early-stage idiopathic Parkinson’s disease.
The complainant provided a link to, and a screenshot of the prescribing information and noted that rhabdomyolysis, a potential severe side-effect, was not included. The complainant could not remember how he/she had accessed the site but that he/she had done so without using a special username so it would have been via a method available to anyone with an internet connection.
The detailed response from UCB is given below.
The Panel noted UCB’s submission that the only available route to access the page referred to by the complainant would have been by typing the specific URL link quoted by him/her into the browser. It appeared that although the URL provided by the complainant included the name of the website (mypatchandme), the page in question could not be accessed from that website. The Panel noted UCB’s submission that the URL link provided had not been communicated externally; the page referred to by the complainant was only intended for internal use to test specific functionality of the website.
The Panel noted UCB’s submission that the only materials shared externally featured the address www.mypatchandme.co.uk and that the health professional area of the website, accessed using a passcode, included up to date prescribing information. The prescribing information, dated February 2020, listed rhabdomyolysis as a possible side-effect. The Panel further noted UCB’s submission that the health professional area of the website had been certified and was the only area of the website intended for external viewing that included prescribing information.
The Panel queried how the complainant had become aware of, and had accessed, the prescribing information in question given that the webpage in question was only for internal use by UCB. Similarly, UCB had submitted that it was difficult to establish how the complainant had become aware of, and had accessed, the specific page. Despite the fact that the complainant had accessed out of date Neupro prescribing information, the Panel was sympathetic to the company’s submission that the specific URL link used by the complainant had not been communicated externally and that the page in question was for internal use only to test specific functionality. The Panel noted that the complainant could not recall how he/she had accessed the site but had that he/she had done so without a special username whereas UCB had submitted that the health professional area of the website had to be accessed using a passcode. This suggested that the complainant was not on the live mypatchandme website. Although the Panel was concerned that material that did not appear to meet the requirements of the Code had been accessed, that material had not been intended for use outside of UCB. Website analytics provided by UCB showed only two unique visitors and three visits to the page in question.
The Panel considered that, on the balance of probabilities, the complainant had not shown that the page he/she had accessed was intended for health professionals. It seemed reasonable to consider it as material on an internal company-testing site. Although, as acknowledged by UCB, it was unfortunate that the test page had not been removed when the mypatchandme website went live, the Panel decided that what was now out of date prescribing information on an internal, test document, which could not be accessed from the mypatchandme website, did not amount to a breach of the Code as alleged. No breach of the Code was ruled.
The Panel noted that immediately after receiving the complaint UCB removed the page in question. In the Panel’s view, this case illustrated that companies should exercise extreme caution and wherever possible ensure that material, which was for internal use only, was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company.
Although the Panel was concerned that material that did not appear to meet the requirements of the Code had been accessed, given its comments and ruling above, it considered that in the specific circumstances of this case UCB had not failed to maintain high standards. No breach of the Code was ruled including of Clause 2.
A complainant who described him/herself as a concerned UK health professional alleged that prescribing information for Neupro (rotigotine transdermal patch) on the ‘mypatchandme’ website was out of date. Neupro was indicated, among other things, as treatment for the signs and symptoms of early-stage idiopathic Parkinson’s disease.
COMPLAINT
The complainant provided a link to, and screenshot of the prescribing information and alleged that it was out of date as rhabdomyolysis, a potential severe side-effect, was not included. The complainant could not remember how he/she had accessed the site but that he/she had done so without using any special username so it would have been via a method that was available to anyone with an internet connection.
When writing to UCB the Authority asked it to consider the requirements of Clauses 9.1, 4.1 and 2 of the Code.
RESPONSE
UCB explained that the mypatchandme website was a patient support resource, reviewed and certified in line with the Code.
The page of the website with prescribing information, as referred to in particular by the complainant, was set up to test specific functionality of the website; as it was only intended for internal use, it was not subject to the standard review and certification process.
The health professional area of the website, accessible with the use of a passcode, included up to date prescribing information and had been certified. This was the only area of the website intended for external viewing that included prescribing information. A downloaded copy was provided.
UCB stated that with regard to the page submitted by the complainant, there were no links (direct or indirect) or tabs that would allow an external user to navigate to that page from within the website itself. The only available route to access the page would have been via the specific URL link quoted by the complainant, typing it into the browser exactly as quoted. However, the link itself was not communicated externally, nor included in any of the materials distributed to, or shared with, health professionals to raise awareness of the availability of the resource. The only materials shared externally featured the address www.mypatchandme.co.uk. An example of such communication was provided. UCB also provided an illustration of the typical user journey to access the health professional dedicated area of the website.
UCB stated that its investigation, which included examination of the website analytics, showed that there were only two unique visitors and three visits to the page in question (ie one of the visitors accessed the page twice). Website analytics allowed collection, tracking, measurement and analysis of website data including being able to verify the number of visitors to the specific pages. According to the data, the two visits took place on 26 May 2020, the date UCB received the complaint. Both visits were by two members of the investigation team. Considering the link to the page was not communicated to the external audience, and taking into account the outputs of the internal investigation (as outlined above), it was difficult to establish how the complainant had become aware of, and had accessed, the specific page.
UCB stated that, by omission, the specific page referred to by the complainant remained active in the content management system when the website went live. Immediately, after receiving the complaint the page was removed. UCB recognized that the page should have been removed once testing was completed and that failure to do so was an oversight. Accordingly, UCB would revise its internal processes and guidelines on managing digital assets. However, in contrast with the allegations raised, the up to date prescribing information was available on the website and included in the certified materials intended for external use.
UCB stated that it was committed to maintaining high standards and ensured changes to prescribing information were managed appropriately. A copy of the relevant internal standard operating procedure (SOP) was provided.
In conclusion, UCB denied the complainant’s allegations and therefore denied any breach of Clauses 4.1, 9.1 and 2.
PANEL RULING
The Panel noted that the complainant had provided a screenshot of, and a URL link which included reference to the mypatchandme website to, Neupro prescribing information and alleged that it was out of date as it did not list rhabdomyolysis as a possible severe side-effect.
The Panel noted UCB’s submission that the only available route to access the page referred to by the complainant would have been by typing the specific URL link quoted by him/her into the browser. It appeared that although the URL provided by the complainant included the name of the website (mypatchandme), the page in question could not be accessed from that website. The Panel noted UCB’s submission that the URL link provided had not been communicated externally; the page, as referred to by the complainant, was only intended for internal use to test specific functionality of the website and was therefore not subject to the standard review and certification process.
The Panel noted UCB’s submission that the only materials shared externally featured the address www.mypatchandme.co.uk and that the health professional area of the website, accessible with the use of a passcode, included up to date prescribing information. The Panel noted that the prescribing information on the health professional section of the mypatchandme website, dated February 2020, listed rhabdomyolysis as a possible side-effect, albeit that its frequency was not known. The Panel further noted UCB’s submission that the health professional area of the website had been certified and was the only area of the website intended for external viewing that included prescribing information.
The Panel queried how the complainant had become aware of, and had accessed, the prescribing information in question given that the webpage in question was only for internal use by UCB. Similarly, UCB had submitted that it was difficult to establish how the complainant had become aware of, and had accessed, the specific page. Despite the fact that in May 2020 the complainant had accessed Neupro prescribing information dated September 2019, which did not include rhabdomyolysis as a possible adverse event, the Panel was sympathetic to the company’s submission that the specific URL link used by the complainant had not been communicated externally and that the page in question was for internal use only to test specific functionality. The Panel noted that the complainant could not recall how he/she had accessed the site but stated that he/she did not have to use any special username to access the material in question whereas UCB had submitted that the health professional area of the website had to be accessed using a passcode. This suggested that the complainant was not on the live mypatchandme website. Although the Panel was concerned that material that did not appear to meet the requirements of the Code had been accessed, that material had not been intended for use outside of UCB. In that regard, website analytics provided by UCB showed that there were only two unique visitors and three visits to the page in question (ie one of the visitors accessed the page twice). According to the data, the two visits took place on 26 May, the date UCB received the complaint both of which were by two members of the investigation team.
The Panel considered that, on the balance of probabilities, the complainant had not shown that the page he/she had accessed was intended for health professionals. It seemed reasonable in this case to consider it as material on an internal company-testing site. Although, as acknowledged by UCB, it was unfortunate that the prescribing information in question had not been removed from the content management system once testing was completed and the mypatchandme website went live, the Panel decided that what was now out of date prescribing information on an internal, test document, which could not be accessed from the mypatchandme website, did not amount to a breach of the Code as alleged. No breach of Clause 4.1 was ruled.
The Panel noted UCB’s submission that it recognized that the specific page referred to by the complainant remained active in the content management system when the website went live and that it should have been removed once testing was completed and that failure to do so was an oversight. The Panel noted that immediately after receiving the complaint UCB removed the page in question. In the Panel’s view, this case illustrated that companies should exercise extreme caution and wherever possible ensure that material, which was for internal use only, was either removed from the internet or securely hidden from view and was thus inaccessible by people outside of the company.
Although the Panel was concerned that material that did not appear to meet the requirements of the Code had been accessed, given its comments and ruling above, it considered that in the specific circumstances of this case UCB had not failed to maintain high standards. No breach of Clause 9.1 was ruled. The Panel also ruled no breach of Clause 2.
Complaint received 23 May 2020
Case completed 29 March 2021
