Britannia Pharmaceuticals: prescribing information temporarily inaccessible on APO-go website (third-party error) (AUTH/3609/2/22)

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Key facts

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Case	AUTH/3609/2/22
Company	Britannia Pharmaceuticals Ltd
Product	APO-go (apomorphine hydrochloride)
Channel	Promotional website (APO-go website) managed by third-party contractor
Issue	Prescribing information document inadvertently removed from server during remediation; PI tab visible but PI inaccessible (error message)
Trigger	Voluntary admission following internal compliance team discovery
Complaint received	08 February 2022
Case completed	02 November 2022
Applicable Code year	2021
Breach clause(s)	12.1
No breach clause(s)	2, 5.1, 26.1, 26.4
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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Britannia Pharmaceuticals Ltd made a voluntary admission about incorrect prescribing information (PI) availability on the APO-go (apomorphine hydrochloride) promotional website, which was developed/hosted/maintained by a third-party contractor; Britannia had no back-end access.
On 1 February 2022, Britannia’s compliance team found that PDFs in the ‘Resources’ tab under the ‘Healthcare Professional (HCP) only’ section could be accessed directly from Google searches (eg, ‘Crono pump’ or ‘APO-go pen’). These were described as non-promotional device guidance materials intended for HCPs to download and provide to patients prescribed APO-go.
During the third party’s remediation (removing old PDFs and restricting access to new PDFs), the third party inadvertently removed the PI document from the server without realising; the PI tab remained visible but produced an error when clicked.
On 2 February 2022, Britannia identified via a spot check that PI was inaccessible and instructed the third party to reinstate it; Britannia stated PI was reinstated within two hours of it becoming aware (and accepted PI had been inaccessible for over 24 hours).
Britannia conducted a risk assessment (3 February) and requested an incident report and broader checks to ensure links worked and materials were not publicly accessible without an HCP declaration; it also described preventive measures (monitoring, SOPs/training for the agency, ABPI training, improved PDF storage, additional HCP confirmation before downloading, and plans to move away from the third party in 2022).

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Outcome

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Breach ruled: Clause 12.1 (prescribing information unavailable on a promotional website for a period of over 24 hours).
No breach ruled: Clauses 2, 5.1, 26.1, 26.4.
The Panel noted the case illustrated the need for extreme caution and, wherever possible, ensuring withdrawn material is removed from the internet or securely hidden from view and inaccessible to people outside the company.

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Key facts

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