Public reprimand for Astellas UK

Patient support programmes

Astellas UK has been publicly reprimanded by the Code of Practice Appeal Board for a lamentable lack of concern for patient safety and wholly unsatisfactory oversight and control of two patient support programmes and of the nurses employed to deliver them (Case AUTH/2883/10/16).

Astellas UK had voluntarily admitted multiple failings in this case concerning its patient support programmes, Fresh Start and VIP which related to Betmiga (mirabegron) and Vesicare (solifenacin succinate) respectively. Both medicines were for patients with overactive bladder syndrome. The Code of Practice Panel was extremely concerned and noted its rulings including breaches of Clause 2. Some of the matters raised went to the heart of self-regulation and patient safety. Notwithstanding the fact that Astellas UK was currently suspended from membership of the ABPI and already undergoing a series of audits of its procedures under the Code (Case AUTH/2780/7/15), the Panel reported Astellas UK to the Appeal Board. The Appeal Board considered that this case raised serious concerns which were entirely unacceptable.

The Appeal Board was minded to report Astellas UK to the ABPI Board but given the exceptional circumstances, including that the re-audits in Case AUTH/2780/7/15 were due to be carried out very shortly, it decided that the issues that had arisen in this case
(AUTH/2883/10/16) should be looked at as part of the upcoming re-audit of Astellas UK. On consideration of the report of the re-audits the Appeal Board decided to report Astellas UK to the ABPI Board.