Astellas UK voluntary admission: multiple promotional items missing prescribing information (AUTH/2957/5/17)

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Key facts

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Case	AUTH/2957/5/17
Company	Astellas Pharmaceuticals Limited (Astellas UK)
Issue	Omission of prescribing information in promotional materials referencing multiple medicines
Medicines referenced	Betmiga (mirabegron); solifenacin (Vesicare); Vesomni (tamsulosin/solifenacin); Advagraf (tacrolimus prolonged release capsules); Prograf (tacrolimus capsules)
Scale noted by Panel/company	5 Betmiga items in use at discovery; 46 additional Betmiga items (dating back to 2013) identified; 25 Vesomni items identified; 2 Advagraf detail aids identified
Key dates	15 Feb 2017 (initial discovery/withdrawal of 4 items); 17 Feb 2017 (email to compliance; 5th item withdrawn); 8 May 2017 (compliance action); Complaint received 23 May 2017; Case completed 19 Jul 2017
Regulator informed	MHRA (copied due to potential patient safety impact)
Applicable Code year	2016
Breach clauses	Clause 2; Clause 4.1; Clause 9.1
Sanctions	Undertaking received; Additional sanctions; Advertisement
Appeal Board referral	No (Panel decided not to report Astellas UK to the Appeal Board in this case)

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

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Astellas UK voluntarily admitted that promotional materials referring to both Betmiga (mirabegron) and solifenacin (Vesicare) included prescribing information (PI) for Betmiga only.
It also admitted that promotional material referring to both Advagraf (tacrolimus prolonged release capsules) and Prograf (tacrolimus capsules) did not include PI for Prograf.
The issue was uncovered during investigation of PI issues in another matter (Case AUTH/2939/2/17).
On 15 February 2017, four Betmiga items referencing solifenacin were found and withdrawn the same day; a fifth was found and withdrawn on 17 February.
UK healthcare compliance was notified by email on 17 February, but the healthcare compliance team did not take action until 8 May 2017.
Astellas identified a further 46 Betmiga items (dating back to 2013) referencing solifenacin without Vesicare PI; these had already been withdrawn before the omission was identified.
A further 25 Vesomni (tamsulosin/solifenacin) items were identified that referred to Vesicare (outside of it being a component of Vesomni) without Vesicare PI; these had already been withdrawn.
Two Advagraf detail aids referencing Prograf lacked Prograf PI; withdrawal was initiated immediately on discovery.
Given potential patient safety impact, Astellas copied the MHRA into its letter; the PMCPA treated the voluntary admission as a complaint under the Constitution and Procedure.

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Breach found for omission of required prescribing information across the items in scope.
The Panel ruled that failing to provide PI was serious and that Astellas’ systems (including certification and recertification) had not identified the errors sooner.
The Panel criticised the delay between discovery (15 Feb 2017) and compliance action (8 May 2017) as “totally unacceptable”.
The Panel considered the volume of materials and cross-business-unit nature of the issue reduced confidence in the industry.
The Panel decided not to report Astellas UK to the Appeal Board in this case (noting related, ongoing sanctions in AUTH/2939/2/17).

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