Archive for June, 2017

ABPI suspends Astellas UK for a further year

Posted on June 26th, 2017 by Valorem Life Sciences

Astellas UK’s membership of the Association of the British Pharmaceutical Industry has been suspended for a further 12 months because of a number of “serious breaches” of the Code of Practice.

According to the organisation, recent cases have shown “wholly inadequate oversight and control at both Astellas UK and Astellas Pharma Europe and a ‘lamentable lack of concern for patient safety’,” which nearly led to the company’s expulsion from the Association.

Astellas UK was originally suspended in June last year because of breaches related to an advisory board meeting and deception, including providing false information to the ABPI’s policing arm the Prescription Medicines Code of Practice Authority by Astellas Pharma Europe.

Both companies were re-audited in September 2016 and April 2017, between which time three further cases arising from voluntary admissions were considered by the PMCPA.

These included a lack of oversight and training of agency nurses who delivered patient support programmes, including failing to update them with product changes, and failures to update and provide complete prescribing information for a number of medicines – “again raising very serious concerns around patient safety and revealing multiple failings.”

The companies’ lack of processes with regard to updating prescribing information was described by the PMCPA Appeal Board as “shocking” and Astellas UK’s failure to understand the scale of the problem was concerning, according to the ABPI.

“It is imperative that the October 2017 re-audits show significant progress,” the Association stressed, warning that if significant improvement is not shown at both companies, then the Board “will consider expelling Astellas UK from membership of the ABPI.”

“Breaches of the Code are viewed seriously and matters concerning patient safety are of the utmost concern,” said Lisa Anson, president of the ABPI and chair of the ABPI Board.

“The very seriousness of the matters are reflected by the extension to the suspension and the clear warning that significant improvement is required. Our industry works under strict regulations and any company that fails to meet these standards will be held accountable.”

Source: Pharma Times