Medicines and Healthcare products Regulatory Agency

Disputed (AI summary) Amgen believes that cardiac monitoring guidance is already definitively outlined in the prescribing information for Kyprolis, and that no further revisions to the SmPC are required. However, they will continue to conduct ongoing pharmacovigilance of Kyprolis and evaluate their SmPC guidance on cardiac monitoring. The case is being used to highlight to ED medical staff the importance of noting abnormal blood test results and ensuring appropriate follow-up, and work is ongoing to highlight the importance of reviewing test results on inpatients daily. A Safety Net is being prepared, and KCH and the PRUH standard lab comments to GP‟s for outpatient Biochemistry will be aligned. The MHRA considered whether the statutory information currently provided by the marketing authorisation holder for prescribers and patients on the safe use of carfilzomib is adequate. The statutory product information for cyclophosphamide and dexamethasone was also considered.

Disputed (AI summary) MHRA has discussed the QA3 instructions for use with the manufacturer, advising them to review them again to ensure that they are still accurate and appropriate. MHRA contacted four other Hospital Trusts via our Medical Device Safety Officer (MDSO) network, each of which have over one hundred QA3 trolleys in use, to establish whether they have had this problem but had not reported it to MHRA. AneticAid defends the design and safety record of its QA3 trolley, arguing that no retrospective changes are needed. They suggest the issue is localised to Royal Berkshire Hospital and will continue to provide training and support to the hospital staff. Royal Berkshire NHS Trust has contracted with Anetic Aid (AA) to undertake periodic inspection and maintenance on all of its QA3 trolleys. The Trust has further updated its Clinical Engineering Checklist for AA QA3 trolleys to expressly detail the checks that must be undertaken during every inspection of a QA3 trolley.