Pilot of the Pharmacy Software Program BD Cato at Velindre Cancer Centre

Martin Rees-Milton

Velindre NHS Trust

The manufacture of cytotoxic drugs and Systemic Anti Cancer Treatments (SACT) is a high risk process. Within the NHS, drugs are prepared in pharmacy aseptic units to rigorous and highly regulated quality standards, described below. Currently ensuring compliance with Good Manufacturing Practice (GMP) is predominately a manual process, thus subject to the risk human error and potential risk of significant harm to patients.

GMP is the quality system for ensuring that drug products are consistently produced. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product, and covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.

BD Cato is a software program developed by Becton Dickinson, which supports pharmacy manufacturing of SACT drugs whilst maintaining quality standards. It allows the removal of the risks associated with human error; it has been designed to reduce medication errors, waste reduction and automate some of the in-process QA (Quality Assurance) manual checks. It is proposed to pilot BD Cato at the pharmacy department Velindre Cancer Centre.

Interventions and Actions

Preparing for Pilot:

Change management, including:

This Project Supports Prudent Healthcare

Impact of people time: The manufacturing of an aseptic product has several Quality Assurance (QA) in-process manual checks to ensure the final product is prepared to GMP; it is estimated that these manual checks take 2 minutes per item. Totaling up the daily workload and staff time, the system frees up 2 hours daily across multiple staff groups which will support additional capacity within Velindre Cancer Centre across multiple staff groups, enabling additional workload without additional expenditure.

Error reduction: Analysis from UK NHS aseptic units’ shows that out of 210,000 aseptic items dispensed, these manual in-process QA checks found 1700 errors. Further analysis of these errors indicated that 64% of these errors could have been prevented using an automated software system.

Cost savings: When a drug vial is part used to prepare a dose of SACT for one patient and later the remainder is used to prepare a dose of SACT for another it is termed a Part Used Vial (PUV). If a PUV cannot be reused it must be discarded, an audit at Velindre estimated that £1,500.00 a week is wasted by discarding PUVs. BD Cato is able to schedule the workload to allow the manufacture of the same products consecutively, reducing the PUV wastage.

Anticipated Benefits

Part of Cohort Bevan Exemplars 2015-16