Risk-based implementation plan

The Cytocare robot is projected to handle a steadily increasing proportion of the total cytostatic workload in its the first year of operation at Charing Cross Hospital in London. Ann Jacklin, Chief of Service, Pharmacy and Therapy Services, explains how a risk-based approach was used to plan the ‘go-live’ strategy for the SafeChemo project

At Charing Cross Hospital in London the SafeChemo project was underpinned by an Operational Outline Plan. The plan described the Cytocare robot, its capabilities and the way in which it was expected to meet local needs. It also listed all the questions that had to be answered before the robot could be put into routine operation. “Our first operational outline plan had more questions than answers”, says Ann Jacklin, Chief of Service, Pharmacy and Therapy Services. Here she describes how several streams of activity were co-ordinated so that a smooth go-live process was achieved.

The overall vision for the use of Cytocare was that the robot would effectively work alongside the existing isolator technology and process a large proportion of the current workload. This would have several benefits – relieve staff of a heavy manual workload, reduce costs and retain flexibility in the system (because the equipment and skilled staff would still be available to handle complex or unusual products).
Critical elements of the process were:

• microbiological validation, including validation of the cleaning process
• mechanical and process validation
• agreement about the products to be made
• preparation of standard operating procedures,
• training of staff

One key question was whether to start with a single drug or several drugs. The team at Charing Cross decided to adopt a risk assessment approach. “You need to look at products in terms of the complexity of preparation and start with the least risky items - simple solutions”, advises Ann. “We decided to phase the introduction of products starting with a single drug solution – 5-fluorouracil - that was drawn up into syringes. This means that in the first instance we were not relying on the robot to perform any calculations or dilutions, in contrast to, say, reconstitution of a dry powder followed by a dilution”.
The initial plan involved introducing products in the following sequence:
Phase 1: Simple drug solution drawn up into syringes
Phase 2: Simple drug solution added to bags of intravenous fluid
Phase 3: Dry powder reconstituted and drawn up into syringes
Phase 4: Dry powder reconstituted and added to bags of intravenous fluid

“In this way we could gradually get to know the capabilities of the equipment as we went along. It is a matter of balancing the gain in experience with making the best use of the robot”, says Ann.

Which drugs?
When considering which drugs to prepare in the robot the Charing Cross hospital team listed all the cytostatic agents that are used in the hospital and asked the question, “Is this suitable for preparation by Cytocare and if so, in which phase?” Critical factors were the complexity of the preparation procedure, whether large quantities were used and whether standard volumes were used. This enabled the team to devise lists of products suitable for each phase of the project and to eliminate unsuitable products. For example, large numbers of doses of carboplatin and cisplatin are used at Ann’s hospital. The doses are prepared by adding drug in solution to intravenous bags and are therefore suitable for phase 2. In contrast, cytarabine is technically suitable for inclusion in phase 2, but it is rarely used at Ann’s hospital and therefore not worth including in the plan.

Going live – the reality
Preparation of 5-fluorouracil in syringes started at Charing Cross Hospital in November 2008. The preparation of 5-fluorouracil in intravenous bags followed in January 2009 and preparation of carboplatin and cisplatin bags will come on stream soon. In early March, another development was the preparation of 5-fluorouracil syringes and bags for Hammersmith Hospital – some 6 kilometres distant from Charing Cross Hospital. This meant that the team had to consider the logistics of preparing the injections in advance. “We receive the orders one week ahead of the day of treatment and build them into the production schedule so that the doses can be delivered to Hammersmith Hospital before the day of treatment, explains David Leonard, Executive Lead Pharmacist Aseptics and Clinical Trials, Imperial College Healthcare NHS Trust.

The three drugs, 5-fluorouracil, carboplatin and cisplatin, account for 26% of the total number of cytostatic doses prepared at Charing Cross Hospital. “Preparation of these items by the Cytocare robot will improve our capacity considerably”, says Ann. “Overall, we are less interested in what the robot could do technically and more interested in how we can use it to benefit our service and this is the thinking that guides our approach”, Ann emphasises.