St. Mary’s Pharmaceutical Unit guarantees medicines labelling

Published 9th September 2008

Summary

St. Mary’s Pharmaceutical Unit is one of three units run by the Cardiff & Vale NHS Trust, which produce batches of medicines for specific patient needs and which are not commercially available. Typically these are liquid versions of medicines, which are commercially available in tablet form, for paediatric use.

Challenge

St. Mary’s Pharmaceutical Unit has an MHRA (Medicines and Healthcare products Regulatory Agency) specials manufacturers licence which allows them to produce special individualised medicines for sale to hospitals within the Cardiff & Vale NHS Trust, as well as other hospitals throughout Wales. They also overlabel and then repackage medicines for their own and other trusts.

The challenge facing St. Mary’s Pharmaceutical Unit is that 80% of errors in pharmaceuticals occur on labelling so it is extremely important to ensure that they have a label design which is accurate, readable and reproducible. The functionality of their existing label system was limited, so they therefore looked for a replacement system which would allow them to correctly validate all label data, and provide the facility to lock all the data files for each label to comply with the regulatory requirements of the MHRA.

Solution

St. Mary’s chose the Episys Ultimate system because of the extra functionality it provides over the existing Episys Elite system. The improved security and validation functions provided by Episys Ultimate were the main advantages over the old Elite system. Cardiff and Vale NHS Trust is running four standalone Episys Ultimate systems at their three sites: two at St. Mary’s and one at each of the two other hospital sites.

Episys Ultimate allows control over which modules of the system can be used by individual operators while supervisors can use all modules. This means that operators can be restricted to just printing labels. The system also has a full audit trail with report functionality which allows any problems to be fully investigated.

Episys has recently released a label approval module for Ultimate which St. Mary’s are planning to use. This module will replace the existing paper based approval system and allows label designs to be emailed for approval and then signed off electronically. Once a label is approved it is locked so that operators can’t change it. This module also prevents unapproved labels being printed accidentally.

The validation part of the system shows that the software has been tested thoroughly in-house. This will be valuable during MHRA inspections because St. Mary’s have all the documentation available for inspectors to use during their audit.

Episys Ultimate also allows EAN-13 barcodes to be added to label designs. Barcodes have been shown to reduce errors with medicines within hospital wards and for other end users.

Ultimate has equation and formula functionality with the labelling system which allows date of manufacture and expiry to be calculated. Using the Open Database Connectivity (ODBC) it is also possible to import information from other software. This function is potentially useful at the two hospital sites to import data from their patient information system when they manufacture medicines for individual patients. St. Mary’s are looking into holding electronic batch books in Microsoft Excel, containing product information and batch numbers. This data can then be imported into Ultimate.

St. Mary’s is planning to make use of headers and footers within Ultimate labelling to audit the production of labels. It is working on a footer which will contain information such as number of labels printed, time of printing and operator name. This can then be attached to the batch documentation to provide a paper based audit trail.

St. Mary’s also buy consumables from Episys, ribbons and labels, and have their hardware maintained under a contract with Episys, therefore they only have one point of contact for any issues which arise with the system. Alex Bosley, Production Manager at St Mary’s, said, “using one company for the whole system makes the process a lot easier.”

Benefits

The various modules available within the Episys Ultimate system allows St. Mary’s to comply with all the MHRA regulatory requirements. It allows individual files to be locked and individual operators to have limited access to specific modules.

The label approval module speeds up the approval process and reduces the amount of paper handling. It also prevents unapproved labels being printed.

Alex Bosley said, “Episys have been incredibly supportive not only with the consumables which are always delivered in a very timely fashion, and any problems we have are always dealt with very efficiently.”

The Future

Alex Bosley again, “One of the aims of the Trust is to get a corporate image on some of the labels and possibly the use of colour on labels as well.” Judicious use of colour on labels may be used in the future to identify groups of medicines.

In addition St. Mary’s its interested in extending its use of the system to print on the boxes used as secondary packaging of the medicines.
St. Mary’s is considering making use of Episys’ consultancy service to update its label designs and ensure that only current designs are held on the system.

Another possible future application is the use of handheld barcode readers within St. Mary’s stores to pick orders for dispatch and distribution.

Alex Bosley concluded, “Cardiff and Vale NHS Trust have an excellent services from Episys and we’re looking forward to continuing in the future.”