The Pharmacy Aseptic Unit at the Medway Maritime Hospital has introduced the Ultimate™ system to ensure that all aseptically prepared drugs are correctly labelled
Khalid Abdalla MA MPharm
Pharmacy Aseptic Services Manager,
Medway Maritime Hospital, Kent, UK
Medway Maritime Hospital is a general hospital in Gillingham, UK, within the NHS South East Coast. It is Kent’s largest and busiest hospital, dealing with around 400,000 patients annually. The hospital has 588 beds in 29 wards in five main departments: Accident and Emergency; Adult Medicine; Surgery and Anaesthetics; Children and Women; Clinical Support Services. The hospital is run by the Medway NHS Foundation Trust, one of four hospital Trusts in Kent. The Trust employs over 3500 staff.
In the past
The Pharmacy Aseptic Unit previously produced all manufacturing documents using standard software packages, and labels using inkjet and dot-matrix label printers; however, this system did not allow the data to be stored for future use. Each time a label was produced, the information that had been required to produce the manufacturing documentation had to be re-entered. This was time consuming and could result in transcription errors, thereby increasing the amount of data checking required. It was evident that it was necessary to evaluate alternative available options.
The Ultimate™ software is used to prepare labels for aseptically prepared items within the hospital. The implementation of Ultimate™ has improved the clarity and security of the labels of aseptically made products, mainly prepared as ready-to-use, prefilled syringes and IV bags. Labels are prepared for all named patient, aseptically prepared products when these patients are receiving centralised intravenous additive services items, or total parenteral nutrition bags and syringes for adults, paediatrics and neonates.
However, the most common use for the Ultimate™ system is labelling of cytotoxic drugs for patients attending the day clinic. These comprise >50% of the total activity of the Aseptic Unit, and since the implementation of the Ultimate™ system, the quality of the labels produced has improved markedly. This improvement was partly achieved through the use of thermal printers, which allows improved readability of labels, and better quality of the finished items through the ability to print exclusive designs at no extra cost.
The labels are thus distinctive, clear and easy to read, and personalised to reflect the specific institute’s design, which can be accentuated by incorporating any suitable visual means to produce a professional looking label. The program gives more freedom on formatting of fonts and text boxes and the unlimited possibility of the use of different sizes of labels. All this makes the end process of administering the medication to patients quite effortless and fault free, which prompted ongoing positive feedback from nursing staff throughout the hospital.
One of the most important aspects of the implementation of the Ultimate™ labelling system is that the risk of errors has been reduced considerably; this follows the need for entering fewer fields using the keyboard than for previous programs. For example, there is the facility to link labels to databases, which allow the patient’s name and hospital number to be entered by typing in the first two letters of the first name and surname. This is achieved by using a database table in which new patients’ details are entered when they start treatment and each being assigned shortcut letters. From that point on, each label is prepared from that database.
Date of manufacture is entered automatically as the current date on the terminal used, and from which the expiry date is calculated automatically by the program (based on validated shelf lives) and entered in the allocated space. The patient dose is one of the few keyboard entries, from which the final volume, as well as the administration rate, can be calculated automatically by the program using a specific formula. Batch numbers are also assigned automatically, based on the order in which the specific preparations are made; batch numbers can be configured by the user and assigned automatically on producing a new label. An added feature is the ability to preview worksheets and labels before printing, which reduces the possibility of errors and allows real-time amendments to the data entered at print time.
The above processes resulted in a substantial reduction in the time spent producing labels, owing to the fact that instead of manually entering approximately nine separate fields on the keyboard, a maximum of four are now required, some of which comprise only codes.
A main advantage of the Ultimate™ labelling system is that it is straightforward to use and requires the minimum of training for new staff members; this means that they are able to start preparing labels and worksheets independently in a short time which, in most cases, is the first day of training on the system. This instils confidence and frees greater staff time to be spent on other activities. This ease of use means that a better skill mix can be achieved by not relying entirely on higher paid technical staff throughout the dispensing process, and the possibility of delegating some of the dispensing responsibilities to non-technical staff.
On average, our Unit produces up to 50 patient work sheets per day, which act as an audit trail for the production process. Producing worksheets manually is labour intensive and time consuming. The manual process usually starts by photocopying approved worksheets and filing them ready for use. On the day of production, these are taken out depending on what is needed for a certain regimen, and then each worksheet is completed manually. This process can be time consuming if it is borne in mind that there is an average of three drugs per regimen, and if this is added to the labelling process, the total production time of manually produced worksheets and traditionally produced labels for one regimen could take up much staff time.
By using the Ultimate Worksheet module, the time taken to produce a worksheet is incorporated into the labelling process, resulting in time-savings of up to 60% for the process. This results in a speedy and reliable process, which utilises fewer staff and takes less time to achieve the same workload.
‘Lean’ pharmacy practices are gaining more popularity in the National Health Service (NHS) because they ensure that resources are fully utilised and staffing is to the correct capacity. The NHS Institute for Innovation and Improvement issues guidelines for organisations that are going lean in the NHS.
Many of the principles covered in this guidance are actually achieved by the Ultimate™ program. The first principle is improving quality and efficiency. The second principle is improving patient care and experience and Ultimate™ achieves this by facilitating a smooth process through production, manufacture and administration, including convenience for manufacturing and administering staff. The third principle is to improve safety by reducing user errors, and Ultimate™ achieves this by placing less emphasis on keyboard entries and assigning most of the label fields to automatic and database-based entries. Another lean principle is reducing waste, and this is achieved by producing labels with fewer errors, which means reducing the re-labelling process, and the numbers of labels and printing rolls.
Another principle is reducing costs, and this is achieved by time savings and the ability to use fewer staff to do the same amount of work. Another principle of lean working is to eliminate delays in production; this is achieved through the easy and speedy production of labels and worksheets, which means that preparations needed at short notice can be prepared in less time than manual processes, and improved staff morale through an easier and more straightforward dispensing process.
The Ultimate™ Worksheet Module generates the pharmacy worksheets, production labels, supplementary labels, patient information leaflets and any other associated documentation as part of the same printing process. A copy of the exact printed label can be included in the worksheet at print time, which means that the requirement to physically append the sample label onto the worksheet is eliminated. All this makes for a highly efficient production process, thereby saving time and making the whole procedure foolproof.
Own Approved Worksheet Templates can be used easily without a requirement to redesign the worksheets. The facility can be linked to any worksheet created in Microsoft Word, and the program allows worksheets and labels to be previewed before printing. It is a validated product with supporting documentation and a validation certificate that is Medicines and Regulatory Health products Agency-, 21CFR Part 11- and Good Automated Manufacturing Practice compliant. It has the facility for mandatory password changes, auto-log out, and a ‘three strikes and you’re out’ function, which makes it secure and safe. One important feature is that it provides an audit trail through the whole process, which means that data can be retrieved and the whole process scrutinised retrospectively.
Extra features of the Ultimate™ system include the Header and Footer module, which produce labels to record how many labels were printed for each product, and a Worksheet Approval Process that allows the approval of new worksheets electronically without the need for retaining a master hard copy. Episys provides affordable telephone technical support, which helps troubleshooting during setup and provides ongoing support to guarantee continued functionality of the program.
There are many features of the Ultimate™ system that make it user friendly. One of these is the Worksheet Approval Process (requires Ultimate™ Approvals Module), which has the following benefits: only approved worksheets can be printed; version numbering can be recorded and updated; and electronic signatures can be used to drive the process.
Another feature is the ability to combine any of the following into the same print job for worksheets, production labels, supplementary labels, barcode labels, header and footer labels, dispatch notes, certificates of compliance and patient information leaflets.
Episys was very helpful from the start in explaining the system and helping us decide how to get the most out of it, by recognising our requirements and suggesting which modules would be most appropriate for our use. Their support has been exceptional throughout the implementation process and there has always been, and remains to be, someone available to help us with any issues.
The Ultimate Labelling system enabled Medway to design, create content for, and schedule and print labels accurately and efficiently. Implementing this system achieved substantial benefits through greater accuracy of labels and a significant reduction in label and worksheet production time, which translates into savings in numbers of staff, reduced labelling error rates and greater clarity of the labels for the benefit of administering staff.
- The system is a robust programme for the preparation of highly adaptable bespoke labels.
- Easy to set up and train staff on the use and management of the system.
- Contains many features, some of which allow the safe use of short cuts and automatic entries.
- A main advantage is the ability of integrating worksheets and labels in one time-saving step.
- Enhanced security providing extensive password control and full auditing of every activity and event within the system and excellent after sale support.