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Bevan Exemplar Cohort 8 Projects

Batch manufacture of OPAT products by Pharmacy Technical Services

Chris Goodwin

Betsi Cadwaladr University Health Board

OPAT is Outpatient Parenteral Antimicrobial Therapy; this is the provision of intravenous antibiotics to patients in their home through the use of elastomeric ambulatory infusion devices. These treatments are offered to patients requiring long term antibiotic therapies for a range of indications.

Within Wrexham, OPAT is being carried out on a small number of suitable patients, approximately 2 per month. The devices required are sourced from an external manufacturer at great cost and the logistical implication that once a suitable patient is identified the manufacturer must be notified before 12:00 PM for a 48-hour delivery (Monday – Friday), pay a significant fee for next day delivery or face a delay in the start of this treatment. This is a limiting factor in the expansion and wider adoption of the OPAT model within YMW and across BCUHB.

This project looks to bring the production of OPAT devices in house to Pharmacy Technical Services. Where the latest aseptic manufacturing technologies will be used to develop and produce a high volume batch manufactured product.

By manufacturing these products in-house, the following benefits will be realised:

•           Elimination of the minimum 24-hour lead-time

•           Cost reduction

•           Enhanced patient experience

•           Improved patient flow

•           Efficient production

Once this initial product is in place, the OPAT programme can be expanded to a wider range of patients and indications leading to a paradigm shift in the way antimicrobial therapies are offered by BCUHB.

A Final Update:

As the Bevan Exemplar programme reaches its end (and as I haven’t posted anything for a while!) I thought that I should provide one final update on where the project started, where we are now and what we hope to do in the future.

Looking back to around 15 months ago, when I first had discussion with the Lead Antimicrobial pharmacist about whether we could help scale-up his OPAT service, what we set out to do was very ambitious. Perhaps it was a little too ambitious but despite the numerous barriers we have encountered along the way, the project has been more successful than we thought and in some quite unexpected ways.

At the beginning of the project we determined that automation would be required to make this a reality and this brought on a whole of challenges that we had not foreseen, software bugs and part obsolescence to name a few. Despite these, however the benefits were quickly realised and reducing the production time from 5 hours to 45 minutes is well worth overcoming the occasional glitch. Our experimentation with technology and automation this past year will have a knock on effect on the coming years as we look to integrate this more into our existing process and development of any new projects.

The stability studies we set out to do on the product formulation generated results that were in excess of the initial predictions. Where I was quietly confident of achieving a 4 week shelf life in the a fridge (double that available at the start) we managed to get 7 weeks and that could have been more had I not run out of samples!! A lesson learnt for next time. Not only that but we were able to generate data at room temperatures which would be greatly important taking the project forward as it would enable easier storage in patients’ home when the service gets that far.

We have had some wonderful support from the commercial sector as well which has led to us being able to produce the products at a much lower cost than would be possible were we to buy them in, going forward this is an excellent step towards the accessibility and scalability of the OPAT service. I am hopeful these relationships will carry on and grow with the programme over the next few years to ensure that it is successful, but also that OPAT can become available to a much wider client base.

There are a couple of gaps in the project as we come to the end; one is a technical issue, the other a little more disappointing. One of the goals was to use the gassing isolators; unfortunately, these were decommissioned over the summer due to obsolete parts and the cost to get them back up and running was a little bit too high. As we demonstrate the value of Technical Services based manufacture, I am sure we will get these back on line, this will increase capacity and also provide additional sterility assurance to the products. The other elephant in the room is that we have only been offer the service to 2 patients so far due to capacity issues currently faced within Wrexham’s Technical Service (not from lack of asking!). Fingers crossed that over the next few months we will be able to put all of the good work that has been done into practice and, realise the benefits we have demonstrated.

The Exemplar Programme has been a great experience over the last year and has really provided an opportunity to drive this project forward, which has been brilliant, as sometimes the innovative and the new get lost in the day-to-day business. The skills and mentorship it has provided have been invaluable to getting the project to where it is. Although it may be a bit late for the project report (sorry Bevan team!) a lot of traction and momentum is now building behind the idea of making OPAT within Technical Services and the next few months and years ahead look very exciting.

Watch an update on the project:

Read Chris’ blog post

Blog post

Poster Presentations

We presented at the Quality Assurance Symposium in September 2023 and the Clinical Pharmacy Congress in November 2023. Take a look at the poster presentations below.

Patient Experience

The first doses of OPAT flucloxacillin were actually produced for one of our very own team members! Using their own initiative, they suggested the OPAT service to their doctor and helped to arrange it for themselves. They have now made a full recovery and have been kind enough to provide some insight on their experience of the OPAT service.

“I was admitted to Wrexham Maelor Hospital with suspected septic arthritis, following this I underwent surgery on my knee and was then admitted to Mason ward where I began receiving IV Flucloxacillin treatment. After a few days on the ward, I was feeling more like myself and was given the opportunity to continue my treatment as a part of the Outpatient Parenteral Antibiotic Therapy project. I, of course, agreed to this and was very pleased that I would be going home sooner than I initially thought.

I was briefed by a Pharmacist upon being discharged on how to correctly use the flucloxacillin pump, this gave me confidence to use the pump under my own supervision away from the healthcare setting. The Pharmacist was very thorough when explaining this to me and ensured I was happy with the outcome. I was also given a demonstration by a nurse on the IV suite on how to safely change the pump once it had emptied and briefed on the infection prevention measures I had to adhere to. The information I was given allowed me to continue with the OPAT at home where I was more comfortable and could begin recovering on my own. I was also pleased knowing that I would not be stuck on the ward unnecessarily and that I would be freeing up a space on the ward for a patient that needed it more than myself.

The OPAT service is massively beneficial for those that are able and want to go home whilst also continuing their treatment. In my case, my preferred option was to do this, so I was extremely pleased when given the opportunity to do so. The OPAT service allowed for a quality of life improvement for myself along with my family members that would no longer have to come visit me on the ward, whereas I felt more comfortable being at home where I was able to both continue with my treatment and recover in a more familiar environment. I was also able to speed up the rehabilitation process due to being at home and having more space to carry out the stretches and exercises I was advised to do by the physiotherapy team.

I was very satisfied with the support the OPAT team provided, my care was carried out professionally and efficiently and I was listened to when I had any questions regarding the treatment.

Unfortunately, whilst I was able to return home, I was unable to return to work due to the nature of my job working in aseptic preparation services, where these pumps that are a part of the OPAT service are actually manufactured – It would have been an infection risk for me to return to work.

The only downside I can think of with the OPAT service is how at times I found it  difficult to change the pump with just one hand, however this was made easier with the help of my partner – This may be an issue for those that live alone or are unable to rely on others for assistance.

I would absolutely use the service again, I think it is a fantastic idea with many benefits for both hospital staff and the patients involved – I would, without a doubt recommend the service to those that meet the criteria to receive it. I think the idea of the service is something that should become more mainstream and of common knowledge so that patients may request the service if they are not offered it in the first place.”