The COVID-19 pandemic has presented secondary care with a unique set of challenges, but also many opportunities to explore new and innovative ways of working and partnering in response.
At Surrey and Sussex Healthcare NHS Trust, amongst these challenges was how to meet the sudden increase in demand for intravenous antibiotics associated with empirical prescribing on initial presentation of the patient and secondary bacterial infections in known COVID-19 patients.
Compounding this was the further obstacle of depleted numbers of front-line nursing staff due to shielding and self-isolation, along with nurses being deployed to unfamiliar clinical environments and encumbered by PPE. The pharmacy team were concerned that this combination of challenges could result in reconstitution errors, missed doses or significant variation in dosing intervals which could have tangible impacts on treatment efficacy and/or patient safety.
We were also mindful of the need to act quickly to find a solution to ensure that the Trust was best prepared for the anticipated peak of patients presenting with the COVID-19 infection.
At the peak of the pandemic – 1000 doses of IV antibiotics were prepared and supplied to clinical areas, enabling ward-based nurses to focus on caring for their patients.
The pharmacy team began to see an opportunity: Could nurses who were unable to work on the frontline but familiar with the process of preparing IV medicines form an IV antibiotic reconstitution team? They could work away from the ward area, thus releasing nurses on the wards for other tasks and mitigating the risks that we had identified?
The Trust has no aseptic dispensing facilities, but having temporarily halted elective surgery, the possibility of using an empty laminar flow operating theatre as a clean area in which to prepare IV antibiotics was proposed. The Trust Board requested that pharmacy take the lead and begin to look for an appropriate solution consistent with the regulatory framework.
Section 8 of the Medicines Act 1968 states that persons may only manufacture or assemble any medicinal product under a manufacturer’s licence, which the Trust does not currently have. The Section 11 exemption (which previously facilitated the assembly of medicinal products by nurses and midwives in the absence of a manufacturer’s licence) was subsequently replaced by new provisions in the Human Medicines Regulations 2012. Part one Section 3 states that a manufacturing licence is not required if:
- The medicinal product is assembled by a registered nurse
- The nurse is acting within the course of their profession
- The product is supplied to a patient in the course of the treatment of that patient
- Is not manufactured in large scale or by industrial process.
After careful review of these criteria, the pharmacy team determined that a service could be provided under this provision, with nurses reconstituting IV antibiotics. Whilst not a requirement of the legislation and relevant exemptions, it was also agreed by the Trust that the activities would be carried out under the leadership and direct supervision of a pharmacist, adding a further layer of assurance. Additionally, to maximise mitigation of risk, processes were designed to adhere as closely as possible to the GMP principles described within The Orange Guide.
The pharmacy team collated stability data for the most frequently used IV antibiotics, ensuring that the range reflected the Trust antibiotic prescribing guidelines and principles of antimicrobial stewardship. It was agreed that, even where the data supported a longer period, a maximum expiry of 24 hours after preparation would be assigned and that batch sizes would not exceed five items. This approach was supported by COVID-19 guidance documents, worksheet templates and recommendations published by the NHS Specialist Pharmacy Service.
Over a period of four weeks – at the peak of the pandemic – 1000 doses of IV antibiotics were prepared and supplied to clinical areas, enabling ward-based nurses to focus on caring for their patients. With a reduction in the number of COVID-19 positive patients now presenting to the hospital the service has been paused but placed on standby so that it can be resumed in the event of a second wave.
Alongside this, work is underway to determine if there would be value in the team preparing a wider range of products, particularly those which may be of particular use in critical care areas.
This project has presented a novel opportunity for the NHS team to work with partners from industry. In this case, a Pfizer initiative established at the beginning of the COVID-19 crisis that enabled its staff to volunteer in the NHS meant that clinical expertise of NHS staff could be supported by a broader project management and senior stakeholder engagement skill set.
Additionally, the opportunity to assign a specifically dedicated resource to this high-profile initiative meant rapid progress could be made whilst enabling the Trust team to continue to focus on the significant clinical pharmacy services required during the crisis. It is hoped that this successful experience will be the basis for further partnership working opportunities for the future.
The COVID-19 pandemic has required the NHS to rapidly develop solutions to address unforeseen difficulties. The service described above demonstrates that pharmacy is well placed to design and implement innovative, safe and practical solutions to these challenges.
This article has been co-authored by Chris Bidad, Global Senior Director at Pfizer UK. Chris started his career in the NHS as a clinical pharmacist before joining Pfizer in 2006. During his 14 years at Pfizer he has held positions within Medical, Commercial and Access at local, regional and global levels. In his current role he focuses on ensuring and improving access to Pfizer’s broad portfolio of medicines. Chris can be reached on Twitter @BidadChris.
The opinions expressed in this article are those of the author. They do not purport to reflect the opinions or views of the UKCPA or its members. We encourage readers to follow links and references to primary research papers and guidance.
Competing interest statement:
The authors declare: no support from any organisation for the submitted work; JR declares no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; CB declares he is employed by Pfizer; no other relationships or activities that could appear to have influenced the submitted work.